TCGLifeSciences, Pvt. Limited
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Kolkata, West Bengal, IN
TCG Lifesciences Pvt Limited (formerly “Chembiotek Research International”) is a leading contract research & manufacturing company in the area of drug discovery and development. We started our operations in the year 2001 in India, currently we have our presence in United States, Europe, Japan, and China. We have a strong talent pool of 1000+ qualified and trained scientists, drawn from the best national and international institutes and industry. Our research infrastructure includes world class chemistry and biology laboratories, animal facility, electrophysiology laboratory, BSL 2 and 3 laboratory, and cGMP facilities at our R&D centers in Kolkata and Hyderabad, India and in the US.
Our chemistry services includes:
TCGLS-Medicinal chemistry Synthesis
We have experience in synthesizing compounds designed by medicinal chemists at our clients' site. We are focused on productivity and cycle time management with real time problem solving in synthesis.
Our Medicinal Chemistry Synthesis Capabilities
• End-of-day communication for all projects for quick problem solving and leveraging experience from both the sides.
• Parallel problem solving and quick purifications in all cases.
• Combiflash and Biotage Quad 3 purification tools along with a number of mass triggered preparative HPLCs.
• Smooth and hassle free procurement and outbound logistics.
• Flexible procurement and outbound logistics teams working in conjunction with the scientists.
• State-of-the art infrastructure and scientific databases like Sci-Finder and Reaxys.
• Global compound dispatch in vials, assay ready plates (DMSO) under dry ice.
TCGLS-Library synthesis
We have a long experience in synthesis of a variety of libraries ranging between focused libraries 10-30 members to large 2000 member libraries. The dedicated library synthesis team and an allied infrastructure with unidirectional flow of job from synthesis to purification to evaporation to dilution and to final QC make the process error free.
Our capabilities include synthesizing libraries in both solution and solid phase, synthesis of scaffolds/building blocks including complex structures involving multi-step synthesis in milligram to kilogram scale with coplete characterization, lead generation, lead optimization and SAR libraries generated in 5-50 mg scale with >90% purity and LCMS/UV/ELSD data for each library in customer preferred format including vials/shallow/deep/well MT plate.
Type of Chemistries Handled
Spirocyclization using beta-diketones, Suzuki coupling using variety of reagents, Nuceophillic and SNAr type aminations, amidation and esterifcation, acylation, alkylation, urea, carbamate, pyrazole, pyridone, spiroisoxazoline, oxadiazole formation, reductive amination, ether formation for large libraries, peptide libraries and solid phase amindation.
Reaction Parameter Variability
Solution phase parallel synthesis at operating temperature range of -20oC to 150oC and in inert atmosphere (when needed).
24 wellplate to 86 wellplate formats on flat bed and orbital rotary type shakers. Custom designed teflon filtration.
Purification and Characterization
Laboratory scale purification through normal/reverse phase Biotage Quad 3 systems, Combiflash systems, ABI Q trap/API 2000/Water’s analytical LCMS, Water’s and Agilent auto purification systems (DAD/Mass detectors), and analytical HPLC/UPLC systems (UV-DAD/ELS) detectors.
24 wellplate to 86 wellplate formats on flat bed and orbital rotary type shakers. Custom designed teflon filtration.
Identification of the pure fractions by FIA-MS analysis, purity of fractions established using UPLC and the pure compound further analyzed by LCMS.
TCGLS-Custom Synthesis
We have a successful track record in custom synthesis of scaffolds, building blocks, special reagents, ligands for our clients. Typical scale varies from mg to kilos. Synthesizing diverse classes of compounds including optically active ones.
Special Tools
Photo Reaction
• Ozonolysis
• Carbonylation
• Resin Based Purification
Our Custom Synthesis Capabilities
• Chiral Separation in gm scale using SFC.
• Timely delivery in predefined quality.
• Online access to project information through secured server.
• Final product/intermediates well characterized using our state-of-the-science analytical facility (NMR (350 MHz), HPLC, or LC- MS).
• Economical, environmentally benign and readily available starting materials, reagents and catalysts.
• Reports in the preferred format by the client for each compound, including protocols and data sets
TCGLS-PRD & CGMP KILO SCALE SYNTHESIS
We have a well-established kilo laboratory for the synthesis of compounds in multi grams to kilograms level. During kilo synthesis we always look for the most cost-effective route.
• Develop and optimize safe, eco-friendly and cost effective processes.
