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Syngene International

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Bangalore, IN

About Syngene International

Founded: 1994 Type: Public Company Size: 1001-5000 employees

Incorporated in 1993 as a subsidiary of Biocon Limited, Syngene is a leading custom research and manufacturing organization, which supports R&D programs from lead generation to clinical supplies. Our multi-disciplinary skills in integrated drug discovery and development include capabilities in medicinal... Show more »

Incorporated in 1993 as a subsidiary of Biocon Limited, Syngene is a leading custom research and manufacturing organization, which supports R&D programs from lead generation to clinical supplies. Our multi-disciplinary skills in integrated drug discovery and development include capabilities in medicinal chemistry, biology, in vivo pharmacology, toxicology, custom synthesis, process R&D, cGMP manufacturing, formulation, bioinformatics and drug re-purposing and analytical development along with Clinical development services.

Our highly experienced scientific and project management teams ensure:

  • Timely execution of projects
  • Cost effectiveness and quality of the projects
  • Confidentiality and protection of intellectual property

Syngene has state-of-the-art research facilities certified with ISO 9001:2008, ISO 14001:2004, and OHSAS 18001:2007. Our animal facilities are GLP certified by the Indian authorities and AAALAC accredited. Over the last 20 years, we have successfully offered these services to more than 250 clients including start-up companies, large pharma/ biotech, agrochemical, chemical, nutrition and animal health companies in the USA, Europe and Asia Pacific including Japan.

Syngene has a strong corporate governance framework with a focus on client satisfaction, quality, safety, ethics and integrity. Our ability to deliver significant value to our customers by leveraging our scientific skills, global mind set and India’s cost competiveness differentiates us as one of the most preferred partners.

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Certifications & Qualifications

AAALAC BSL-2 cGMP FDA Inspected GCP GLP ISO 13485 ISO 14001 ISO 15189 ISO 9001 OHSAS 18001

Our Services (168)


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In vivo Bioavailability/Bioequivalence Studies

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Microbial Fermentation and Bioprocessing

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Compound Library Design

Price on request

Syngene provides library design and synthesis services with a solid track record of delivering library sets independently or in collaboration with clients in Pharmaceutical, Agrochemical, Animal Health and allied industries.

Syngene provides library design and synthesis services with a solid track record of delivering library sets independently or in collaboration with clients in Pharmaceutical, Agrochemical, Animal Health and allied industries.

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eCTD Services

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Colitis Animal Models

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DSS-induced colitis in mice
TNBS-induced colitis in mice and rats

DSS-induced colitis in mice
TNBS-induced colitis in mice and rats

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Mouse Rat

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Dermal Toxicity Studies

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Rabbit Mouse Rat Toxicology

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Immunotherapy Screening

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Raw Material Testing

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Animal Immunization for Antibody Production

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Rabbit Mouse Rat

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Omics

Price on request

Our Omics capabilities range from performing sequencing reactions on Illumina MiSeq and NextSeq500 and data analysis in following fields.

• Exome sequencing
• Whole genome sequencing
• RNAseq/Transcriptomics
• ViromeScan
• Base Calling
• Microarray
• Degradomics
• Single cell DNA sequencing
• Single cell RNA sequencing
• Nanostring nCounter
• 16s Metagenomics

Our Omics capabilities range from performing sequencing reactions on Illumina MiSeq and NextSeq500 and data analysis in following fields.

• Exome sequencing
• Whole genome sequencing
• RNAseq/Transcriptomics
• ViromeScan
• Base Calling
• Microarray
• Degradomics
• Single cell DNA sequencing
• Single cell RNA sequencing
• Nanostring nCounter
• 16s Metagenomics

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Photochemical Synthesis

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Oligonucleotide Synthesis

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Syngene’s Oligonucleotide capacity & services ranges from development to cGMP manufacturing of chemically synthesized high quality modified and non-modified custom Oligonucleotide (DNA/RNA), siRNA (single & double stranded, miRNA (modified and non-modified), Antisense, fast delivery of Oligonucleotides at various scales.

A... Show more »

Syngene’s Oligonucleotide capacity & services ranges from development to cGMP manufacturing of chemically synthesized high quality modified and non-modified custom Oligonucleotide (DNA/RNA), siRNA (single & double stranded, miRNA (modified and non-modified), Antisense, fast delivery of Oligonucleotides at various scales.

A highly qualified & experienced team is focused in establishing the technology platform for process development, manufacturing and analytical ensuring global client requirements. We have partnered with various clients’ globally for long term alliances and programs.

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Synthetic Chemistry

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o Synthesis of various heterocycles, scaffolds, building blocks and reference compounds,
o Library synthesis – solution phase and solid phase
o Isolation, synthesis and purification of impurities and metabolites
o Peptide synthesis – solid phase (up to 50 mer) and solution phase
o ADCs – Novel linker and Toxin... Show more »

o Synthesis of various heterocycles, scaffolds, building blocks and reference compounds,
o Library synthesis – solution phase and solid phase
o Isolation, synthesis and purification of impurities and metabolites
o Peptide synthesis – solid phase (up to 50 mer) and solution phase
o ADCs – Novel linker and Toxin synthesis
o Nucleosides - Multistep synthesis of nucleosides involving complex chemistry, synthesis of nucleoside phosphoramidate prodrugs, nucleoside libraries, carbocyclic nucleosides
o Carbohydrates - sugar modifications involving multi-steps, routine functional group transformations on sugars
o OLEDs - synthesis and purification of monomers for organic electronic materials
o Purification by SFC, mass directed prep and reverse phase flash

Discovery Chemistry has a strong track record of successfully advancing the goals of our large collaborations by flexibly tackling a diverse array of tasks such as new analog synthesis for screening, scale-up to the kg level, chemical library synthesis and other tasks required to rapidly advance drug discovery projects. We provide additional value for clients by applying, when required, our significant expertise and capabilities in several specialized high-value chemical classes: nucleosides, carbohydrates, peptides and modified peptides (eg. cyclotides, tagged peptides), antibody drug conjugate (ADC) linker-payload combinations, and PROTACS scaffolds. We learn and apply recent developments from the chemical literature, employing the latest advances in metal mediated coupling reactions, CH activation chemistry, and photoredox chemistry, as a few examples. Additionally, Syngene has specialized platforms for flow and photo-flow chemistry and, as mentioned, chemical library preparation. As an example of the application of the latter platform, we have routinely synthesized and purified libraries of up to 4000 compounds per quarter, both in solution and in solid phase for one of our clients over a period of several years. Purifications are performed in high throughput mode via mass triggered HPLC.
• We regard our problem-solving skills to be world-class and we frequently earn praise from clients who are internationally recognized as scientific leaders. As one of the world’s largest CROs collaborating for over two decades with astute and scientifically demanding clients we have attained a reputation for a consistent track-record of outstanding chemistry problem solving expertise ranging from specific early stage discovery chemistry problems, through to fully integrated drug discovery and development programs.
Discovery Chemistry has a strong track record of successfully advancing the goals of our large collaborations by flexibly tackling a diverse array of tasks such as new analog synthesis for screening, scale-up to the kg level, chemical library synthesis and other tasks required to rapidly advance drug discovery projects. We provide additional value for clients by applying, when required, our significant expertise and capabilities in several specialized high-value chemical classes: nucleosides, carbohydrates, peptides and modified peptides (eg. cyclotides, tagged peptides), antibody drug conjugate (ADC) linker-payload combinations, and PROTACS scaffolds. We learn and apply recent developments from the chemical literature, employing the latest advances in metal mediated coupling reactions, CH activation chemistry, and photoredox chemistry, as a few examples. Additionally, Syngene has specialized platforms for flow and photo-flow chemistry and, as mentioned, chemical library preparation. As an example of the application of the latter platform, we have routinely synthesized and purified libraries of up to 4000 compounds per quarter, both in solution and in solid phase for one of our clients over a period of several years. Purifications are performed in high throughput mode via mass triggered HPLC.
• We regard our problem-solving skills to be world-class and we frequently earn praise from clients who are internationally recognized as scientific leaders. As one of the world’s largest CROs collaborating for over two decades with astute and scientifically demanding clients we have attained a reputation for a consistent track-record of outstanding chemistry problem solving expertise ranging from specific early stage discovery chemistry problems, through to fully integrated drug discovery and development programs.

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Lyophilization

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Spray Drying

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Synthetic Building Blocks and Intermediates

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Antibody-Drug Conjugate (ADC) Development

Antibody Drug Conjugate Development
Price on request

Syngene’s Antibody Drug Conjugate (ADC) unit brings together an array of multidisciplinary capabilities in antibody generation, linker and payload chemistry, conjugation chemistry, in vitro and in vivo oncology in an integrated platform.

The services are offered in integrated, clustered and standalone as needed by our... Show more »

Syngene’s Antibody Drug Conjugate (ADC) unit brings together an array of multidisciplinary capabilities in antibody generation, linker and payload chemistry, conjugation chemistry, in vitro and in vivo oncology in an integrated platform.

