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WuXi Advanced Therapies

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Philadelphia, Pennsylvania, US

About WuXi Advanced Therapies

Divison of: WuXi AppTec

Accelerating the Progress and Time to Market of Bio-Based Drugs through Integrated Manufacturing and Laboratory Testing Services

By leveraging platforms and integrated testing, the Advanced Therapies business unit of WuXi AppTec is a streamlined Contract Development and Manufacturing Organization (CDMO),... Show more »

Accelerating the Progress and Time to Market of Bio-Based Drugs through Integrated Manufacturing and Laboratory Testing Services

By leveraging platforms and integrated testing, the Advanced Therapies business unit of WuXi AppTec is a streamlined Contract Development and Manufacturing Organization (CDMO), pioneering the expedited development and commercialization of cell, gene, protein and viral-based therapies. This approach enables new biopharmaceuticals to be developed, manufactured and released faster and with greater predictability, thereby reducing the complexities of high-touch, multi-vendor production models.

Our solutions help clients overcome challenges to commercialization, including process development, manufacturing capacity, analytical development, and raw materials management. Multiple, scale-able, enabling platforms integrate manufacturing, process development and testing capabilities to provide greater predictability and speed to clinic. Well positioned for growth, our investments in personnel and manufacturing continue to expand clinical and commercial capacities. Since 2004, WuXi AppTec has supported Advanced Therapy programs with an extensive infrastructure of state-of-the-art, GMP-compliant facilities, providing centers of excellence for manufacturing and testing.

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Our Services (63)


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IND-Enabling Studies

Price on request
Request a quote for more information about this service.

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Adventitious Agent Testing

Price on request

Unprocessed Bulk is the Best Place in the Process to Screen for Adventitious Agents. To accurately recognize them, WuXi Advanced Therapies offers cutting-edge, next-gen sequencing services for virus detection in protein, viral, gene and cell-based therapeutics. This sensitive, emerging technology capably IDs known or novel... Show more »

Unprocessed Bulk is the Best Place in the Process to Screen for Adventitious Agents. To accurately recognize them, WuXi Advanced Therapies offers cutting-edge, next-gen sequencing services for virus detection in protein, viral, gene and cell-based therapeutics. This sensitive, emerging technology capably IDs known or novel adventitious agents. NGS also provides a better understanding of the consistency and integrity of raw materials and therapeutic products. Based on discussions with the client, we will determine the most effective strategy for detecting adventitious agents, with an eye toward security, access, ideal platforms and optimized data management.

With Decades of history and expert support teams, our programs are designed to meet your needs: Faster, more cost effective and less complicated.
• Unique capabilities to assess, conduct, analyze and advise on adventitious agent control strategies
• Ability to detect contaminants from a wide-variety of product types and biological sample matrices
• Ideal methods for testing raw materials, in-process samples, cell or viral bank seed material
• Experience from analyzing thousands of samples using cell-based, in-vivo & qPCR methods
• Wide range of biosafety assays to provide appropriate follow-up studies

CONTACT our experts to help you detect and ID contaminants in raw materials, characterize a cell or virus bank, or assist you with other adventitious agent topics

Service Offerings
• Bulk product testing
• Contamination control
• Virus screens
• Mycoplasma testing
• Microbial limits / bioburden
• Microbiology testing & assays
• Cleaning, disinfection, sanitization & anti-microbial efficacy
• Sterility, bioburden and endotoxin testing

Technology Platform
• AgentSCREENSM - In-depth analysis for the presence of adventitious virus
• AgentIDSM - Targeted detection of adventitious agents
• Membrane filtration, pour plate, inoculated product sterility and repetitive recovery for bioburden
• Chromogenic, turbidimetric, gel clot and method suitability (I/E) for endotoxin
• Culture / PCR for mycoplasma testing
• Quantitative electron microscopy
• Product titer assays
• Analytical (identity, purity, concentration)
• Potency / Cell-based assays
• ddPCR or qPCR for genome copy
• Replication-competent lentivirus assay

Advanced sequencing platforms demonstrate our dedication to service excellence. Expert teams are trained on a range of instruments to meet exacting needs, depending on the sample submitted and designated requirements. Our established sequence database encompasses all known virus families and species. Bioinformatics and virology experts partner to provide thorough, detailed analysis of any identified virus sequences.

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Animal Models and Studies

Price on request

• Animal models and routes of administration (ROA)
• State-of-the-art animal study rooms and surgical suites
• Animal cell lines and animal viruses
• Fully accredited AAALAC facilities for GLP animal assays
• In vivo transgene expression | In vivo vector persistence
• In-vivo proof-of-concept studies

• Animal models and routes of administration (ROA)
• State-of-the-art animal study rooms and surgical suites
• Animal cell lines and animal viruses
• Fully accredited AAALAC facilities for GLP animal assays
• In vivo transgene expression | In vivo vector persistence
• In-vivo proof-of-concept studies

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Antibody-Drug Conjugate (ADC) Development

Antibody Drug Conjugate Development
Price on request

WuXi Advanced Therapies provides extensive manufacturing and testing services for protein-based biopharmaceuticals, including antibody-drug conjugates (ADCs)

WuXi Advanced Therapies provides extensive manufacturing and testing services for protein-based biopharmaceuticals, including antibody-drug conjugates (ADCs)

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Bioburden Testing

Price on request

The technology platform for bioburden includes membrane filtration, pour plate, inoculated product sterility and repetitive recovery

Related Service Offerings
• Contamination control
• Virus screens
• Mycoplasma testing
• Microbial limits
• Microbiology testing & assays
• Cleaning, disinfection, sanitization & anti-microbial efficacy
• Sterility and endotoxin testing

The technology platform for bioburden includes membrane filtration, pour plate, inoculated product sterility and repetitive recovery

Related Service Offerings
• Contamination control
• Virus screens
• Mycoplasma testing
• Microbial limits
• Microbiology testing & assays
• Cleaning, disinfection, sanitization & anti-microbial efficacy
• Sterility and endotoxin testing

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Biopharmaceutical Manufacturing

Price on request

Contract development and manufacturing (CDMO) services for cell, gene, protein and viral-based therapeutics, including CAR-T, immunotherapy, autologous and allogeneic. Our combination of flexible service, options, advanced capabilities, unmatched expertise and state-of-the-art facilities provides clients a distinct advantage: a... Show more »

Contract development and manufacturing (CDMO) services for cell, gene, protein and viral-based therapeutics, including CAR-T, immunotherapy, autologous and allogeneic. Our combination of flexible service, options, advanced capabilities, unmatched expertise and state-of-the-art facilities provides clients a distinct advantage: a unique single-source for biotherapeutics services — from procurement, process development, cell expansion, and fill/finish to comprehensive product testing and release. We provide an integrated set of services and the capacity needed to get therapies to market with the shortest timeline possible.

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Biopharmaceutical Process Development

Price on request
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Bioprocess Development and Scale-Up

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CAR-T Cell Therapy Development

Price on request

Contract development and manufacturing (CDMO) services for Chimeric Antigen Receptor T (CAR-T) Cells. Our combination of flexible service, options, advanced capabilities, unmatched expertise and state-of-the-art facilities provides cell therapy clients a distinct advantage: a unique single-source for biotherapeutics services —... Show more »

Contract development and manufacturing (CDMO) services for Chimeric Antigen Receptor T (CAR-T) Cells. Our combination of flexible service, options, advanced capabilities, unmatched expertise and state-of-the-art facilities provides cell therapy clients a distinct advantage: a unique single-source for biotherapeutics services — from procurement, process development, cell expansion, and fill/finish to comprehensive product testing and release. We provide an integrated set of services and the capacity needed to get therapies to market with the shortest timeline possible.

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Cell and Tissue Culture

Price on request

Cell and Tissue Culture Services

Cell and Tissue Culture Services

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Cell Line Authentication

Price on request

Quality, Experience, Expertise and Leadership in Cell Line Characterization.

Characterization of cell lines used in biopharmaceutical production requires expertise across a wide range of biological disciplines. Thorough knowledge, gained through hundreds of completed studies, helps us develop testing regimens that ensure... Show more »

Quality, Experience, Expertise and Leadership in Cell Line Characterization.