• Manufacturing of all clinical trials material under cGMP conditions.
• Support all IND enabling activities as per the international guidelines.
• Assist in reducing IND and NDA filing timelines and escalating the launch of the drug in the market.
Key Features
• Access to international quality analytical labs and facilities at the same location.
• Equipped with 20L to 200L capacity reactors to handle a wide range of reactions under-80 to +200 degree C temperature range.
• Thorough understanding of the chemistry involved for seamless technology transfer from R&D laboratory to kilo scale synthesis.
• Hazop studies prior to carrying out any unknown reaction and other HSE measures.
• Project management expertise enabling troubleshooting and problem solving on real time basis.
• Efficiency, time optimization, innovative analytical approach with highest QC standards.
• Independent and separate QA function to ensure rigid adherence to International guidelines and laid down SOPs.
• Experienced production and QA professionals.
TCGLS-Analytical chemistry
Our analytical team having deep domain experience is well equipped with international standard infrastructure to handle competing analytical projects.
Spectroscopic Capabilities
Structure elucidation of small molecules by Spectroscopic techniques and fluorine and silicon NMR capability. (Using 1D, 2D NMR experiments and MS/MS experiments).
Chromatographic Capabilities
Purity estimation of NCE's by Reverse and Normal phase Chromatography, Determination of enantiomeric excess using variety of chiral column.
Purification Capabilities
High Throughput Purification and isolation of compounds (chiral and non chiral) in mg to g scale, for Parallel Medicinal chemistry libraries and singleton compounds.
GLP Capabilities
GLP analytical lab to conduct Method development and validation as per ICH and OECD guidelines and to support Kilo-lab activity for final release of GMP material. Capable of doing short term and long term stability studies of APIs and Intermediates.
Impurity Profiling Capabilities
Isolation and characterization of unknown impurities from APIs and Formulations utilizing the strong skills in preparative isolation and structure elucidation.
TCGLS-LARGE SCALE MANUFACTURING SERVICES
Clininvent Research Pvt. Ltd, a wholly owned subsidiary of TCG Lifesciences is a US FDA approved API manufacturing facility, located in Hyderabad, India. In addition to Active Pharmaceutical Ingredients (APIs) and intermediates, Clininvent provides “Contract Research and Manufacturing” (CRAM) services of new chemical entities (NCEs) for clinical trials.
The cGMP manufacturing facility is in a 7.5 acres site and equipped with multiple reactors with ~160,000 L manufacturing capacity.
SALIENT FEATURES
· US FDA approved facility
· Pilot plant facility for carrying out optimization and
delivery of initial quantities
· High pressure hydrogenation and other pressure
reaction capabilities
· High temperature reaction at > 200 0C and high
vacuum distillation capabilities
· Clean room environment for handling APIs and NCEs
· QC release as per ICH guidelines
TCGLS-INTEGRATED CHEMICAL DEVELOPMENT SERVICES:
· New route scouting and technology development
· Process and analytical method development, validation and transfer
· Identification of critical process parameters
· Development of control strategies
· API and impurity reference standard preparation and characterization
· Provide appropriate protocols and reports for different steps of analytical and manufacturing steps
· Development and Manufacturing of Regulatory Starting Materials (RSMs)
TCGLS-US CHEMICAL DEVELOPMENT SERVICES
The vision of TCGLS-US to become the world class innovative CMC organization and integrated part of Biotech and Pharma Industry. Our locations are in Richmond, VA & Princeton, NJ.
Spearheaded by the leaderships of Dr. Chris Senanayake, and Dr. Joseph Armstrong the mission of TCGLS- US is to provide CMC packages and APIs for pre-clinical, clinical and commercial needs with an emphasis on speed, green chemistry, catalysis, and economics. Accept the challenge and responsibility of delivering CMC with the highest quality standards. World leading innovative science, state-of-the-art technologies, and close US-India-China collaboration enable TCGLS-US to develop CMC processes rapidly and in an accelerated manner.
Field Potential Recording in Hippocampal Slices:
Understanding learning, memory, stress, depression, anxiety, addition and fear
LTP, LTD, Dose Response
Effects of compounds on central synaptic function
Mechanism of Action of NCEs
Effect of NCEs on Learning and Memory
Conventional Patch Clamp:
Whole cell DRC
Multiple patch configurations
Single channel recording, single channel kinetics
Recording from specialized and primary cell lines
hERG assay
Also available: patch clamping of hippocampal slices
Automated Patch Clamp:
High throughput assay of ion channels.