The services are offered in integrated, clustered and standalone as needed by our customers

  • Antibody discovery
  • Antibody engineering for conjugation and other optimizations
  • Linker chemistry: Optimization and evaluation, experience of cleavable, self-immolating and non-cleavable linker systems, click Chemistry based linkers, peptide based linkers, dendrimers, etc.
  • Payload chemistry: Novel and standard payloads (Duocarmycin, Auristatin, Tubulysin, DM1, DM4, SN38, Etoposide, Bleomycin, Podophyllotoxin, etc), synthesis and derivatization of Toxins.
  • Conjugation chemistry: Thiol based, using engineered and native Cys residues in antibodies; Lys based and others.
  • Cytotoxic development and cGMP manufacturing
  • Conjugation strategy and process development
  • Conjugation scale up and cGMP manufacturing (Facility upcoming)
  • Analytical method development
  • In vitro evaluation (binding, internalization, potency etc.)
  • In vivo pharmacology (efficacy in tumor models – cell lines & patient derived, pharmacokinetics and toxicology)

Generation and rapid evaluation of ADC panels

Selecting the best mAb and an appropriate linker-payload system for a particular cancer target can be a daunting task at an early discovery stage of ADCs. Syngene offers the capacity to generate a panel of ADCs combining a set of lead mAbs and linker payload systems (non-proprietary and client licensed technologies) at a small scale followed by their analytical, in vitro, and in vivo evaluation.

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Pharmacovigilance and Post-Authorization Safety Studies (PASS)

Price on request

Syngene offers comprehensive pharmacovigilance solutions during both clinical development and post-approval phases. The pharmacovigilance team comprises clinical pharmacologists with in-depth knowledge in diverse therapeutic areas and several years of pharmacovigilance and safety management experience. Syngene has set up dedicated... Show more »

Syngene offers comprehensive pharmacovigilance solutions during both clinical development and post-approval phases. The pharmacovigilance team comprises clinical pharmacologists with in-depth knowledge in diverse therapeutic areas and several years of pharmacovigilance and safety management experience. Syngene has set up dedicated 24/7 phone and fax lines to receive information on adverse events from clinical trial sites and post-marketing sources.

Our range of pharmacovigilance services include:

  • Set up and maintenance of global safety database
  • Collection, evaluation, analysis and reporting of safety information from all sources including spontaneous reports of adverse events of the marketed drugs
  • Literature search in compliance with regulatory requirements
  • Medical review of case reports
  • Online coding (MedDRA, WHO DDE) of adverse events
  • Preparation of safety narratives
  • Preparation and submission of Periodic Safety Update Reports (PSURs) to regulatory authorities
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Medical Writing

Price on request

Syngene has a team of experienced medical writers with scientific expertise to provide high quality clinical study documents (including eCTDs) compliant with ICH guidelines and regulatory requirements. From protocol writing to the final report preparation, our medical writers collaborate with biostatisticians and project team... Show more »

Syngene has a team of experienced medical writers with scientific expertise to provide high quality clinical study documents (including eCTDs) compliant with ICH guidelines and regulatory requirements. From protocol writing to the final report preparation, our medical writers collaborate with biostatisticians and project team members to produce comprehensive, submission-ready documents for all stages of clinical development. Every document goes through a rigorous internal quality assurance process ensuring high quality deliverables on time. We provide medical writing services as part of the comprehensive clinical trial program or as a stand-alone service.

Our medical writers help you in the preparation of the following documents:

  • Investigator brochure
  • Clinical study protocols
  • Informed consent forms
  • Study assessment questionnaires
  • Patient diaries
  • Clinical study reports – phase I to IV
  • Abstracts and manuscripts
  • Clinical overview and clinical summary (sections 2.5 and 2.7 of CTD)
  • DSMB manuals
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In vitro Immunogenicity Assays

Price on request

Syngene's GLP-certified Bioanalytical Laboratory for Large Molecules specializes in immunogenicity and pharmacokinetic (PK) analysis of biologics and biosimilars. The laboratory has extensive experience in working with monoclonal antibodies, recombinant proteins, enzymes, biomarkers, cytokines and growth hormones during the early... Show more »

Syngene's GLP-certified Bioanalytical Laboratory for Large Molecules specializes in immunogenicity and pharmacokinetic (PK) analysis of biologics and biosimilars. The laboratory has extensive experience in working with monoclonal antibodies, recombinant proteins, enzymes, biomarkers, cytokines and growth hormones during the early and late phases of the drug development (preclinical and clinical) process.

Numerous immunogenicity assays are offered (including screening, confirmatory, titre assessment, antibody isotyping and cell based neutralizing antibody assays).

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Clinical Trial Management

Price on request

Syngene's clinical operations team conducts phases I-IV clinical trials for pharmaceutical and biotech companies, maintaining the highest standards of ethics, quality and confidentiality. Our team of well-trained professionals has a collective experience of over 150 years in project management across various therapeutic areas.... Show more »

Syngene's clinical operations team conducts phases I-IV clinical trials for pharmaceutical and biotech companies, maintaining the highest standards of ethics, quality and confidentiality. Our team of well-trained professionals has a collective experience of over 150 years in project management across various therapeutic areas. This extensive experience has also helped us to successfully handle audits by our international clients as well as independent auditors.

We promote a team approach with emphasis on management, support, recognition, training, accountability and personal development. To provide quality monitoring services in compliance with the applicable regulatory guidelines, we conduct comprehensive training and development programs for our Clinical Research Associates (CRAs).

We offer the following clinical trial management services:

Project Management

All projects are efficiently handled by qualified project managers experienced in various therapeutic areas including oncology, endocrinology, gastroenterology, cardiovascular, dermatology, infectious diseases, neurology, immunology, orthopedics, respiratory, and metabolic disorders. We have extensive experience in Community based clinical studies and Observational studies.

Our project managers act as a single point of contact for sponsors throughout the duration of the study, ensuring quality deliverables within the timelines and budget. Project managers collaborate closely with medical monitors to address protocol-related queries and safety/clinical concerns thereby ensuring the integrity of clinical trial data. Project Managers also coordinate with Regulatory, CDM and Biometrics teams regarding regulatory approvals, Data cleaning/DB lock, Statistical Analysis and CSR.

Our project managers have adopted project management tools such as Enterprise Project Management (EPM) to effectively track the progress of the project and handle potential issues proactively.

Our project management team has successfully organized many investigators’ meetings, both in India and abroad.

Site management

Clinical Operations includes a dedicated Site feasibility team to perform pre sales feasibility and Site validation as part of study start up activity. Clinical operations team selects each study site based on the infrastructure and access to appropriate patient population. Syngene has a robust and extensive database of investigational sites which is developed by conducting detailed study feasibility assessment capable of identifying qualified Investigators and investigational sites with high degree of quality. Our database also provides information on the projected patient enrollment rates, competing clinical trials at the site, site personnel experience and training, site infrastructure, local IRB/IEC requirements and timelines.

After a thorough feasibility assessment our team tailors recruitment and retention plans unique to each site. Focusing on the site's strengths and experience. We have well-established relationships with hundreds of study sites across India and work closely with each site to develop successful recruitment and retention strategies.

Site management also covers up-gradation of site infrastructure to meet clinical trial requirements. We continually identify new investigators and train them to enrich the investigator database across different therapeutic areas. Our team also handles site finance management.

Clinical Trial Monitoring

Syngene’s CRAs, with a background in life sciences or medicine, are the main strength of the clinical operations department and add value for the timely execution of clinical projects. They have strong organizational skills, eye for detail, good written and oral communication skills and are trained in the ICH GCP guidelines and relevant national and international regulations. They travel to the study sites every four to six weeks or as per the sponsors’ monitoring SOP to ensure quality of data, protocol adherence and compliance with regulatory guidelines. CRAs undertake regular follow-up visits to study sites and provide weekly updates to both Clinical Project Managers and sponsor as needed. They also monitor drug dispensing procedures and drug accountability, conduct source data verification, data collection, safety reporting, informed consent form review and resolve data queries.

The team has a working knowledge of e-systems like Enterprise Project Management (EPM), Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), Interactive Voice Response Systems (IVRS) and Interactive Web Response Systems (IWRS).

Clinical Trial Supply Management

Syngene provides end-to-end management of clinical and ancillary supplies. We have extensive expertise in handling IRT modules like IVRS and IWRS. Our team develops a customized logistics model to meet the unique needs of the sponsor, while ensuring adherence to SOPs of Syngene/Sponsor and regulatory guidelines. Our service begins with providing assistance in obtaining import license and custom clearance of clinical supplies. Depending on the requirements of the sponsor, we also take the responsibility of drug destruction. We have dedicated pharmacists responsible for storage, handling, and accountability of clinical trial supplies and an enterprise resource program (ERP) to manage the inventories of all supplies.