Characterization of cell lines used in biopharmaceutical production requires expertise across a wide range of biological disciplines. Thorough knowledge, gained through hundreds of completed studies, helps us develop testing regimens that ensure acceptance by worldwide regulatory agencies. To successfully conduct these critical testing programs, we leverage industry-leading know-how and facilities, including technical, regulatory, laboratories, assays and quality oversight. Our team will consult with you to determine a cost-effective testing regimen that stands-up to regulatory scrutiny.
No false positives have been detected when assessing cell line purity in our hands. Robust, specific Next Gen Sequencing methods pair with industry-leading turnaround times for an attractive combination. Which tests to conduct, at which stage – and the quality oversight required – is where our extensive experience can make the critical difference.

The numbers speak for themselves!
• > 30,000 microbiology samples processed/per month
• Over 50 cell lines of human and animal origin and over 60 human and animal viruses
• Over 40 viral PCR probes and over 100 PCR assays developed and implemented to assess potential virus contamination
• Customers have submitted over 250 cell lines for NGS-driven cell line ID, with all meeting assay validity and confirmed species identity

CONTACT US to learn how our dedicated, highly-trained, professional staff take raise the bar for your cell line characterization program

Program Overview

Our services complement worldwide regulatory guidance documents, which outline tests typically required to characterize cell lines for cGMP cell bank production. A variety of in-vitro, cell-based and in-vivo tests are available.

• Cell categories
o Master cell bank
o Manufacturer’s working cell bank
o End of production cells
o Cells at the limit of in vitro cell age

• Authenticity & characteristics
o Identity
o Growth / Morphology
o Genetic stability
o Tumorigenicity

• Adventitious agents
o Sterility
o Mycoplasma
o General virus screens
o Species-specific virus tests
o Retrovirus test
o Adventitious agents from raw material

Technology Platform
• Targeted Next Generation Sequencing (NGS) identifies species of origin and detects any interspecies contamination
• STR analysis for identity of human cell lines
• XC plaque, PG4 S+L- and co-cultivation assays for retrovirus detection
• Isoenzyme analysis, flow cytometry &/or ELISA assays to ID cell lines and markers
• qPCR for copy number determination, and the ID and quantification of species-specific virus
• TD-PCR for detection of mycoplasma
• Southern & Northern Blotting
• DNA & RT-PCR cDNA sequencing
• BacT® Alert available for cell line characterization

Compliance / Regulatory / Quality
Regulatory agencies expect characterization of cell banks used for manufacture of biological products, to confirm species identity and screen for contamination by other species
• IFA endpoints
• 9 CFR protocols to detect adventitious virus
• GMP report for written assessment
• US and EU requirements followed for detection of adventitious virus
• Harmonized USP/EP/JP protocols for microbial assays
• CFR or Points-to-Consider protocols and guidelines are available
• Expert advice on worldwide regulatory requirements from highly trained and skilled personnel
• Well-documented cell line growth characteristics as required for CLC programs

Genetic Stability
Our experienced staff and state-of-the-art labs employ the latest techniques and instrumentation to efficiently assess the genetic stability of your cell line. Understanding the genetic stability of your production cell line, from master cell bank to end of productions cells, is critical component for regulatory filing. Genetic stability analysis encompasses a wide variety of molecular biology techniques.

Facilities
• Dedicated virology, molecular biology, cell biology and analytical labs
• Fully accredited AAALAC facilities for GLP animal assays
• Individual sterility and mycoplasma laboratories

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Cell Line Characterization

Price on request

Quality, Experience, Expertise and Leadership in Cell Line Characterization.

Characterization of cell lines used in biopharmaceutical production requires expertise across a wide range of biological disciplines. Thorough knowledge, gained through hundreds of completed studies, helps us develop testing regimens that ensure... Show more »

Quality, Experience, Expertise and Leadership in Cell Line Characterization.

Characterization of cell lines used in biopharmaceutical production requires expertise across a wide range of biological disciplines. Thorough knowledge, gained through hundreds of completed studies, helps us develop testing regimens that ensure acceptance by worldwide regulatory agencies. To successfully conduct these critical testing programs, we leverage industry-leading know-how and facilities, including technical, regulatory, laboratories, assays and quality oversight. Our team will consult with you to determine a cost-effective testing regimen that stands-up to regulatory scrutiny.

No false positives have been detected when assessing cell line purity in our hands. Robust, specific Next Gen Sequencing methods pair with industry-leading turnaround times for an attractive combination. Which tests to conduct, at which stage – and the quality oversight required – is where our extensive experience can make the critical difference.

The numbers speak for themselves!
• > 30,000 microbiology samples processed/per month
• Over 50 cell lines of human and animal origin and over 60 human and animal viruses
• Over 40 viral PCR probes and over 100 PCR assays developed and implemented to assess potential virus contamination
• Customers have submitted over 250 cell lines for NGS-driven cell line ID, with all meeting assay validity and confirmed species identity

CONTACT US to learn how our dedicated, highly-trained, professional staff take raise the bar for your cell line characterization program

Program Overview

Our services complement worldwide regulatory guidance documents, which outline tests typically required to characterize cell lines for cGMP cell bank production. A variety of in-vitro, cell-based and in-vivo tests are available.

• Cell categories
o Master cell bank
o Manufacturer’s working cell bank
o End of production cells
o Cells at the limit of in vitro cell age

• Authenticity & characteristics
o Identity
o Growth / Morphology
o Genetic stability
o Tumorigenicity

• Adventitious agents
o Sterility
o Mycoplasma
o General virus screens
o Species-specific virus tests
o Retrovirus test
o Adventitious agents from raw material

Technology Platform
• Targeted Next Generation Sequencing (NGS) identifies species of origin and detects any interspecies contamination
• STR analysis for identity of human cell lines
• XC plaque, PG4 S+L- and co-cultivation assays for retrovirus detection
• Isoenzyme analysis, flow cytometry &/or ELISA assays to ID cell lines and markers
• qPCR for copy number determination, and the ID and quantification of species-specific virus
• TD-PCR for detection of mycoplasma
• Southern & Northern Blotting
• DNA & RT-PCR cDNA sequencing
• BacT® Alert available for cell line characterization

Compliance / Regulatory / Quality
Regulatory agencies expect characterization of cell banks used for manufacture of biological products, to confirm species identity and screen for contamination by other species
• IFA endpoints
• 9 CFR protocols to detect adventitious virus
• GMP report for written assessment
• US and EU requirements followed for detection of adventitious virus
• Harmonized USP/EP/JP protocols for microbial assays
• CFR or Points-to-Consider protocols and guidelines are available
• Expert advice on worldwide regulatory requirements from highly trained and skilled personnel
• Well-documented cell line growth characteristics as required for CLC programs

Genetic Stability
Our experienced staff and state-of-the-art labs employ the latest techniques and instrumentation to efficiently assess the genetic stability of your cell line. Understanding the genetic stability of your production cell line, from master cell bank to end of productions cells, is critical component for regulatory filing. Genetic stability analysis encompasses a wide variety of molecular biology techniques.

Facilities
• Dedicated virology, molecular biology, cell biology and analytical labs
• Fully accredited AAALAC facilities for GLP animal assays
• Individual sterility and mycoplasma laboratories

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Cell Lines

Price on request

Cell Lines Services

Cell Lines Services

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Leak Testing

Price on request

Product Packaging Characterization

When it comes to Characterizing Containers & Closures, We’ve got your Success in the Bag
Our overall product stability testing and validation program includes integrity and container closures for package systems, as well as transportation and storage evaluations. The Advanced Therapies unit... Show more »

Product Packaging Characterization

When it comes to Characterizing Containers & Closures, We’ve got your Success in the Bag
Our overall product stability testing and validation program includes integrity and container closures for package systems, as well as transportation and storage evaluations. The Advanced Therapies unit employs a comprehensive menu of sterility assurance services. Bags, tubing, filters... no matter the product... our expert scientists work with customers to develop successful protocols for single-use systems. We hold experience with BPOG and BPSA protocols, with modified versions of both.