Offsite facility is available on arrangement with academic partners.
Phospholipidosis – CHO-K1/HepG2 cells, NBD-PE uptake, Fluro/colorimetry
Hemolysis – Human/Rat/Mice Blood, hemoglobin in plasma by colorimetry
Cell viability/proliferation assay – MTT, Cell Titre(ATP) Glo, LDH release
AMES Test
Plate Incorporation
AMES-MPF (Xenometric)
Micronucleus (IVMN)
In Vitro:
CHO-K1
Human peripheral blood
hERG
Radio-Ligand Binding
Fluorescence Polarization
Manual Patch Clamp
NaV1.5
TCG Lifesciences In Vivo service provides validated platforms for in-depth studies in the therapeutic areas of Pain, Inflammation and CNS with special focus on Neuropathic pain. Our talented research team led by Ph.D. scientists in Pharmacology and Veterinary Sciences provide complete support from study designing to final data analysis and reporting. The TCGLS biology team offers the flexibility of using our platforms or developing customized models efficiently to enable your preclinical discovery program. Our team of In Vivo scientists work in concert with our In Vitro and Bioanalytical teams to support more complex study designs like PK/PD correlation including biomarker analysis and maximize the value of obtained research data.
The animal house of TCG Lifesciences is equipped with a state of art holding facility as well as in house breeding capabilities for reliable supply of rodent strains commonly required to support discovery research. The facility strictly adheres to the ethical guidelines of the Government of India and is under supervision of a fully compliant Institutional Animal Ethics Committee (IAEC). Our facility is licensed by Government of India to import special rodent strains as may be required by study protocols.
We routinely do custom synthesis of scaffolds, building blocks, special reagents, ligands for our clients. Typical scale varies from mg to kilos. We have experience in synthesizing diverse classes of compounds including optically active ones.
Special tools include
Timely delivery in predefined quality.
Online access to project information through secured server.
Final product/intermediates well characterized using our state-of-the-science analytical facility (NMR (350 MHz), HPLC, or LC-MS).
Flexible synthetic scale from milligrams to kilogram.
We put our major focus on cheap, environmentally benign and readily available starting materials, reagents and catalysts.
We supply written reports in the preferred format needed by the client for each compounds which includes protocol and data set.
We have a well-established kilo laboratory for the synthesis of compounds in multi grams to kilograms level. During kilo synthesis we always look for the cost effectiveness.
Our expertise lies in synthesizing chemical entities of any structural complexity, including new ones.
Our team of experienced medicinal chemists has a proven track record in running integrated discovery programs starting from ’hit generation’ to ‘identifying preclinical candidates’. The team works in close collaboration with In Vitro pharmacologists, DMPK and In Vivo pharmacologists, and computational chemists. The programs have three main stages:
Designing of compounds for Novel targets or Fast-followers program are done following different approaches:
In case of fast-followers programs our medicinal chemists have been instrumental by proposing novel new molecular entities (NME) and also tool compounds to take the program forward in stringent time frame.
For synthesis, in house parallel synthesis expertise are used majorly to build focused libraries to answer key Structure Activity Relationship (SAR) and Structure Property Relationship (SPR) questions.
Syntheses in singleton mode are also run in parallel.
We have successfully completed projects from ‘early hit to preclinical development stage’ by developing a number of lead candidates with required biological properties for our clients within the specified time frame and maintaining highest standards of data quality.
Develop innovative assays and screening methods to evaluate the effects of chemical compounds on cellular, molecular and biochemical processes. The screens, further help to unravel cell functions/biological process and could become potential therapeutic candidates in drug development pipeline.
Expertise includes:
Toxicokinetic (TK) Modeling:
Acetic Acid induced Writhing
Pain/Neuropathy Animal Models Services
Inflammation Animal Models Services
Immunology Animal Models Services
Biology Services
Pharmacology Services
Pharmacology & Toxicology Services
Mammalian Cell Culture Services
Cell and Tissue Culture Services
Cells and Tissues Services
Manufacturing Services
Synthetic Chemistry Services
Chemistry and Materials Services
ADME/DMPK Studies Services
In vivo Toxicity Testing Services
Cell Viability & Proliferation Assays Services
Cell-Based Assays Services
Cytotoxicity Assays Services
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