Our facility has a separate 700 sq. ft. access-controlled, clinical supplies unit that maintains temperatures between -15 to -25°C, 15 to 25°C and 2 to 8°C. This unit has an electronic temperature monitoring system along with an auto alarm system.

To prevent degradation of clinical trial supplies, Syngene partners with reliable cold chain logistics solution providers to ship supplies in stable refrigerated conditions to the investigational sites.

Vendor Management

Syngene also provides vendor coordination and management as a key service based on sponsor requirements. Our clinical operations project managers serve as the single point of contact assuring uninterrupted communication and coordination with third parties.

We have established SOPs for coordinating with vendors and to monitor performance standards. Our Project Managers have set up complex logistics for Clinical studies by expert coordination with Vendors, which includes.

  • Translation Services
  • EDC/RDC Providers
  • IVRS Systems
  • IWRS Systems
  • Central Lab Services
  • Imaging Labs
  • Specialized diagnostic providers
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Bioinformatics

Price on request

At Syngene, we offer integrated bioinformatics services to biotech and pharmaceutical companies right across the drug discovery pipeline. Our bioinformatics services span the entire gamut from building data packages, pathway databases and knowledge bases, all the way to analysis of high throughput data, predictive modeling,... Show more »

At Syngene, we offer integrated bioinformatics services to biotech and pharmaceutical companies right across the drug discovery pipeline. Our bioinformatics services span the entire gamut from building data packages, pathway databases and knowledge bases, all the way to analysis of high throughput data, predictive modeling, mechanistic toxicology and systems biology.

Our highly experienced and skilled professional team of biologists, data scientists and informaticians is supported by software platforms such as Strand NGS, the Sarchictect Suite and the Virtual Liver technologies enabling us to provide scientific expertise and seamless delivery to our collaborators and making their research decisions more effective.

Our bioinformatics services can be accessed either in a standalone manner or as part of an integrated project that could include Syngene’s discovery biology, chemistry, clinical development or safety assessment capabilities.

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Biostatistical Analysis

Price on request

Syngene's Clinical Data Management and Biostatistics team provides solutions that are customized to meet the specific needs of each clinical study. Our systems, SOPs and project personnel are equipped to provide cost-effective and secure services. Based on previous experience of dealing with the complexities of global regulatory... Show more »

Syngene's Clinical Data Management and Biostatistics team provides solutions that are customized to meet the specific needs of each clinical study. Our systems, SOPs and project personnel are equipped to provide cost-effective and secure services. Based on previous experience of dealing with the complexities of global regulatory requirements, our project teams have developed the expertise to deliver projects on time while adhering to sponsor and protocol specific requirements.

Syngene's comprehensive disaster recovery plan is designed to keep its extensive information system intact and ensure continuity of research projects in the event of a disaster/adverse event.

Biostatistics:

  • Statistical inputs for protocol design
  • Sample size calculation
  • Randomization/blinding
  • SAS coding
  • Statistical analysis
  • Statistical report preparation
  • Support DSMB/DSRB conduct an interim analysis
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Biomarkers

Price on request

Clinical biomarkers offer objective measurements of biological processes to assist in the diagnosis and management of health conditions. During clinical trials, these measurements provide data to predict outcomes in terms of safety and efficacy. The utility of clinical biomarkers is often marred by the challenges of selecting... Show more »

Clinical biomarkers offer objective measurements of biological processes to assist in the diagnosis and management of health conditions. During clinical trials, these measurements provide data to predict outcomes in terms of safety and efficacy. The utility of clinical biomarkers is often marred by the challenges of selecting the right assay in an appropriate quality framework to obtain reliable, accurate and quality data for analysis.

Syngene offers a wide array of biomarkers across therapeutic areas to support clinical and epidemiological research. Equipped with a wide range of technology platforms, we provide clients optimized solutions to identify and set up biomarker assays in tissues, body fluids and cell based systems. In addition to helping clients select the right tool, Syngene ensures that assays are developed, validated and established under OECD-GLP certified or ISO15189 and College of American Pathologists (CAP) accredited quality systems to provide reliable and valid data. With over 10 years of experience in providing biomarker support to global clients, our experts provide scientific insight and add strategic value to your clinical drug development programs.

We have a strategic alliance with Pacific Biomarkers Inc. (PBI), a market leader in biomarkers for CVS, diabetes and metabolic disorders, to offer novel biomarker development and testing services to the global drug development community.

Syngene offers flexible solutions, supporting clients for both standalone biomarker assay requirements and also for biomarker requirements as a part of larger integrated clinical development programs. We offer the convenience of a single point of contact with our project management department with easy ’on demand’ accessibility to our scientific team to support client requirements.

Syngene’s Clinical Biomarker services include:

  • Assay development and validation services.
  • Establishing proof of concept.
  • Multiplatform validation services.
  • Establishment of assays at commercial scale.
  • Development of companion diagnostic tests.
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Adventitious Agent Testing

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In vitro Biosafety Testing

Price on request

Syngene provides viral testing and clearance services that caters to clients need for fulfilling the viral safety for their biologics programs. State-of-the-art BSL-2 laboratory at the viral testing facility has GMP compliant systems and assays to ensure that regulatory expectations are met for product filing and... Show more »

Syngene provides viral testing and clearance services that caters to clients need for fulfilling the viral safety for their biologics programs. State-of-the-art BSL-2 laboratory at the viral testing facility has GMP compliant systems and assays to ensure that regulatory expectations are met for product filing and licensing.

Key Features

  • Dedicated analytical lab and client suite for viral clearance studies
  • Dedicated suites for Real Time qPCR analyses
  • Well-equipped and segregated cell culture, viral testing, molecular and analytical laboratories
  • Traceability – receipt, storage and analysis of client samples
  • Document archival area with controlled access
  • Separate cell bank area for the storage of analytical cell lines
  • Bio-containment with pressure differential across the laboratories
  • Unit operations that can be handled are:
    • Inactivation: Low and High pH
    • Removal: Column Chromatography, Filtration

Services offered

Cell based in vitro testing of unprocessed bulk (CHO derived):

  • 14 and 28 day - adventitious virus detection using 3 lines: MRC – 5, Vero and CHO
  • Retrovirus detection using: Mus dunni and PG4 – S+L-

Virus Clearance Studies for Biologics (CHO derived):

Viral clearance studies evaluate the potential of downstream protein purification steps for the clearance of viruses. Syngene offers these studies for its customers’ manufacturing process where product have moved into clinical trials phase. This includes:

  • validation of process - removal, inactivation, or clearing of viruses in the product intermediates
  • Phase I submissions using 2 viruses MVM (Minute Virus of Mice) and MuLV (Murine Leukemia Virus)

Downstream Scale-down Model

  • Establishing the scale-down model based on the manufacturing scale process
  • For individual unit operations and their comparability with the manufacturing scale performance
  • For exploratory virus clearance steps
  • Typical in Phase 1 clearance with two or three downstream orthogonal steps (low pH/solvent-detergent, Chromatography step, Nano filtration)
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PBPK Modeling

In silico absorption, distribution, metabolism, and excretion
Price on request
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Clinical Data Management

Price on request

Syngene's Clinical Data Management and Biostatistics team provides solutions that are customized to meet the specific needs of each clinical study. Our systems, SOPs and project personnel are equipped to provide cost-effective and secure services. Based on previous experience of dealing with the complexities of global regulatory... Show more »

Syngene's Clinical Data Management and Biostatistics team provides solutions that are customized to meet the specific needs of each clinical study. Our systems, SOPs and project personnel are equipped to provide cost-effective and secure services. Based on previous experience of dealing with the complexities of global regulatory requirements, our project teams have developed the expertise to deliver projects on time while adhering to sponsor and protocol specific requirements.

Syngene's comprehensive disaster recovery plan is designed to keep its extensive information system intact and ensure continuity of research projects in the event of a disaster/adverse event.

Syngene offers CDMB services to support:

  • BA/BE studies
  • Phase I-IV clinical trials
  • CMC programs
  • Preclinical development (In vivo)

Data Management:

  • Case Report Forms (CRF) design
  • Workflow management
  • Data capture
  • Double data capture
  • Electronic data capture
  • Discrepancy/query management
  • Medical coding
  • Serious adverse event reconciliation
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In vitro Bioavailability/Bioequivalence Studies

Price on request
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Drug Preformulation

Price on request

The formulation development centre at Syngene offers a wide range of services for pre- formulation studies to support formulation and process development. Our scientists have the expertise to link the information generated at this stage to develop a quality product.

Our offerings include:

*Physico-Chemical... Show more »

The formulation development centre at Syngene offers a wide range of services for pre- formulation studies to support formulation and process development. Our scientists have the expertise to link the information generated at this stage to develop a quality product.