Our team of chemists and toxicologists design studies to meet your needs – from traditional packaging to complex delivery systems that place your device in the combination products spectrum.
• Required integrity testing after each stability and transportation test
• Unmatched capacity for a wide range of temperatures and humidity
• Compliance with FDA guidance for safety evaluation: A must for primary packaging components that are - or may be in direct contact with - the dosage form

CONTACT our experts to design testing programs that meet regulatory requirements for containers, closures, packaging, devices, biologics and combination products.

Stability, performance and container closure: Integrity testing services, capabilities and validations
• Sterile barrier systems, seal strength, integrity and packaging compliance
• Performance under physical and environmental stress
• Aging, expiration date determination
• Compatibility with the product and sterilization process
• Performance, transportation
• Biocompatibility, extractables & leachables
• Material chemical characterization

Technology Platform
• Accelerated and real-time shelf life studies
• Liquid dye immersion with vacuum
• Simulated distribution
• Low pressure / high altitude (LPHA) test
• Drop, compression, concentrated impact and vibration testing

Compliance / Regulatory / Quality
ISO 11607 Intl. Organization for Standardization: Packaging for terminally sterilized medical devices
ANSI American National Standards Institute
AAMI Association for the Advancement of Medical Instrumentation
ASTM American Society for Testing and Materials
ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems
CBER Center for Biologics Evaluation and Research
CDER Center for Drug Evaluation and Research
ISTA International Safe Transit Association
ISTA Thermal Transport Package Testing (Cold-Chain)
USP United States Pharmacopeia
ICH Intl. Conf. on Harmonization: Tech. Requirements for Registration of Pharmaceuticals for Human Use
PDA Parenteral Drug Association Technical Report 27 (TR 27): Pharmaceutical Package Integrity

WuXi Advanced Therapies offers a comprehensive range of analytical testing services to characterize complex biologics, vaccines and advanced therapies. Many of these assays can then be further developed and validated to measure product quality and consistency in lot release and stability testing programs. We provide services for mAbs, rProteins, Peptides, Viral Vaccines, VLP Vaccines, Gene Therapy Vectors (Virus or Plasmid-based), Cellular Therapeutics or Whole Cell Vaccines, as well as Biologic + Medical Device.

Why Us?
• Programs for a wide variety of biologics
• Comprehensive stability study programs
• Development and validation of stability-indicating assays
• Understanding of, and adherence to ICH and regulatory guidelines
• Reference standard characterization

CONTACT US to design and implement comprehensive product stability testing and storage programs to meet regulatory and client requirements

Program Overview
• General characterization
• Purity
• Impurity
• Identity
• Potency
• Safety

Technology Platform
A variety of analytical methods are available including compendial and client specific/custom assays
• Concentration, visual appearance, particulates, pH, osmolality
• SDS-PAGE, SEC-HPLC, IEX-HPLC, CE-SDS, cIEF
• ELISAs, qPCR, Western blotting
• Bioassays, ELISA, IEF-PAGE, cIEF, peptide mapping, sequencing via LC/MS/MS
• Endotoxin, bioburden, sterility/CCIT, virology, mycoplasma

Compliance / Regulatory / Quality
• Stability programs conducted under GMP guidelines
• Individual assays under GMP conditions with quality oversight
• Methods validation according to ICH guidelines
• Q1A(R2) Stability Testing of New Drug Substances and Products
• Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
• Q1B Stability Testing: Photostability Testing of New Drug Substances and Products
• USP Section 1049 Quality of Biotechnological Products: Stability Testing of Biotechnological /

Biological Products
• 21CFR Part 211.166 Federal Code of Regulations, Title 21 Volume 4, Stability Testing

Our history of success translates to confidence for your future analytical development. For virus-based products, vaccines or gene therapy vectors, our decades-long history in virology testing supports stability studies for these type of products. Methods include virus particle or infectious virus titer, IFA and dynamic light scattering for aggregates. DNA or qPCR sequencing can be used for identity testing utilizing our molecular biology expertise.

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Customized Systems for Manufacturing of Autologous Cell Therapies

Price on request

Contract development and manufacturing (CDMO) services for Autologous Cell Therapies. Our combination of flexible service, options, advanced capabilities, unmatched expertise and state-of-the-art facilities provides cell therapy clients a distinct advantage: a unique single-source for biotherapeutics services — from procurement,... Show more »

Contract development and manufacturing (CDMO) services for Autologous Cell Therapies. Our combination of flexible service, options, advanced capabilities, unmatched expertise and state-of-the-art facilities provides cell therapy clients a distinct advantage: a unique single-source for biotherapeutics services — from procurement, process development, cell expansion, and fill/finish to comprehensive product testing and release. We provide an integrated set of services and the capacity needed to get therapies to market with the shortest timeline possible.

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DNA Vaccine and Gene Therapy Vectors

Price on request

Trusted Leadership in Contract MFG and Testing Programs for Viral Based Therapies

The Advanced Therapies vaccine testing program comprises a full spectrum of services to speed viral-based therapeutics from discover to commercialization. We offer testing programs for viral, VLP, whole cell, protein, peptide and DNA-based... Show more »

Trusted Leadership in Contract MFG and Testing Programs for Viral Based Therapies

The Advanced Therapies vaccine testing program comprises a full spectrum of services to speed viral-based therapeutics from discover to commercialization. We offer testing programs for viral, VLP, whole cell, protein, peptide and DNA-based vaccines. With many years of experience in providing fully integrated vaccine biosafety testing programs, our team has backed numerous, effective projects. Advanced Therapies can develop or perform technology transfer from the Sponsor for biosafety and analytical methods required to release product lots. Importantly, we test for replication-competent virus that may have been produced through recombination during preparation and ex vivo patient treatment with retroviral-based gene therapies and gene-mediated cell therapies.

We Provide Confidence for your Viral Therapy Testing Needs
• Our quality systems have been audited and accepted by regulatory authorities worldwide
• Trusted leadership in viral bank characterization
• Comprehensive portfolio of testing services and assays to support AAV and Lenti-based programs
• Decades of viral vector testing experience
• We cover all required testing for each manufacturing step

CONTACT US to learn more about our full line-up of testing services for viral-based therapies.

In addition to extensive testing common to all our bio-based therapeutics, we offer detailed services and technologies specific for viral-based therapies. Safety and characterization assays for gene-mediated cell therapies cover master cell bank, working cell bank, end of production cells, vector-containing supernatant and ex vivo transduced cells.
• Viral product stability
• Viral identity, titer and genetic characterization
• Viral clearance / inactivation
• Adventitious virus detection
• Detection of viral process-related impurities
• Adeno-associated virus (AAV)
• General virus screens and Species-specific virus tests
• Replication-Competent Retrovirus (RCR) and Lentivirus (RCL) Testing

Compliance / Regulatory / Quality
• GMP testing programs
• USP testing services, assays
• Successful support of BLA and IND applications
• ICH validation
• All regulatory authority-mandated assays for worldwide biosafety analysis of viral stocks
• FDA and EMA framework for safety and characterization of viral vector-based products

An Advanced Therapies Success Story: Leadership in AAV & Lentivirus Testing
Viral vectors are effective vehicles for delivering the next generation of cell and gene therapies. Due to the complexity of viral vector systems, the development process, and the intricacies of ex vivo or in vivo patient administration, ensuring the overall safety and the full characterization of these therapeutics is paramount. From master cell bank creation through lot release, we provide clients a complete set test options to ultimately protect patients.

Facilities
• Multiple suites
• World-class laboratories
• Comprehensive equipment portfolio

WuXi Advanced Therapies offers viral vector manufacturing with the WuXi Hyper PRO(tm) Platform, a closed, adherent production system suitable for lentivirus, and adaptable to AAV vectors. The WuXi Hyper-PRO™ system features favorable predictability and time to clinic, with GMP vectors in 7-8 months. Custom product development and manufacturing capability is available, and we support commercial manufacturing.

We've been manufacturing GMP grade rAAV vectors for early-phase clinical trials since Q4 2015, including experience with triple-transfection and viral-mediated production systems.

WuXi Advanced Therapies recognized a need for lentiviral vectors, and invested in process. In parallel, we worked to reduce time delays, program hurdles and risks with batch records, SOPs, and materials. Why Lentivirus Vectors?

  • Accommodate large transgenes (>8kb)
  • Efficient gene transfer
  • Infect dividing and non-dividing cells
  • Stably integrate into target cell genome for long term expression
  • Multiple applications for therapy (ex-vivo/in-vivo)
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Downstream Processing

Price on request

Process & QC Analytical Validation
cGMP Manufacturing
Product Release / Stability Testing
Patient Monitoring Analyses

Process & QC Analytical Validation
cGMP Manufacturing
Product Release / Stability Testing
Patient Monitoring Analyses

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Endotoxin Testing

Price on request

• Chromogenic, turbidimetric, gel clot and method suitability (I/E) for endotoxin

• Chromogenic, turbidimetric, gel clot and method suitability (I/E) for endotoxin

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Extractable and Leachable Testing

Price on request

When developing an Extractables & Leachables (E&L) testing program for Single Use Systems (SUS), remember - Unknowns are Unacceptable!

Extractables & Leachables data – along with risk assessment – are critical components of biologics testing programs. E&L data is especially pertinent to regulatory and industry groups, which... Show more »

When developing an Extractables & Leachables (E&L) testing program for Single Use Systems (SUS), remember - Unknowns are Unacceptable!

Extractables & Leachables data – along with risk assessment – are critical components of biologics testing programs. E&L data is especially pertinent to regulatory and industry groups, which increasingly use it to support product safety and understand process quality. Regardless of protocol or product, there is one constant: Complete identification is required to understand your product and its potential risks.

Reasons to work with WuXi Advanced Therapies for process residual testing:
• Industry leader with expertise, experience and tools that set us apart to successfully support large biopharma clients with recurring projects
• Full characterization of process-related contaminants or impurities in bulk substance or final product
• Extractables & Leachables (E&L) testing for Single Use Systems (SUS)
• Proprietary database aids identification

To develop a sound study to support safety, you need to understand the risk of your components, including proximity to the final product, duration of contact, contact area, the type of plastic the product is made from and dose & route of exposure to patient. The goal of an E&L Program should be to identify ALL of the potential chemicals that could come out of product, in order proper risk assessment. To do this, you need to understand your product and process, challenge your product to maximize the extractable chemicals, and utilize multiple analytical methods to ensure the full range of chemicals are detected and identified.

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Filtration Services

Price on request
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Filtration Sterilization

Price on request
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Filtration Testing

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Gene Therapy Development

Price on request

Comprehensive, Full-service Gene Therapy Testing Programs from Start to Finish

Building the right safety testing program requires expertise and experience in a broad range of disciplines, including virology, molecular biology and cell-based techniques. To meet your challenges, WuXi Advanced Therapies hits aggressive timelines... Show more »

Comprehensive, Full-service Gene Therapy Testing Programs from Start to Finish

Building the right safety testing program requires expertise and experience in a broad range of disciplines, including virology, molecular biology and cell-based techniques. To meet your challenges, WuXi Advanced Therapies hits aggressive timelines through test plan design, custom assay development, multiple testing methods, phase-appropriate validation and integrated data packages.

Why Us?
• Dedicated project management teams
• Phase-specific regulatory test plans generate high-quality data, updated in timely communications
• Extensive experience with a wide variety of viral vectors, e.g. Lentivirus, Adenovirus, AAV, Retrovirus, Baculovirus, Vaccinia, Poxvirus & more
• Full-service testing solutions from beginning to end: Cell and virus banks, unprocessed bulk, in-process, drug substance, drug product

Program Overview
• Gene expression, infectivity & expression assays
• Genetic stability testing
• Testing and release of GMP vector lots
• Viral clearance validation for clearance of helper viruses
• Preclinical services
• Raw material testing
• Toxicology, tumorigenicity
• Purity, identity, potency
• Safety, risk assessment
• Patient monitoring testing, biodistribution
• Sterility, mycoplasma, endotoxin, bioburden

Technology Platform
• Viral vectors, Viral bank safety & characterization
• Vector content, dose, titer
• DNA and vector genome sequencing, genomic copy by qPCR
• Replication-competent virus: rcAAV, RCL, RCR, RCA
• In vitro assay for adventitious viral contaminants
• In vivo transgene expression | In vivo vector persistence
• Capsid protein identity & purity
• Empty:Full capsid (OD 260/280)
• Aggregation by dynamic light scattering
• Capsid protein purity

Compliance / Regulatory / Quality
• GLP/GMP and compendial assays
• Results are delivered via thoroughly-reviewed, interpreted data reports, accompanied by extensive regulatory support.

Comprehensive gene therapy assay programs conform to our platform strategy, and are tailored to your specific testing needs. With an integrated approach to gene testing program design, we consult with clients to understand the goals and product, including timelines and deliverables for vectors, cell lines and clinical phase. In addition to standardized, broadly applicable approaches that withstand the test of time, we can customize project plans to unique requirements.

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Genetic Stability Testing

Price on request

Genetic Stability Testing ensures the safety of therapeutic biologicals derived from recombinant DNA. It can be used for cell line ID and purity testing. WuXi Advanced Therapies offers experienced staff and a fully equipped sequencing laboratory.

Methods include:

  • Southern Blot: Evaluates stability & insertion patterns of... Show more »

Genetic Stability Testing ensures the safety of therapeutic biologicals derived from recombinant DNA. It can be used for cell line ID and purity testing. WuXi Advanced Therapies offers experienced staff and a fully equipped sequencing laboratory.

Methods include:

  • Southern Blot: Evaluates stability & insertion patterns of bio-product gene expression construct introduced into host
  • Northern Blot: Confirms transcript stability in host cell during production of a biologic
  • Gene Copy Number (CPN) Assay by qPCR: Quantitatively measures CPN of gene expression construct introduced into host cell to produce bio-product
  • DNA Sequencing: Sanger or Next Generation (NGS)
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Human Cell Line Authentication

Price on request

For cell line authentication, WuXi Advanced Therapies offers species identity and purity analysis using robust, specific, targeted Next Generation Sequencing (NGS) methods. Regulatory agencies expect characterization of cell banks used for manufacture of biological products, to confirm species identity and screen for contamination... Show more »

For cell line authentication, WuXi Advanced Therapies offers species identity and purity analysis using robust, specific, targeted Next Generation Sequencing (NGS) methods. Regulatory agencies expect characterization of cell banks used for manufacture of biological products, to confirm species identity and screen for contamination by other species. We perform STR analysis for identity of human cell lines, and developed an Identity method for non-human cell lines using targeted NGS, which sequences only regions of interest, followed by PCR to amplify the target regions.

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In vitro Immunotoxicity Testing

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In vitro Toxicity Testing

Price on request

In vitro Toxicity Testing Services

In vitro Toxicity Testing Services

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In vivo Biosafety Testing

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in vivo Toxicology

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In vivo Hepatotoxicity Testing

Price on request
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in vivo Toxicology

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In vivo Toxicity Testing

Price on request

In vivo Toxicity Testing Services

In vivo Toxicity Testing Services

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Batch Release Testing

Price on request

High-Quality, Rapid Lot Release for Biologics and Raw Materials

Regulatory guidelines for biopharmaceutical development dictate that testing be conducted to confirm safety, identity, and consistency for incoming raw materials, harvested bulk and final product. To meet expectations for all current regulatory requirements, our... Show more »

High-Quality, Rapid Lot Release for Biologics and Raw Materials

Regulatory guidelines for biopharmaceutical development dictate that testing be conducted to confirm safety, identity, and consistency for incoming raw materials, harvested bulk and final product. To meet expectations for all current regulatory requirements, our experts are available to suggest appropriate testing for different biologics. We recommend clients consult with regulatory bodies to ensure lot release programs address all product characterization and biosafety issues. Our decades of experience with multiple clinical and commercial products, and uniquely broad services menu, provide manufacturers with a single-source solution to support their QA and QC programs.