Our offerings include:

Physico-Chemical Characterization

  • pH- solubility profile and pKa determination
  • Solubility in various aqueous and non-aqueous vehicles
  • pH- stability profile
  • Intrinsic dissolution
  • Melting point
  • Hygroscopicity
  • Partition coefficient
  • Polymorph characterization studies

Powder Characteristics

  • Particle size distribution
  • True density and powder envelop density (powder, granules, roll compacted ribbons)
  • Bulk and tap density determination
  • Flow properties

Drug Excipient Compatibility Study

  • Binary or ternary mixtures of API with excipients from various functional categories such as diluents, binders, glidants, disintegrants, lubricants etc.
  • Packaging material compatibility studies
  • Selection of excipients for formulation development is based on the results of this study
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Polymer Characterization

Price on request

Our Polymer facility is well-equipped with analytical instruments such as GPC, DSC, FTIR, Viscometry, Brookfield viscometer, and NMR to analyse different kinds of polymers.

Our Polymer facility is well-equipped with analytical instruments such as GPC, DSC, FTIR, Viscometry, Brookfield viscometer, and NMR to analyse different kinds of polymers.

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Polymer Synthesis

Price on request

Syngene’s polymer group has expertise in the synthesis of anhydride, acrylate, lactide based bioPolymers, polyolefins, polysiloxanes conducting Polymers and various speciality Polymers. Our experts develop innovative ideas for synthesis of bioPolymers and speciality Polymers from gram to kilo scale.

Syngene’s polymer group has expertise in the synthesis of anhydride, acrylate, lactide based bioPolymers, polyolefins, polysiloxanes conducting Polymers and various speciality Polymers. Our experts develop innovative ideas for synthesis of bioPolymers and speciality Polymers from gram to kilo scale.

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DART Studies

Developmental and Reproductive Toxicology Studies
Price on request

Reproductive Toxicity

  • Male & female fertility study in rats
  • Prenatal, postnatal & maternal study in rats
  • Multi-generation (one/two) reproduction toxicity study in rats

Developmental Toxicity Studies

  • Teratology study in rats and rabbits

Neurotoxicity Studies (rats)

Reproductive Toxicity

  • Male & female fertility study in rats
  • Prenatal, postnatal & maternal study in rats
  • Multi-generation (one/two) reproduction toxicity study in rats

Developmental Toxicity Studies

  • Teratology study in rats and rabbits

Neurotoxicity Studies (rats)

  • Clinical observations
  • Functional observational battery (Modified Irwin's Test)
  • Neurobehavioral screening
  • Clinical observations
  • Motor activity
  • Learning and memory
  • Sensory evaluation
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Rabbit Rat Toxicology

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Toxicity Animal Models

Price on request

Acute Toxicity Studies

  • Single dose oral, dermal and parenteral toxicity studies in rats, mice and rabbits
  • Acute inhalation in rodents
  • Local tolerance studies
  • Skin irritation - rabbits
  • Mucous membrane irritation - rabbits
  • Guinea pig maximization studies

Sub-Acute Toxicity Studies

Acute Toxicity Studies

  • Single dose oral, dermal and parenteral toxicity studies in rats, mice and rabbits
  • Acute inhalation in rodents
  • Local tolerance studies
  • Skin irritation - rabbits
  • Mucous membrane irritation - rabbits
  • Guinea pig maximization studies

Sub-Acute Toxicity Studies

  • Repeat dose 7, 14, 21, 28 & 42 day studies

Sub-Chronic Toxicity Studies

  • Repeat dose 90 day studies

Chronic Toxicity Studies

  • Repeat dose 120 & 180 day studies
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Rabbit Guinea pig Mouse Rat

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Toxicology

Price on request

Syngene has proven experience to carry out a range of toxicology services to provide seamless integration between discovery and development programs.

General Toxicology study types include dose escalation studies, tolerability studies, and dose range finding studies.

Standard Species

Syngene has proven experience to carry out a range of toxicology services to provide seamless integration between discovery and development programs.

General Toxicology study types include dose escalation studies, tolerability studies, and dose range finding studies.

Standard Species

  • Rat
  • Mouse
  • Rabbit
  • Guinea Pig

Routes of Administration

  • Oral (gavage or dietary)
  • Intravenous
  • Intramuscular
  • Intraperitoneal
  • Subcutaneous
  • Dermal

Bioanalytical

We specialize in the development of bioanalytical methods to support Bioavailability and Pharmacokinetics studies. We provide both non-GLP and GLP bioanalytical services for both small and large molecules. The services include:

  • HPLC -UV and LC-MS/MS based methods and Elisa technology
  • Development of specialized Elisa Kits to meet project specific needs
  • Development of efficient extraction procedures (protein precipitation, liquid-liquid extraction, solid-phase extraction)
  • Development of analytical methods in the presence of different matrices (plasma, brain, liver, bile etc) and different species.
  • Immunogenicity and Neutralizing Antibody analysis.

Toxicokinetics

  • In vivo Toxicokinetics (Rats & Mice)
  • Dosing of animals
  • Collection and processing of samples

Clinical Chemistry and Histopathology

Syngene has the state-of-the-art facility to provide a broad based analysis of a variety of parameters in each of the following categories:

  • Hematological analysis
  • Clinical chemistry analysis
  • Urinalysis
  • Gross pathology services
  • Histopathology services:
    • Routine and special histochemical staining
    • Immunohistochemistry techniques
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Pharmaceutical Manufacturing

Price on request

Syngene provides manufacturing services of high potent compounds in oncology therapeutic area which represents one of the fastest growing segments of the pharmaceutical and biotechnology industry as well as for other therapeutic applications. This exclusive facility has capabilities to handle compounds up to an OEL limit of <... Show more »

Syngene provides manufacturing services of high potent compounds in oncology therapeutic area which represents one of the fastest growing segments of the pharmaceutical and biotechnology industry as well as for other therapeutic applications. This exclusive facility has capabilities to handle compounds up to an OEL limit of < 0.1μg/ m3-8h (TWA). A team of highly qualified and experienced technicians operate the facilities in compliance with all safety and regulatory requirements. All necessary support functions like safety, EHS and maintenance are available on site. Strong emphasis is given to maintaining the quality as well as ensuring the safety of man and material at every stage.

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Manufacturing Services

Price on request

Syngene has exclusive capabilities for manufacturing from bench top volume to commercial scale and is also further expanding to cater to the growing demands. Depending on the end application, the manufacturing is done in an appropriate facility at Syngene. Our uncompromised commitment to safety and regulatory compliance helped Syngene to be the trusted partner for several global customers.

Syngene has exclusive capabilities for manufacturing from bench top volume to commercial scale and is also further expanding to cater to the growing demands. Depending on the end application, the manufacturing is done in an appropriate facility at Syngene. Our uncompromised commitment to safety and regulatory compliance helped Syngene to be the trusted partner for several global customers.

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Technology Transfer and Licensing

Price on request

The objective of the tech transfer exercise is to ensure a unidirectional process from lab to manufacturing facilities. This is ensured by collecting data around scalability, robustness and sustainability of the developed processes in the lab stage as well as at the tech transfer stage. Syngene is equipped to simulate the heat and... Show more »

The objective of the tech transfer exercise is to ensure a unidirectional process from lab to manufacturing facilities. This is ensured by collecting data around scalability, robustness and sustainability of the developed processes in the lab stage as well as at the tech transfer stage. Syngene is equipped to simulate the heat and mass transfer conditions experienced in the manufacturing scale at the laboratory stage itself with appropriate instrumentation including automated glass reactors. With such facilities and expertise, Syngene is well equipped to anticipate the difficulties and challenges (potential show stoppers) in the manufacturing plant well ahead of the actual scale up. As part of our complete end-to-end solution, we offer a systematic, tried and tested approach to tech transfer. We believe the ultimate success of a tech transfer is to ensure safe scale-up of processes with consistent quality.

We are proficient in developing a robust process right from laboratory to manufacturing scale. Syngene has created many “right first time technology transfer success stories of an in-house developed process and customer processes” and this has been considered as one of our key strengths and differentiator.

We have a well-established technology transfer framework, which ensures rigorous process understanding before transfer and supported by the best documentation practices.

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Process and Scale-Up Chemistry

Price on request

Syngene‘s chemical process design and development team comprise of 250+ scientists. The team has the skill sets and experience to meet a wide range of scientific requirements, including route scouting, chemical process optimization, chemical process familiarization, feasibility studies and scale up to support the development... Show more »

Syngene‘s chemical process design and development team comprise of 250+ scientists. The team has the skill sets and experience to meet a wide range of scientific requirements, including route scouting, chemical process optimization, chemical process familiarization, feasibility studies and scale up to support the development continuum. Working in state-of-the-art laboratories, equipped with high end Process Research & Development (PRD) tools such as QbD and PAT techniques, our scientists efficiently carry out studies for the different phases of product development. Contribution of our scientists is not only in the quick delivery of the project, but also advising our clients on synthetic methodology tools and development approach, based on scientific rationale. Our team follows phase appropriate – fit to purpose development approach.