Highly trained project managers coordinate qualifications, validations, schedules, shipments, preliminary results and other project needs. We work closely with you, from samples arrival to certificate delivery.
• Timely lot release testing
• Rapid Sterility Testing: Key to expedited process sterility screening and/or release
• Testing programs audited and accepted by regulatory authorities worldwide for decades
• QA reviews raw data and reports for 100% of tests involved in GMP biologics lot release programs
• Robust operational excellence and continuous improvement program featuring LEAN techniques
• Web-based, online tool for 24/7 access to assay status
• View assay status from sample arrival to the certificate delivery

CONTACT our experts for suggestions on appropriate testing for different biologics to meet expectations for all current regulatory requirements

Program Overview
• Assay development, qualification, validation & tech transfer
• In-process, bulk & final product testing
• Test article validation
• Raw materials testing
• Product identity, potency, purity
• Adventitious agent safety

Technology Platform
• Product titer, molecular & infectious titer determinations
• Potency, analytical and infectivity-based assays
• Next-Gen sequencing, PCR Assays
• Sterility, pyrogenicity, endotoxin, microbial enumeration, mycoplasma
• In vitro / In vivo virus screens
• Quantitative EM
• Residual DNA & DNA sizing
• Host cell protein
• General safety

Compliance / Regulatory / Quality
• GMP assays for multiple stages in the biologics manufacturing process
• GMP certification from EMA and TGA for specific commercial lot release programs
• 9 CFR virus screens for animal-derived raw materials
• ISO 17025 certified facilities
• USP/EP & TD-PCR Mycoplasma Testing
• Certificates of Analysis (CoA) and Certificates of Testing (CoT)

Adeptness in Technical Transfer: The Advanced Therapies unit has years of experience in transferring client protocols or SOPs. We consult with the client on many aspects of the transfer process – including instrumentation or technology to be used, detection methods, raw materials and other assay components – to ensure comparability before moving to the next phase of assay transfer or development.

Facilities
• All U.S.-Based facilities have ISO 17025 certified
• ICH Compliant Storage Conditions
• Regular capacity analysis to determine required resources for your needs: Facilities, suites, labs, equipment, personnel

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Mammalian Cell Culture

Price on request

Mammalian Cell Culture Services

Mammalian Cell Culture Services

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Manufacturing Services

Price on request

WuXi Advanced Therapies offers clinical and commercial contract manufacturing of cell, gene, protein and viral-based therapies, including CAR-T, immunotherapy, autologous and allogeneic. Our combination of flexible service, options, advanced capabilities, unmatched expertise and state-of-the-art facilities provides clients a... Show more »

WuXi Advanced Therapies offers clinical and commercial contract manufacturing of cell, gene, protein and viral-based therapies, including CAR-T, immunotherapy, autologous and allogeneic. Our combination of flexible service, options, advanced capabilities, unmatched expertise and state-of-the-art facilities provides clients a distinct advantage: a unique single-source for biotherapeutics services — from procurement, process development, cell expansion, and fill/finish to comprehensive product testing and release. We provide an integrated set of services and the capacity needed to get therapies to market with the shortest timeline possible.

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Mycoplasma Testing

Price on request

We offer expert Mycoplasma DNA Detection by TD-PCR - Rapid (GMP), a validated, fast, sensitive protocol that's different than qPCR or ddPCR. Our published validation demonstrates a high degree of specificity for the method. No false positives were observed when challenged with several closely-related and not so closely related DNA from other species.

Cell culture method is also available.

We offer expert Mycoplasma DNA Detection by TD-PCR - Rapid (GMP), a validated, fast, sensitive protocol that's different than qPCR or ddPCR. Our published validation demonstrates a high degree of specificity for the method. No false positives were observed when challenged with several closely-related and not so closely related DNA from other species.

Cell culture method is also available.

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Package and Container Testing

Price on request

Product Packaging Characterization

When it comes to Package and Container Testing, WuXi Advanced Therapies relies on deep industry experience and expertise to ensure rigorous, well-documented studies. Our overall product stability testing and validation program includes integrity and container closures for package systems, as... Show more »

Product Packaging Characterization

When it comes to Package and Container Testing, WuXi Advanced Therapies relies on deep industry experience and expertise to ensure rigorous, well-documented studies. Our overall product stability testing and validation program includes integrity and container closures for package systems, as well as transportation and storage evaluations. The Advanced Therapies unit employs a comprehensive menu of sterility assurance services. Bags, tubing, filters... no matter the product... our expert scientists work with customers to develop successful protocols for single-use systems. We hold experience with BPOG and BPSA protocols, with modified versions of both.

Our team of chemists and toxicologists design studies to meet your needs – from traditional packaging to complex delivery systems that place your device in the combination products spectrum.
• Required integrity testing after each stability and transportation test
• Unmatched capacity for a wide range of temperatures and humidity
• Compliance with FDA guidance for safety evaluation: A must for primary packaging components that are - or may be in direct contact with - the dosage form

CONTACT our experts to design testing programs that meet regulatory requirements for containers, closures, packaging, devices, biologics and combination products.

Stability, performance and container closure: Integrity testing services, capabilities and validations
• Sterile barrier systems, seal strength, integrity and packaging compliance
• Performance under physical and environmental stress
• Aging, expiration date determination
• Compatibility with the product and sterilization process
• Performance, transportation
• Biocompatibility, extractables & leachables
• Material chemical characterization

Technology Platform
• Accelerated and real-time shelf life studies
• Liquid dye immersion with vacuum
• Simulated distribution
• Low pressure / high altitude (LPHA) test
• Drop, compression, concentrated impact and vibration testing

Compliance / Regulatory / Quality
ISO 11607 Intl. Organization for Standardization: Packaging for terminally sterilized medical devices
ANSI American National Standards Institute
AAMI Association for the Advancement of Medical Instrumentation
ASTM American Society for Testing and Materials
ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems
CBER Center for Biologics Evaluation and Research
CDER Center for Drug Evaluation and Research
ISTA International Safe Transit Association
ISTA Thermal Transport Package Testing (Cold-Chain)
USP United States Pharmacopeia
ICH Intl. Conf. on Harmonization: Tech. Requirements for Registration of Pharmaceuticals for Human Use
PDA Parenteral Drug Association Technical Report 27 (TR 27): Pharmaceutical Package Integrity

WuXi Advanced Therapies offers a comprehensive range of analytical testing services to characterize complex biologics, vaccines and advanced therapies. Many of these assays can then be further developed and validated to measure product quality and consistency in lot release and stability testing programs. We provide services for mAbs, rProteins, Peptides, Viral Vaccines, VLP Vaccines, Gene Therapy Vectors (Virus or Plasmid-based), Cellular Therapeutics or Whole Cell Vaccines, as well as Biologic + Medical Device.

Why Us?
• Programs for a wide variety of biologics
• Comprehensive stability study programs
• Development and validation of stability-indicating assays
• Understanding of, and adherence to ICH and regulatory guidelines
• Reference standard characterization

CONTACT US to design and implement comprehensive product stability testing and storage programs to meet regulatory and client requirements

Program Overview
• General characterization
• Purity
• Impurity
• Identity
• Potency
• Safety

Technology Platform
A variety of analytical methods are available including compendial and client specific/custom assays
• Concentration, visual appearance, particulates, pH, osmolality
• SDS-PAGE, SEC-HPLC, IEX-HPLC, CE-SDS, cIEF
• ELISAs, qPCR, Western blotting
• Bioassays, ELISA, IEF-PAGE, cIEF, peptide mapping, sequencing via LC/MS/MS
• Endotoxin, bioburden, sterility/CCIT, virology, mycoplasma

Compliance / Regulatory / Quality
• Stability programs conducted under GMP guidelines
• Individual assays under GMP conditions with quality oversight
• Methods validation according to ICH guidelines
• Q1A(R2) Stability Testing of New Drug Substances and Products
• Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
• Q1B Stability Testing: Photostability Testing of New Drug Substances and Products
• USP Section 1049 Quality of Biotechnological Products: Stability Testing of Biotechnological /

Biological Products
• 21CFR Part 211.166 Federal Code of Regulations, Title 21 Volume 4, Stability Testing

Our history of success translates to confidence for your future analytical development. For virus-based products, vaccines or gene therapy vectors, our decades-long history in virology testing supports stability studies for these type of products. Methods include virus particle or infectious virus titer, IFA and dynamic light scattering for aggregates. DNA or qPCR sequencing can be used for identity testing utilizing our molecular biology expertise.