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Viral Clearance Assays

Price on request

Syngene provides viral testing and clearance services that caters to clients need for fulfilling the viral safety for their biologics programs. State-of-the-art BSL-2 laboratory at the viral testing facility has GMP compliant systems and assays to ensure that regulatory expectations are met for product filing and... Show more »

Syngene provides viral testing and clearance services that caters to clients need for fulfilling the viral safety for their biologics programs. State-of-the-art BSL-2 laboratory at the viral testing facility has GMP compliant systems and assays to ensure that regulatory expectations are met for product filing and licensing.

Key Features

  • Dedicated analytical lab and client suite for viral clearance studies
  • Dedicated suites for Real Time qPCR analyses
  • Well-equipped and segregated cell culture, viral testing, molecular and analytical laboratories
  • Traceability – receipt, storage and analysis of client samples
  • Document archival area with controlled access
  • Separate cell bank area for the storage of analytical cell lines
  • Bio-containment with pressure differential across the laboratories
  • Unit operations that can be handled are:
    • Inactivation: Low and High pH
    • Removal: Column Chromatography, Filtration

Services offered

Cell based in vitro testing of unprocessed bulk (CHO derived):

  • 14 and 28 day - adventitious virus detection using 3 lines: MRC – 5, Vero and CHO
  • Retrovirus detection using: Mus dunni and PG4 – S+L-

Virus Clearance Studies for Biologics (CHO derived):

Viral clearance studies evaluate the potential of downstream protein purification steps for the clearance of viruses. Syngene offers these studies for its customers’ manufacturing process where product have moved into clinical trials phase. This includes:

  • validation of process - removal, inactivation, or clearing of viruses in the product intermediates
  • Phase I submissions using 2 viruses MVM (Minute Virus of Mice) and MuLV (Murine Leukemia Virus)

Downstream Scale-down Model

  • Establishing the scale-down model based on the manufacturing scale process
  • For individual unit operations and their comparability with the manufacturing scale performance
  • For exploratory virus clearance steps
  • Typical in Phase 1 clearance with two or three downstream orthogonal steps (low pH/solvent-detergent, Chromatography step, Nano filtration)

We provide resin recycling studies and comparative virus clearance capability of the used resin with naïve chromatographic resin.

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Biopharmaceutical Development

Price on request

Syngene is highly proficient in developing biosimilar processes as well as conducting biosimilarity assessment and biosimilar characterization. Members of our team have helped launch several biosimilar products in regulated and semi-regulated markets. We have conducted extensive biosimilarity characterization for products made by... Show more »

Syngene is highly proficient in developing biosimilar processes as well as conducting biosimilarity assessment and biosimilar characterization. Members of our team have helped launch several biosimilar products in regulated and semi-regulated markets. We have conducted extensive biosimilarity characterization for products made by clients from the US as well as India, and have excellent systems developed to conduct product characterization and method validation.

All quality control testing, starting with raw material testing, in-process testing to finished product testing, environmental and water quality monitoring, microbiological testing, and product lot release and stability testing is carried out in-house in compliance with global GMP standards.

Biosimilar services include

  • Cell line development
  • Drug Substance and Drug Product process development
  • Basic biosimilar characterization package
  • Advanced biosimilar characterization package
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Product Stability Testing

Price on request

We routinely conduct exploratory, freeze-thaw, long-term storage, accelerated and stress (forced degradation) stability studies. We offer both non-GMP and GMP stability studies of drug substance and drug product. GMP stability studies are conducted under Syngene-QA approved protocols.

Stability studies services... Show more »

We routinely conduct exploratory, freeze-thaw, long-term storage, accelerated and stress (forced degradation) stability studies. We offer both non-GMP and GMP stability studies of drug substance and drug product. GMP stability studies are conducted under Syngene-QA approved protocols.

Stability studies services include:

  • Freeze thaw studies
  • Long term and accelerated studies
  • Forced degradation studies
  • Photostability, shear stress and other stress stability studies
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Pharmaceutical Formulation

Price on request

We offer formulation development for early stage formulation as well as commercial drug drug product. We have extensive experience in NBE formulation development. Our services services include development of both liquid and lyophilized presentations. Parallel studies of prototypes are conducted to reduce time lines.

Our... Show more »

We offer formulation development for early stage formulation as well as commercial drug drug product. We have extensive experience in NBE formulation development. Our services services include development of both liquid and lyophilized presentations. Parallel studies of prototypes are conducted to reduce time lines.

Our services include pre-formulation services along with formulation process development development and compatibility studies with administration components. Parallel studies of prototypes conducted to reduce time lines.

Stand-alone services offered are:

  • Pre-formulation studies for development of drug product composition
  • Process development including lyophilization cycle development and optimization
  • Scale-up and technology transfer support
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Process Consulting

Price on request

Competent approach with advanced technologies and precise process controls ensure the significant enhancement of protein expression. Our process development is always geared towards obtaining desired growth, productivity and purity. High throughput screening of upstream parameters and downstream unit operations are followed to... Show more »

Competent approach with advanced technologies and precise process controls ensure the significant enhancement of protein expression. Our process development is always geared towards obtaining desired growth, productivity and purity. High throughput screening of upstream parameters and downstream unit operations are followed to reduce time lines.

Achieving the desired results with compressing time lines and reduced costs for the development is a key offering by Syngene. We assure that process developed at Syngene is rapidly translated into a robust, scalable and economical process suitable to be transferred to GMP and validated.

The step wise approach taken during process development is briefly mentioned below:

Upstream process development

  • Bioreactor evaluation of the selected clones
  • Culture conditions identification and improvement
  • Feeding regime optimization
  • Design of Experiments (DOE) and process modelling approaches at different stages of development
  • Process troubleshooting for quality, yield and robustness
  • Support for scale-up to plant bioreactor scale

Downstream process development

  • Single/multiple unit operation development and optimization
  • FMEA for CQA in a given unit operation
  • Process scaled-down model and qualification
  • Process characterization (statistical approach) and validation studies
  • TTD preparation and Process transfer to other manufacturing sites
  • Support for process scale-up to bioreactor scale
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ChIP-Seq

Chromatin Immunoprecipitation Sequencing
Price on request
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Transcriptome Sequencing and Profiling

Price on request
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Exome Sequencing Services

Price on request
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Targeted Resequencing

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Whole Genome Sequencing

Price on request
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Liver Fibrosis Animal Models

Price on request
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Wound Healing Animal Models

Price on request
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Bioanalysis

Price on request

Development of bioanalytical methods to support bioavailability and pharmacokinetics studies.

  • HPLC -UV and LC-MS/MS based methods
  • Development of efficient extraction procedures (protein precipitation, liquid- liquid extraction, solid-phase extraction)
  • Development of analytical methods in presence of different matrices

Development of bioanalytical methods to support bioavailability and pharmacokinetics studies.

  • HPLC -UV and LC-MS/MS based methods
  • Development of efficient extraction procedures (protein precipitation, liquid- liquid extraction, solid-phase extraction)
  • Development of analytical methods in presence of different matrices
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Osteoarthritis Animal Models

Price on request
  • Medial Meniscal Tear (Rat)
  • Anterior Cruciate Ligament Transection (ACLT) (Rat)
  • ACLT + Partial Medial Meniscotomy (Rat)
  • Spontaneous Osteoarthritis (G. Pigs)
  • Medial Meniscal Tear (Rat)
  • Anterior Cruciate Ligament Transection (ACLT) (Rat)
  • ACLT + Partial Medial Meniscotomy (Rat)
  • Spontaneous Osteoarthritis (G. Pigs)
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Analytical Chemistry Services

Price on request

Syngene’s Discovery Analytical Chemistry provides analytical and separation services to discovery chemistry team and for stand-alone projects. Our analytical facility has got full range of state-of-the-art instruments.

Expertise

  • Strategic collaboration with a US Large Pharma.
  • High-throughput synthesis of peptide... Show more »

Syngene’s Discovery Analytical Chemistry provides analytical and separation services to discovery chemistry team and for stand-alone projects. Our analytical facility has got full range of state-of-the-art instruments.