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Packaging Certification

Price on request

Our overall product stability testing and validation program includes integrity and container closures for package systems, as well as transportation and storage evaluations. The Advanced Therapies unit employs a comprehensive menu of sterility assurance services. Bags, tubing, filters... no matter the product... our expert... Show more »

Our overall product stability testing and validation program includes integrity and container closures for package systems, as well as transportation and storage evaluations. The Advanced Therapies unit employs a comprehensive menu of sterility assurance services. Bags, tubing, filters... no matter the product... our expert scientists work with customers to develop successful protocols for single-use systems. We hold experience with BPOG and BPSA protocols, with modified versions of both.

Our team of chemists and toxicologists design studies to meet your needs – from traditional packaging to complex delivery systems that place your device in the combination products spectrum.
• Required integrity testing after each stability and transportation test
• Unmatched capacity for a wide range of temperatures and humidity
• Compliance with FDA guidance for safety evaluation: A must for primary packaging components that are - or may be in direct contact with - the dosage form

CONTACT our experts to design testing programs that meet regulatory requirements for containers, closures, packaging, devices, biologics and combination products.

Stability, performance and container closure: Integrity testing services, capabilities and validations
• Sterile barrier systems, seal strength, integrity and packaging compliance
• Performance under physical and environmental stress
• Aging, expiration date determination
• Compatibility with the product and sterilization process
• Performance, transportation
• Biocompatibility, extractables & leachables
• Material chemical characterization

Technology Platform
• Accelerated and real-time shelf life studies
• Liquid dye immersion with vacuum
• Simulated distribution
• Low pressure / high altitude (LPHA) test
• Drop, compression, concentrated impact and vibration testing

Compliance / Regulatory / Quality
ISO 11607 Intl. Organization for Standardization: Packaging for terminally sterilized medical devices
ANSI American National Standards Institute
AAMI Association for the Advancement of Medical Instrumentation
ASTM American Society for Testing and Materials
ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems
CBER Center for Biologics Evaluation and Research
CDER Center for Drug Evaluation and Research
ISTA International Safe Transit Association
ISTA Thermal Transport Package Testing (Cold-Chain)
USP United States Pharmacopeia
ICH Intl. Conf. on Harmonization: Tech. Requirements for Registration of Pharmaceuticals for Human Use
PDA Parenteral Drug Association Technical Report 27 (TR 27): Pharmaceutical Package Integrity

WuXi Advanced Therapies offers a comprehensive range of analytical testing services to characterize complex biologics, vaccines and advanced therapies. Many of these assays can then be further developed and validated to measure product quality and consistency in lot release and stability testing programs. We provide services for mAbs, rProteins, Peptides, Viral Vaccines, VLP Vaccines, Gene Therapy Vectors (Virus or Plasmid-based), Cellular Therapeutics or Whole Cell Vaccines, as well as Biologic + Medical Device.

Why Us?
• Programs for a wide variety of biologics
• Comprehensive stability study programs
• Development and validation of stability-indicating assays
• Understanding of, and adherence to ICH and regulatory guidelines
• Reference standard characterization

CONTACT US to design and implement comprehensive product stability testing and storage programs to meet regulatory and client requirements

Program Overview
• General characterization
• Purity
• Impurity
• Identity
• Potency
• Safety

Technology Platform
A variety of analytical methods are available including compendial and client specific/custom assays
• Concentration, visual appearance, particulates, pH, osmolality
• SDS-PAGE, SEC-HPLC, IEX-HPLC, CE-SDS, cIEF
• ELISAs, qPCR, Western blotting
• Bioassays, ELISA, IEF-PAGE, cIEF, peptide mapping, sequencing via LC/MS/MS
• Endotoxin, bioburden, sterility/CCIT, virology, mycoplasma

Compliance / Regulatory / Quality
• Stability programs conducted under GMP guidelines
• Individual assays under GMP conditions with quality oversight
• Methods validation according to ICH guidelines
• Q1A(R2) Stability Testing of New Drug Substances and Products
• Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
• Q1B Stability Testing: Photostability Testing of New Drug Substances and Products
• USP Section 1049 Quality of Biotechnological Products: Stability Testing of Biotechnological /

Biological Products
• 21CFR Part 211.166 Federal Code of Regulations, Title 21 Volume 4, Stability Testing

Our history of success translates to confidence for your future analytical development. For virus-based products, vaccines or gene therapy vectors, our decades-long history in virology testing supports stability studies for these type of products. Methods include virus particle or infectious virus titer, IFA and dynamic light scattering for aggregates. DNA or qPCR sequencing can be used for identity testing utilizing our molecular biology expertise.

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Preclinical Adverse Event Reporting

Price on request

Exceptional Expertise to Support your Specific Preclinical Study Design Needs

Preclinical services for biologics leverage our breadth and unique mix of scientific, technical and regulatory expertise in virology, in-life studies and bioanalytical assays. Our staff experience, established facilities and broad understanding of... Show more »

Exceptional Expertise to Support your Specific Preclinical Study Design Needs

Preclinical services for biologics leverage our breadth and unique mix of scientific, technical and regulatory expertise in virology, in-life studies and bioanalytical assays. Our staff experience, established facilities and broad understanding of advanced therapeutic development make us a global leader in preclinical, toxicology and biodistribution studies. The Advanced Therapies facilities provide necessary suites and laboratories to conduct your critical preclinical studies.

Supporting Development. Improving Success.
Scientific, technical and regulatory experts – with a wide variety of skill sets – are available to assist in all facets of your program, including protocol design, assay development, validation and end-point analysis.
• Extensive experience with enabling studies for investigational new drugs
• Expert guidance in discovery studies for lead identification and GLP program optimization
• Personalized, expert consulting in a rapidly evolving regulatory landscape
• Development and validation cell-based and bioanalytical methods
• On-staff Ph.D. toxicologists, immunologists, molecular biologists, analytical chemists surgeons, veterinarians and board-certified pathologists

CONTACT US to learn more about our comprehensive preclinical testing and discovery services

Program Overview
• Comprehensive preclinical testing
• Discovery research capabilities
• In-vivo proof-of-concept studies
• Animal models and routes of administration (ROA)
• Endpoint analysis capabilities
• Toxicology, tumorigenicity, biodistribution

Technology Platform
• Efficacy and tk/pK studies
• Dose Finding (MTD): Subacute, subchronic, chronic
• Biodistribution: Viral vectors, human cells
• Model development: ESC, iPSC, adult SC, Cell lines
• Design of PCR-based methods for biodistribution studies
• Bioanalytical, analytical, virology, immunology, molecular & cell biology

Compliance / Regulatory / Quality
• GLP and discovery research
• ISO 17025 and AAALAC accredited
• USDFA HCT/Ps registered
• GMP manufacturing of cellular therapies

The Advanced Therapies unit of WuXi AppTec offers unequalled expertise, from preclinical to commercial. As a case in point, our early testing and discovery services cover fine points like feasibility, risk assessment, optimization of transgene expression. And clients can select options for deep sequencing, high-throughput bioanalysis, biomarker analysis, immunogenicity and more.

Facilities and Infrastructure
• Dedicated BSL-2 suites and laboratories
• Radiography / fluoroscopy imaging capabilities
• Formulation and cell culture laboratories
• On-site clinical chemistry
• State-of-the-art animal study rooms and surgical suites

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In vivo Drug Efficacy Testing

Price on request

Exceptional Expertise to Support your Specific Preclinical Study Design Needs

Preclinical services for biologics leverage our breadth and unique mix of scientific, technical and regulatory expertise in virology, in-life studies and bioanalytical assays. Our staff experience, established facilities and broad understanding of... Show more »

Exceptional Expertise to Support your Specific Preclinical Study Design Needs

Preclinical services for biologics leverage our breadth and unique mix of scientific, technical and regulatory expertise in virology, in-life studies and bioanalytical assays. Our staff experience, established facilities and broad understanding of advanced therapeutic development make us a global leader in preclinical, toxicology and biodistribution studies. The Advanced Therapies facilities provide necessary suites and laboratories to conduct your critical preclinical studies.

Supporting Development. Improving Success.
Scientific, technical and regulatory experts – with a wide variety of skill sets – are available to assist in all facets of your program, including protocol design, assay development, validation and end-point analysis.
• Extensive experience with enabling studies for investigational new drugs
• Expert guidance in discovery studies for lead identification and GLP program optimization
• Personalized, expert consulting in a rapidly evolving regulatory landscape
• Development and validation cell-based and bioanalytical methods
• On-staff Ph.D. toxicologists, immunologists, molecular biologists, analytical chemists surgeons, veterinarians and board-certified pathologists

CONTACT US to learn more about our comprehensive preclinical testing and discovery services

Program Overview
• Comprehensive preclinical testing
• Discovery research capabilities
• In-vivo proof-of-concept studies
• Animal models and routes of administration (ROA)
• Endpoint analysis capabilities
• Toxicology, tumorigenicity, biodistribution

Technology Platform
• Efficacy and tk/pK studies
• Dose Finding (MTD): Subacute, subchronic, chronic
• Biodistribution: Viral vectors, human cells
• Model development: ESC, iPSC, adult SC, Cell lines
• Design of PCR-based methods for biodistribution studies
• Bioanalytical, analytical, virology, immunology, molecular & cell biology

Compliance / Regulatory / Quality
• GLP and discovery research
• ISO 17025 and AAALAC accredited
• USDFA HCT/Ps registered
• GMP manufacturing of cellular therapies

The Advanced Therapies unit of WuXi AppTec offers unequalled expertise, from preclinical to commercial. As a case in point, our early testing and discovery services cover fine points like feasibility, risk assessment, optimization of transgene expression. And clients can select options for deep sequencing, high-throughput bioanalysis, biomarker analysis, immunogenicity and more.

Facilities and Infrastructure
• Dedicated BSL-2 suites and laboratories
• Radiography / fluoroscopy imaging capabilities
• Formulation and cell culture laboratories
• On-site clinical chemistry
• State-of-the-art animal study rooms and surgical suites

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In vivo PK/PD Studies

Price on request

Exceptional Expertise to Support your Specific Preclinical Study Design Needs

Preclinical services for biologics leverage our breadth and unique mix of scientific, technical and regulatory expertise in virology, in-life studies and bioanalytical assays. Our staff experience, established facilities and broad understanding of... Show more »

Exceptional Expertise to Support your Specific Preclinical Study Design Needs

Preclinical services for biologics leverage our breadth and unique mix of scientific, technical and regulatory expertise in virology, in-life studies and bioanalytical assays. Our staff experience, established facilities and broad understanding of advanced therapeutic development make us a global leader in preclinical, toxicology and biodistribution studies. The Advanced Therapies facilities provide necessary suites and laboratories to conduct your critical preclinical studies.

Supporting Development. Improving Success.
Scientific, technical and regulatory experts – with a wide variety of skill sets – are available to assist in all facets of your program, including protocol design, assay development, validation and end-point analysis.
• Extensive experience with enabling studies for investigational new drugs
• Expert guidance in discovery studies for lead identification and GLP program optimization
• Personalized, expert consulting in a rapidly evolving regulatory landscape
• Development and validation cell-based and bioanalytical methods
• On-staff Ph.D. toxicologists, immunologists, molecular biologists, analytical chemists surgeons, veterinarians and board-certified pathologists

CONTACT US to learn more about our comprehensive preclinical testing and discovery services

Program Overview
• Comprehensive preclinical testing
• Discovery research capabilities
• In-vivo proof-of-concept studies
• Animal models and routes of administration (ROA)
• Endpoint analysis capabilities
• Toxicology, tumorigenicity, biodistribution

Technology Platform
• Efficacy and tk/pK studies
• Dose Finding (MTD): Subacute, subchronic, chronic
• Biodistribution: Viral vectors, human cells
• Model development: ESC, iPSC, adult SC, Cell lines
• Design of PCR-based methods for biodistribution studies
• Bioanalytical, analytical, virology, immunology, molecular & cell biology

Compliance / Regulatory / Quality
• GLP and discovery research
• ISO 17025 and AAALAC accredited
• USDFA HCT/Ps registered
• GMP manufacturing of cellular therapies

The Advanced Therapies unit of WuXi AppTec offers unequalled expertise, from preclinical to commercial. As a case in point, our early testing and discovery services cover fine points like feasibility, risk assessment, optimization of transgene expression. And clients can select options for deep sequencing, high-throughput bioanalysis, biomarker analysis, immunogenicity and more.

Facilities and Infrastructure
• Dedicated BSL-2 suites and laboratories
• Radiography / fluoroscopy imaging capabilities
• Formulation and cell culture laboratories
• On-site clinical chemistry
• State-of-the-art animal study rooms and surgical suites

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Preclinical Study Design

Price on request

Exceptional Expertise to Support your Specific Preclinical Study Design Needs

Preclinical services for biologics leverage our breadth and unique mix of scientific, technical and regulatory expertise in virology, in-life studies and bioanalytical assays. Our staff experience, established facilities and broad understanding of... Show more »

Exceptional Expertise to Support your Specific Preclinical Study Design Needs

Preclinical services for biologics leverage our breadth and unique mix of scientific, technical and regulatory expertise in virology, in-life studies and bioanalytical assays. Our staff experience, established facilities and broad understanding of advanced therapeutic development make us a global leader in preclinical, toxicology and biodistribution studies. The Advanced Therapies facilities provide necessary suites and laboratories to conduct your critical preclinical studies.

Supporting Development. Improving Success.
Scientific, technical and regulatory experts – with a wide variety of skill sets – are available to assist in all facets of your program, including protocol design, assay development, validation and end-point analysis.
• Extensive experience with enabling studies for investigational new drugs
• Expert guidance in discovery studies for lead identification and GLP program optimization
• Personalized, expert consulting in a rapidly evolving regulatory landscape
• Development and validation cell-based and bioanalytical methods
• On-staff Ph.D. toxicologists, immunologists, molecular biologists, analytical chemists surgeons, veterinarians and board-certified pathologists

CONTACT US to learn more about our comprehensive preclinical testing and discovery services

Program Overview
• Comprehensive preclinical testing
• Discovery research capabilities
• In-vivo proof-of-concept studies
• Animal models and routes of administration (ROA)
• Endpoint analysis capabilities
• Toxicology, tumorigenicity, biodistribution

Technology Platform
• Efficacy and tk/pK studies
• Dose Finding (MTD): Subacute, subchronic, chronic
• Biodistribution: Viral vectors, human cells
• Model development: ESC, iPSC, adult SC, Cell lines
• Design of PCR-based methods for biodistribution studies
• Bioanalytical, analytical, virology, immunology, molecular & cell biology

Compliance / Regulatory / Quality
• GLP and discovery research
• ISO 17025 and AAALAC accredited
• USDFA HCT/Ps registered
• GMP manufacturing of cellular therapies

The Advanced Therapies unit of WuXi AppTec offers unequalled expertise, from preclinical to commercial. As a case in point, our early testing and discovery services cover fine points like feasibility, risk assessment, optimization of transgene expression. And clients can select options for deep sequencing, high-throughput bioanalysis, biomarker analysis, immunogenicity and more.

Facilities and Infrastructure
• Dedicated BSL-2 suites and laboratories
• Radiography / fluoroscopy imaging capabilities
• Formulation and cell culture laboratories
• On-site clinical chemistry
• State-of-the-art animal study rooms and surgical suites

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Project Management

Price on request
Request a quote for more information about this service.

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Protein Characterization

Price on request

Protein Characterization Services

Protein Characterization Services

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Protein Engineering/Directed Evolution

Price on request
Request a quote for more information about this service.

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Protein Production

Price on request

Protein Expression Services

Protein Expression Services

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Protein Expression Screening and Optimization

Price on request
Request a quote for more information about this service.

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Protein Identification

Price on request
Request a quote for more information about this service.

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Protein Purification

Price on request
Request a quote for more information about this service.

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Protein Services

Price on request

Protein Services

Protein Services

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Recombinant Antibody Production

Price on request
Request a quote for more information about this service.

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Recombinant Protein Expression

Price on request
Request a quote for more information about this service.