Expertise

  • Strategic collaboration with a US Large Pharma.
  • High-throughput synthesis of peptide libraries.
  • Solid-phase Peptide synthesis on Automated synthesizer – up to 48 peptides at a time.
  • Synthesis of high-quality peptides within the predefined timelines.
  • Method development using HPLC, GC, UPLC-MS, LC-MS and GC-MS
  • Chiral and achiral separation using SFC and preparative HPLC from milligrams to multi-hundred grams scale
  • Residual solvent analysis
  • Structural elucidation using LC-MS & NMR
  • High-throughput purification of library compounds
  • Trace analysis and detection of impurity up to 0.01% for OLED compounds
  • Capability to separate multiple kilograms
  • Impurity isolation and Characterization studies
  • Non-carry over studies for the API molecules

Infrastructure

  • HPLC (DAD, RID, ELSD, CAD & VWD)
  • Preparative HPLC (UV, DAD, MS & ELSD)
  • UPLC-MS
  • GC (FID & TCD)/GCMS (Purge & trap and Headspace)
  • LCMS (Single quad, Ion trap & Q-TOF)
  • SFC ( Analytical SFC-MS & Preparative SFC-UV )
  • GPC (VWD & RI) and Recycling preparative GPC
  • NMR (300 & 400 MHz)
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Autoimmune Disease Animal Models

Price on request
  • Arthritis - Collagen induced arthritis (CIA) (Rat & Mouse), Adjuvant induced arthritis (AIA) (Rat)
  • Psoriasis – TPA induced epidermal hyperplasia (Mouse), Human Psoriatic Skin Transplanted SCID (Mouse)
  • Colitis – Dextran Sulphate Sodium (DSS) Induced (Ulcerative Colitis) (Mouse), Trinitrobenzene Sulphonate (TNBS) Induced... Show more »
  • Arthritis - Collagen induced arthritis (CIA) (Rat & Mouse), Adjuvant induced arthritis (AIA) (Rat)
  • Psoriasis – TPA induced epidermal hyperplasia (Mouse), Human Psoriatic Skin Transplanted SCID (Mouse)
  • Colitis – Dextran Sulphate Sodium (DSS) Induced (Ulcerative Colitis) (Mouse), Trinitrobenzene Sulphonate (TNBS) Induced (Chron's Disease) (Rat & Mouse)
  • Multiple Sclerosis - Experimental Autoimmune Encephalitis (EAE), Chronic Progressive & Relapsing Remitting Models (Mouse)
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Custom Pain Animal Models

Price on request
  • Chemically Induced Nociception - Acetic acid induced writhing (Rat), Formalin induced tonic pain (Rat & Mouse)
  • Neuropathic Pain - Partial sciatic nerve ligation (PSNL) (Rat), chronic constriction injury (CCI) (Rat), Spinal Nerve Ligation (SNL) (Rat)
  • Inflammatory Pain - Adjuvant (CFA) induced pain
  • Chemically Induced Nociception - Acetic acid induced writhing (Rat), Formalin induced tonic pain (Rat & Mouse)
  • Neuropathic Pain - Partial sciatic nerve ligation (PSNL) (Rat), chronic constriction injury (CCI) (Rat), Spinal Nerve Ligation (SNL) (Rat)
  • Inflammatory Pain - Adjuvant (CFA) induced pain
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Inflammation Animal Models

Price on request
  • Acute – LPS induced pulmonary inflammation (Rat), Carrageenan induced paw edema (Rat & Mouse), Cytokine Induced Inflammation (Rat & Mouse)
  • Chronic – Carrageenan Airpouch inflammation (Rat), Cotton Pellet Induced Granuloma (Rat), Bleomycin Induced Pulmonary Fibrosis (Rat)
  • Acute – LPS induced pulmonary inflammation (Rat), Carrageenan induced paw edema (Rat & Mouse), Cytokine Induced Inflammation (Rat & Mouse)
  • Chronic – Carrageenan Airpouch inflammation (Rat), Cotton Pellet Induced Granuloma (Rat), Bleomycin Induced Pulmonary Fibrosis (Rat)
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Metabolic Animal Models

Price on request
  • Genetic Models – Zucker Obese Rat (Zucker fa/fa), db/db mice and Zucker Diabetic Fatty (ZDF)
  • Diet Induced - Obesity using C57BL/6 Mice (DIO)
  • STZ Induced - Streptozotocin + Nicotinmide model for T2DM and Streptozotocin Induced T1DM
  • Genetic Models – Zucker Obese Rat (Zucker fa/fa), db/db mice and Zucker Diabetic Fatty (ZDF)
  • Diet Induced - Obesity using C57BL/6 Mice (DIO)
  • STZ Induced - Streptozotocin + Nicotinmide model for T2DM and Streptozotocin Induced T1DM
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Oncology Animal Models

Price on request
  • Subcutaneous tumor xenograft model
  • Orthotopic xenograft model
  • Metastasis models
  • Subcutaneous tumor xenograft model
  • Orthotopic xenograft model
  • Metastasis models
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In vivo Pharmacology Studies

Price on request

Early stage PK evaluation of NCE's in rodents:

  • Discrete and cassette dosing
  • Tissue distribution
  • Brain-plasma distribution
  • Entero-hepatic recirculation (EHC)
  • Determination of fundamental PK parameters (Tmax, Cmax, AUC, clearance, oral bioavailability, volume of distribution, etc.)

Early stage PK evaluation of NCE's in rodents:

  • Discrete and cassette dosing
  • Tissue distribution
  • Brain-plasma distribution
  • Entero-hepatic recirculation (EHC)
  • Determination of fundamental PK parameters (Tmax, Cmax, AUC, clearance, oral bioavailability, volume of distribution, etc.)
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In vitro ADME/DMPK Studies

Price on request
  • Physico-chemical properties - aqueous solubility, pH stability, Lipophilicity (Log D) and Log P
  • Absorption – PAMPA, CaCo-2 and MDCK, Efflux (CaCo-2)
  • Metabolism & stability - Liver microsomes (%PCR and Clint), plasma and serum stability, CYP450 inhibition includes inhibition screening (Fluorescence based/LC-MS/MS based) and... Show more »
  • Physico-chemical properties - aqueous solubility, pH stability, Lipophilicity (Log D) and Log P
  • Absorption – PAMPA, CaCo-2 and MDCK, Efflux (CaCo-2)
  • Metabolism & stability - Liver microsomes (%PCR and Clint), plasma and serum stability, CYP450 inhibition includes inhibition screening (Fluorescence based/LC-MS/MS based) and time - dependent inhibition (TDI), CYP450 phenotyping and metabolite identification (LC-MS/MS) (in vitro & in vivo)
  • Distribution - plasma protein binding, brain protein binding and blood-plasma distribution (Ce/Cp)
  • Cytotoxicity - cell-based assays in human cell- lines
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Cell-Based Assays

Price on request
  • Proliferation (Tetrazolium based/ Alamar blue/ [3H]-Thymidine incorporation)
  • Death (Cytotoxicity)
    • Apoptosis (Caspase 3 & 8, DNA laddering)
    • Necrosis (Calcein AM, Trypan blue exclusion, ATP depletion, LDH release)
  • Receptor binding/ uptake (SPA in flash plates)
  • Metabolism and protein turnover (labelled amino acid... Show more »
  • Proliferation (Tetrazolium based/ Alamar blue/ [3H]-Thymidine incorporation)
  • Death (Cytotoxicity)
    • Apoptosis (Caspase 3 & 8, DNA laddering)
    • Necrosis (Calcein AM, Trypan blue exclusion, ATP depletion, LDH release)
  • Receptor binding/ uptake (SPA in flash plates)
  • Metabolism and protein turnover (labelled amino acid incorporation in SPA)
  • Signalling & second messenger generation (cAMP/cGMP/Ca2+efflux)
  • Phosphorylation (CELISA)
  • Reporter gene (Luminescence, GFP and ß-Gal)
  • Chemokine/ Cytokine release (ELISA)
  • Cis/trans activation (NFkb activation)
  • Ion channel (patch clamp assays)
  • GPCRs (Functional and whole-cell ligand binding assays)
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Assay Development

Price on request
  • Adaptation for higher plate format (384 and above)
  • Assay compatibility with DMSO
  • Z- factor
  • Validation with reference compounds
  • Rank order potency and IC50 determination
  • Kinetics (Type of inhibition, inhibition constant determination)
  • Homogeneous assays for rapid screening
  • Adaptation for higher plate format (384 and above)
  • Assay compatibility with DMSO
  • Z- factor
  • Validation with reference compounds
  • Rank order potency and IC50 determination
  • Kinetics (Type of inhibition, inhibition constant determination)
  • Homogeneous assays for rapid screening
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Monoclonal Antibody (mAb) Production

Price on request
  • Cloning of antibody genes from hybridoma and generation of high-expressing plasmid constructs
  • Transient transfections (in HEK293) and/ or stable cell line generation (in CHO-based expression systems)
  • Production from small scale to large scale bioreactor cultures
  • Purification of antibodies
  • Analytical/ biochemical... Show more »
  • Cloning of antibody genes from hybridoma and generation of high-expressing plasmid constructs
  • Transient transfections (in HEK293) and/ or stable cell line generation (in CHO-based expression systems)
  • Production from small scale to large scale bioreactor cultures
  • Purification of antibodies
  • Analytical/ biochemical characterization by various methods including Surface Plasmon Resonance (BIAcore)
  • Cell banking and quality control
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Hybridoma Production

Price on request
  • Conjugation for immunization
  • Immunization of mice/rat
  • Animal care & handling
  • Titer determination
  • Hybridoma generation and screening by ELISA and BIAcore
  • Screening for biological attributes (such as neutralization, internalization etc.)
  • Subcloning and isotyping of selected clones
  • Purification and analysis of monoclonal antibodies
  • Cryopreservation of cell lines
  • Conjugation for immunization
  • Immunization of mice/rat
  • Animal care & handling
  • Titer determination
  • Hybridoma generation and screening by ELISA and BIAcore
  • Screening for biological attributes (such as neutralization, internalization etc.)
  • Subcloning and isotyping of selected clones
  • Purification and analysis of monoclonal antibodies
  • Cryopreservation of cell lines
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Polyclonal Antibody Production

Price on request
  • Generation of polyclonal antibodies – New Zealand White Rabbit standard or custom protocols
  • Variety of antigens (bacterial, fusion proteins & synthetic peptides)
  • Purification using affinity matrices (Protein A & Protein G)
  • Generation of polyclonal antibodies – New Zealand White Rabbit standard or custom protocols
  • Variety of antigens (bacterial, fusion proteins & synthetic peptides)
  • Purification using affinity matrices (Protein A & Protein G)
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Cell Line Generation

Price on request

Syngene can generate homogenous stable clones in different cellular backgrounds including very hard-to-transfect cell lines and primary cells, for expressing genes of interest at high levels for reagent generation, assay development and biotherapeutic development.

We specialize in the over-expression of tagged and untagged... Show more »

Syngene can generate homogenous stable clones in different cellular backgrounds including very hard-to-transfect cell lines and primary cells, for expressing genes of interest at high levels for reagent generation, assay development and biotherapeutic development.

We specialize in the over-expression of tagged and untagged proteins; G-protein coupled receptors receptor/ ligand, Ion channels, micro RNA target genes, transcription factors and reporter genes. The activities include cell transfections for generation of recombinant cell lines, optimization of transfection, serum free adaptation, media optimization, cell line characterization, monoclonal antibody production and research cell banking.

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Flow Cytometry

Price on request
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Protein Characterization

Price on request

A myriad of techniques are employed to analyse each batch of protein produced that ensures strict quality control and minimal batch to batch variation:

  • Electrophoresis (SDS-PAGE, native-PAGE)
  • Capillary Gel Electrophoresis (CGE)
  • DOT/Western blot
  • Imaging Capillary Electrophoresis (iCE)
  • Mass Spectrometry (ESI-MS/MS,... Show more »

A myriad of techniques are employed to analyse each batch of protein produced that ensures strict quality control and minimal batch to batch variation:

  • Electrophoresis (SDS-PAGE, native-PAGE)
  • Capillary Gel Electrophoresis (CGE)
  • DOT/Western blot
  • Imaging Capillary Electrophoresis (iCE)
  • Mass Spectrometry (ESI-MS/MS, MALDI-TOF/TOF)
  • Peptide Mass Finder Printing
  • Reverse Phase-HPLC
  • Size Exclusion HPLC
  • Glycoform Analysis
  • Endotoxin Level Detection
  • Biological Activity Assays
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ELISA

Enzyme-linked immunosorbent assay
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Protein Purification

Price on request
  • Use of state-of-the-art chromatography systems (Akta)
  • Purification of mg to gram quantities of proteins for various applications (research, assay, animal studies, crystallography)
  • Development and optimization of purification strategy using multiple steps of chromatographic methods:
  • Use of state-of-the-art chromatography systems (Akta)
  • Purification of mg to gram quantities of proteins for various applications (research, assay, animal studies, crystallography)
  • Development and optimization of purification strategy using multiple steps of chromatographic methods:
    • Affinity
    • Hydrophobic
    • Ion exchange
    • Size exclusion
  • Purification of recombinant proteins containing designed purification tags : His6, GST, MBP, SUMO, FLAG, etc.
  • Option of tag removal by proteolytic digestion (Thrombin, TEV, PreScission, SUMO protease, Factor Xa, etc.)
  • Purification from inclusion bodies:
    • Development of refolding methods by exhaustive screening of refolding conditions
    • Refolding scale up and purification of properly folded protein
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RT-PCR

Reverse transcription polymerase chain reaction
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Recombinant Protein Expression

Price on request

Expression in Bacteria

  • Bacterial hosts such as E.coli, Bacillus
  • Expression screening in E.coli to identify suitable host strain and optimal conditions for expression
  • Scale of expression: 2 - 10 L lab scale and 20 - 225L pilot scale

Expression in Yeast

  • Hosts such as Saccharomyces sp. and Pichia pastoris
    -... Show more »

Expression in Bacteria

  • Bacterial hosts such as E.coli, Bacillus
  • Expression screening in E.coli to identify suitable host strain and optimal conditions for expression
  • Scale of expression: 2 - 10 L lab scale and 20 - 225L pilot scale

Expression in Yeast

  • Hosts such as Saccharomyces sp. and Pichia pastoris
  • Expression screening to identify suitable host strain and optimal conditions for expression
  • Scale of expression: 2 - 10 L lab scale and 20 - 225 L pilot scale

Expression in Insect cells

  • Insect Cell Lines used: Sf9, Sf21, High Five
  • Generation of high titer recombinant baculovirus
  • MOI studies
  • Scale of expression: 2 to 50L in Wave Bioreactor

Expression in mammalian cells

  • Mammalian Cell lines: CHO-K1, HEK 293, CHO-S, CHO-DG44 etc.
  • Transient transfection for expression and purification of proteins
  • Generation of stable cell lines expressing recombinant proteins
  • Scale of expression: 2 - 10 L lab scale and 30 - 300 L pilot scale
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Northern Blot

Price on request
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Mass Spectrometry

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In vitro Reporter Gene Assays

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Western Blot

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Microbial Strain Development

Price on request

We have experience in engineering bacterial and yeast host strains for the improved production of recombinant products and to introduce new catabolic activities.

  • Strain modification methods: We provide site directed mutagenesis, gene knock out and insertional inactivation.
  • Analysis of engineered strains: We have expertise... Show more »

We have experience in engineering bacterial and yeast host strains for the improved production of recombinant products and to introduce new catabolic activities.

  • Strain modification methods: We provide site directed mutagenesis, gene knock out and insertional inactivation.
  • Analysis of engineered strains: We have expertise in molecular methods, microbiological methods and productivity analysis.
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Yeast Strain Construction and Optimization

Price on request

We have experience in engineering bacterial and yeast host strains for the improved production of recombinant products and to introduce new catabolic activities.

  • Strain modification methods: We provide site directed mutagenesis, gene knock out and insertional inactivation.
  • Analysis of engineered strains: We have expertise... Show more »

We have experience in engineering bacterial and yeast host strains for the improved production of recombinant products and to introduce new catabolic activities.

  • Strain modification methods: We provide site directed mutagenesis, gene knock out and insertional inactivation.
  • Analysis of engineered strains: We have expertise in molecular methods, microbiological methods and productivity analysis.
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Peptide Synthesis

Price on request

Syngene’s peptide synthesis group is specialised in the synthesis of various type of peptides from few mg to a gram scale. Our state-of-the-art labs are equipped with many automated peptides synthesisers and other supporting equipment.

Highlights

  • Strategic collaboration with a US Large Pharma.
  • High-throughput... Show more »

Syngene’s peptide synthesis group is specialised in the synthesis of various type of peptides from few mg to a gram scale. Our state-of-the-art labs are equipped with many automated peptides synthesisers and other supporting equipment.

Highlights

  • Strategic collaboration with a US Large Pharma.
  • High-throughput synthesis of peptide libraries.
  • Solid-phase Peptide synthesis on Automated synthesizer – up to 48 peptides at a time.
  • Synthesis of high-quality peptides within the predefined timelines.

Expertise

  • Linear peptides up to 50-mer.
  • Cysteine rich & disulfide bridged Peptides.
  • Peptide Derivatives and Labelling with PEG, Biotin, FITC, FAM etc.
  • Conformational constrained peptides.
  • Branched Chain petides
  • Cyclic peptides
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Compound Library Synthesis

Price on request

Syngene provides library design and synthesis services with a solid track record of delivering library sets independently or in collaboration with clients in Pharmaceutical, Agrochemical, Animal Health and allied industries.

Syngene provides library design and synthesis services with a solid track record of delivering library sets independently or in collaboration with clients in Pharmaceutical, Agrochemical, Animal Health and allied industries.

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Recombinant DNA Technology

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We provide Recombinant DNA engineering services in the following areas:

  • Gene Cloning & Vector Construction: Gene cloning by various methods such as High Throughput Recombination based Cloning - Gateway Technology, De Novo Cloning (PCR / Degenerate PCR/RT-PCR/Homology based PCR, etc.), Synthetic genes, Oligo – Linker Cloning,... Show more »

We provide Recombinant DNA engineering services in the following areas:

  • Gene Cloning & Vector Construction: Gene cloning by various methods such as High Throughput Recombination based Cloning - Gateway Technology, De Novo Cloning (PCR / Degenerate PCR/RT-PCR/Homology based PCR, etc.), Synthetic genes, Oligo – Linker Cloning, Sub-cloning and RACE In addition to gene cloning, vector construction can also be carried out for generating tailor made vectors for specific purposes.
  • Mutagenesis: Types of mutations which we do are Point mutation, Insertion, Deletion or Replacement. Each mutagenesis is customized to meet specific client requirements such as Random Mutagenesis (Error prone PCR) and Site-directed mutagenesis (Dpn I restriction enzyme based, Splicing by Overlapping Extension (SOE) PCR and Megaprimer based).
  • Genome Walking: We have expertise in carrying out genome walking to identify unknown sequences flanking the known gene sequences such as Conventional (Bacterial/Phage Library screening) and PCR based methods.
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Chemical Synthesis

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Syngene’s Synthetic Chemistry division offers a broad spectrum of services in diverse areas of chemistry. Our team of highly accomplished scientists, in collaboration with our clients, work towards meeting the objective of client’s project using the most efficient route for synthesis. Our scientists have expertise in key areas of... Show more »

Syngene’s Synthetic Chemistry division offers a broad spectrum of services in diverse areas of chemistry. Our team of highly accomplished scientists, in collaboration with our clients, work towards meeting the objective of client’s project using the most efficient route for synthesis. Our scientists have expertise in key areas of chemistry; such as asymmetric synthesis, organometallic chemistry, library synthesis, natural product analogs, peptides, nucleosides, carbohydrate chemistry etc. Our team delivers time-sensitive, cost-effective, process friendly solutions to our customers.

Highlights:

  • Successful completion of a large number of diverse projects from many clients from varied (Pharma/Agro/Biotech/Electronic) industry around the globe over the past two decades.
  • State-of–the-art facilities coupled with fully integrated automated purification capabilities.
  • Expertise:A dedicated custom synthesis group comprising over 100 scientists and more than a dozen PhDs to support the Fee-For-Service (FFS) model that comfortably accommodates stringent timelines and delivery of quality products.
  • Highly responsive to modifications in overall synthetic strategy.
  • Scientists trained to use client provided electronic note books thereby providing client access to the progress of the project on real time basis.
  • Effective and proactive communication, detailed updates provided to partner scientists at client’s site using multiple channels (email, teleconference and video conferences).
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gram milligram kilogram

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Hit to Lead and Lead Optimization

Price on request
  • Analysis of hits for potency, selectivity and drug-likeness.
  • Hit expansion with support from high-throughput synthesis.
  • Design of novel analogues with the help of conventional and computational chemistry methods and early ADME properties.
  • Route scouting and synthesis of focused library of compounds.
  • In vitro and In... Show more »
  • Analysis of hits for potency, selectivity and drug-likeness.
  • Hit expansion with support from high-throughput synthesis.
  • Design of novel analogues with the help of conventional and computational chemistry methods and early ADME properties.
  • Route scouting and synthesis of focused library of compounds.
  • In vitro and In vivo screening of compounds for optimization.
  • Design hypothesis to optimize the hits
  • Optimization of leads via multi-parameter optimization approach.
  • Optimization for potency, selectivity, In vivo efficacy, PK/PD profile, safety and toxicity profile.
  • Early scale up of molecules to support In vivo efficacy and toxicity studies.
  • Preclinical candidate selection.
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Computational Chemistry

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The Computational Chemistry capability at Syngene works closely with the medicinal chemists and the discovery project team to support medicinal chemistry projects in hit generation, hit-lead and lead optimizations. We routinely apply various computational methods and techniques e.g., protein modelling, molecular docking, Structure... Show more »

The Computational Chemistry capability at Syngene works closely with the medicinal chemists and the discovery project team to support medicinal chemistry projects in hit generation, hit-lead and lead optimizations. We routinely apply various computational methods and techniques e.g., protein modelling, molecular docking, Structure Based Drug Design (SBDD), Fragment Based Drug Design (FBDD), Ligand Based Drug Design (LBDD), pharmacophore modelling, scaffold hopping, focused library design, QSAR model building and physicochemical property calculations. The computational chemistry services are available as a part of integrated drug discovery services or as a stand-alone services.

Highlights

  • Structure based modelling services - homology modelling and docking.
  • Ligand based modelling services - pharmacophore modelling and ligand alignments.
  • Scaffold hopping and de novo designs for new novel series.
  • Fragment based designs.
  • Druggability analysis, virtual screening and HTS triage.
  • Library design: Target based or diversity based.
  • Cheminformatics based services to support similarity, diversity and cluster analysis, QSAR and QSPR.
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Flow Chemistry

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The major advantages of flow chemistry are faster reactions, cleaner products, safer reactions, quick reaction optimization, easy scale-up, and the integration of typically separate processes (such as synthesis, work-up, and analysis).

The major advantages of flow chemistry are faster reactions, cleaner products, safer reactions, quick reaction optimization, easy scale-up, and the integration of typically separate processes (such as synthesis, work-up, and analysis).

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E Series Easy MedChem Flow System UV-150 Photochemical Flow Reactor

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Literature Review/Curation

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Fluorescence Activated Cell Sorting (FACS)

Fluorescence Activated Cell Sorting
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Primer Extension Assay

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PCR

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DNA Extraction and Purification

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DNA Sequencing

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We are equipped with capabilities for both NGS based sequencing as well as Sanger sequencing. NGS sequencing can be performed using either Illumina MiSeq or NextSeq500 as per the project requirement.

We are equipped with capabilities for both NGS based sequencing as well as Sanger sequencing. NGS sequencing can be performed using either Illumina MiSeq or NextSeq500 as per the project requirement.

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Microbiology

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Protein Quantification

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Immunology Animal Models

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Biochemistry & Molecular Biology

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Immunoassays

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RNA Services

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Clinical Research

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Editorial and Writing Services

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Project Management

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Clinical Trials, Consulting, and Management

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Computational Modeling

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Imaging & Spectroscopy

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Epidemiology, Healthcare, and Post-Authorization Studies

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Biostatistics & Bioinformatics

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In vivo PK/PD Studies

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Virology Services

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Therapeutic Monoclonal Antibody (mAb) Development

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Animal Models of Disease

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Next Generation Sequencing (NGS)

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Protein Production

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Cytometry

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Cells and Tissues

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In vivo Toxicity Testing

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Product Quality Control

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Chromatin Immunoprecipitation (ChIP) Assays

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Nucleic Acid Services

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Hepatic Animal Models

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Lead Identification and Validation

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Targeted Gene Sequencing

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DNA Services

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Biomolecular Interaction Analysis

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Bioanalytical Assays

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Drug Discovery

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Business Development, Marketing & Operations

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Formulation Services

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DNA Library Services

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Pharmacology & Toxicology

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Spectroscopy

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Biology

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Protein Expression Visualization

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Materials Science

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Bacterial Culture

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Bone/Cartilage Animal Models

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Cell and Tissue Culture

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Protein-DNA Interaction Analysis

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Pain/Neuropathy Animal Models

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Antibody Services

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Animal Models and Studies

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Yeast Culture

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Viral Assays

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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
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DNA Synthesis and Probe Development

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Product Development, Testing, and Packaging

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Clinical Data Collection, Analysis and Management

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Marketing, Communication & Graphic Design Services

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Drug Discovery & Development

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Material Testing Services

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Chemistry and Materials

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Drug Development

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Pharmacology

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Pharmacology Services

Pharmacology Services

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Gastroenterology Animal Models

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Gastroenterology Animal Models Services

Gastroenterology Animal Models Services

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Regulatory Affairs Services

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Regulatory Affairs Services

Regulatory Affairs Services

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Compound Libraries

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Compound Libraries Services

Compound Libraries Services

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In vivo ADME/DMPK Studies

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In vivo ADME/DMPK Studies Services

In vivo ADME/DMPK Studies Services

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Yeast Services

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Yeast Services

Yeast Services

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Mammalian Cell Culture

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Mammalian Cell Culture Services

Mammalian Cell Culture Services

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Business Operations and Logistics Support

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Business Operations and Logistics Support Services

Business Operations and Logistics Support Services

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Product Testing Services

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Product Testing Services

Product Testing Services

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Business Development Services

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Business Development Services

Business Development Services

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Data Services

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Data Services

Data Services

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Data Analysis

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Data Analysis Services

Data Analysis Services

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Statistical Analysis

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Statistical Analysis Services

Statistical Analysis Services

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Oligonucleotides

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Oligonucleotides Services

Oligonucleotides Services

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In vitro Toxicity Testing

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In vitro Toxicity Testing Services

In vitro Toxicity Testing Services

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Chemicals, Ingredients, and Raw Materials

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Chemicals, Ingredients, and Raw Materials Services

Chemicals, Ingredients, and Raw Materials Services

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Regulatory Document Preparation and Submission

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Regulatory Document Preparation and Submission Services

Regulatory Document Preparation and Submission Services

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