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Residual Impurity Analysis

Price on request

Process Residual Testing: Superior Detection and Estimation of Process-Related Impurities

Our testing services provide the high-quality analysis required throughout biotherapeutic discovery, development, clinical trials and commercialization. Assays can be transferred, developed, verified, qualified or validated at WuXi... Show more »

Process Residual Testing: Superior Detection and Estimation of Process-Related Impurities

Our testing services provide the high-quality analysis required throughout biotherapeutic discovery, development, clinical trials and commercialization. Assays can be transferred, developed, verified, qualified or validated at WuXi Advanced Therapies, and are run under GMP conditions. For custom assays, technology transfer protocols efficiently move assays from your lab to ours.

Unknowns are Unacceptable
Extractables & Leachables data – along with risk assessment – are critical components of biologics testing programs. E&L data is especially pertinent to regulatory and industry groups, which increasingly use it to support product safety and understand process quality. Regardless of protocol or product, there is one constant: Complete identification is required to understand your product and its potential risks.

Reasons to work with WuXi Advanced Therapies for process residual testing:
• Industry leader with expertise, experience and tools that set us apart to successfully support large biopharma clients with recurring projects
• Full characterization of process-related contaminants or impurities in bulk substance or final product
• Extractables & Leachables (E&L) testing for Single Use Systems (SUS)
• Proprietary database aids identification

CONTACT US for process residual analysis, including analytical, protein A, detergents, antibiotics, growth factors, insulin, host cell protein and media components, among others.

Program Overview
• Residuals testing
• E&L characterization
• Process development & characterization
• Raw materials release testing
• In-process testing

Technology Platform
• Process related residuals, impurities testing and disposable characterization
• Mycoplasma, sterility, virus screen, microbial enumeration, identity assessment
• Residual host cell DNA and DNA sizing
• Host cell protein (HCP), process residuals (BSA, Protein A, etc.)
• Analytical (Identity, purity, concentration)
• Potency / cell-based assays, product titer
• General chemistry tests, LC-MS database – ChemView

Compliance / Regulatory / Quality
• Assays are run under GMP conditions
• Unknowns are unacceptable to the regulatory agencies and to our team
• Risk assessments include calculations of tolerable intakes and margin of safety for each chemical
• Unknowns must be considered the highest risk (e.g., genotoxic, carcinogenic)

To develop a sound study to support safety, you need to understand the risk of your components, including proximity to the final product, duration of contact, contact area, the type of plastic the product is made from and dose & route of exposure to patient. The goal of an E&L Program should be to identify ALL of the potential chemicals that could come out of product, in order proper risk assessment. To do this, you need to understand your product and process, challenge your product to maximize the extractable chemicals, and utilize multiple analytical methods to ensure the full range of chemicals are detected and identified.

Facilities
• State-of-the-art chemistry laboratory

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Residual Solvent Analysis

Price on request

Process Residual Testing: Superior Detection and Estimation of Process-Related Impurities

Our testing services provide the high-quality analysis required throughout biotherapeutic discovery, development, clinical trials and commercialization. Assays can be transferred, developed, verified, qualified or validated at WuXi... Show more »

Process Residual Testing: Superior Detection and Estimation of Process-Related Impurities

Our testing services provide the high-quality analysis required throughout biotherapeutic discovery, development, clinical trials and commercialization. Assays can be transferred, developed, verified, qualified or validated at WuXi Advanced Therapies, and are run under GMP conditions. For custom assays, technology transfer protocols efficiently move assays from your lab to ours.

Unknowns are Unacceptable
Extractables & Leachables data – along with risk assessment – are critical components of biologics testing programs. E&L data is especially pertinent to regulatory and industry groups, which increasingly use it to support product safety and understand process quality. Regardless of protocol or product, there is one constant: Complete identification is required to understand your product and its potential risks.

Reasons to work with WuXi Advanced Therapies for process residual testing:
• Industry leader with expertise, experience and tools that set us apart to successfully support large biopharma clients with recurring projects
• Full characterization of process-related contaminants or impurities in bulk substance or final product
• Extractables & Leachables (E&L) testing for Single Use Systems (SUS)
• Proprietary database aids identification

CONTACT US for process residual analysis, including analytical, protein A, detergents, antibiotics, growth factors, insulin, host cell protein and media components, among others.

Program Overview
• Residuals testing
• E&L characterization
• Process development & characterization
• Raw materials release testing
• In-process testing

Technology Platform
• Process related residuals, impurities testing and disposable characterization
• Mycoplasma, sterility, virus screen, microbial enumeration, identity assessment
• Residual host cell DNA and DNA sizing
• Host cell protein (HCP), process residuals (BSA, Protein A, etc.)
• Analytical (Identity, purity, concentration)
• Potency / cell-based assays, product titer
• General chemistry tests, LC-MS database – ChemView

Compliance / Regulatory / Quality
• Assays are run under GMP conditions
• Unknowns are unacceptable to the regulatory agencies and to our team
• Risk assessments include calculations of tolerable intakes and margin of safety for each chemical
• Unknowns must be considered the highest risk (e.g., genotoxic, carcinogenic)

To develop a sound study to support safety, you need to understand the risk of your components, including proximity to the final product, duration of contact, contact area, the type of plastic the product is made from and dose & route of exposure to patient. The goal of an E&L Program should be to identify ALL of the potential chemicals that could come out of product, in order proper risk assessment. To do this, you need to understand your product and process, challenge your product to maximize the extractable chemicals, and utilize multiple analytical methods to ensure the full range of chemicals are detected and identified.

Facilities
• State-of-the-art chemistry laboratory

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Cell Culture Scale-Up

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Sterile Manufacturing

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Sterility Testing

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• Rapid Sterility Testing: Key to expedited process sterility screening and/or release
• Individual sterility and mycoplasma laboratories
• Sterility, pyrogenicity, endotoxin, microbial enumeration, mycoplasma, bioburden

The Advanced Therapies unit employs a comprehensive menu of sterility assurance services. Bags, tubing,... Show more »

• Rapid Sterility Testing: Key to expedited process sterility screening and/or release
• Individual sterility and mycoplasma laboratories
• Sterility, pyrogenicity, endotoxin, microbial enumeration, mycoplasma, bioburden

The Advanced Therapies unit employs a comprehensive menu of sterility assurance services. Bags, tubing, filters... no matter the product... our expert scientists work with customers to develop successful protocols.

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T-cell Engineering

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Toxicology

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Our staff experience, established facilities and broad understanding of advanced therapeutic testing make us a global leader in toxicology studies. Advanced Therapies toxicologists design studies to meet your needs – from traditional packaging to complex delivery systems that place your device in the combination products... Show more »

Our staff experience, established facilities and broad understanding of advanced therapeutic testing make us a global leader in toxicology studies. Advanced Therapies toxicologists design studies to meet your needs – from traditional packaging to complex delivery systems that place your device in the combination products spectrum.
• Sub-acute, subchronic and chronic toxicology
• On-staff Ph.D. toxicologists

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Vaccine Production

Price on request

WuXi Advanced Therapies offers viral vector manufacturing�with the WuXi Hyper PRO(tm) Platform, a closed, adherent production system suitable for lentivirus, and adaptable to AAV vectors. The WuXi Hyper-PRO™ system features favorable predictability and time to clinic, with GMP vectors in 7-8 months. Custom product development and... Show more »

WuXi Advanced Therapies offers viral vector manufacturing�with the WuXi Hyper PRO(tm) Platform, a closed, adherent production system suitable for lentivirus, and adaptable to AAV vectors. The WuXi Hyper-PRO™ system features favorable predictability and time to clinic, with GMP vectors in 7-8 months. Custom product development and manufacturing capability is available, and we support commercial manufacturing.

We've been manufacturing GMP grade rAAV vectors �for early-phase clinical trials since Q4 2015, including experience with triple-transfection and viral-mediated �production systems.

WuXi Advanced Therapies recognized a need for lentiviral vectors, and invested in process. In parallel, we worked to reduce time delays, program hurdles and risks with batch records, SOPs, and materials. Why Lentivirus Vectors?

  • Accommodate large transgenes (>8kb)
  • Efficient gene transfer
  • Infect dividing and non-dividing cells
  • Stably integrate into target cell genome for long term expression
  • Multiple applications for therapy (ex-vivo/in-vivo)
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Vaccine Testing Services

Price on request

Trusted Leadership in Testing Programs for Viral Based Therapies

The Advanced Therapies vaccine testing program comprises a full spectrum of services to speed viral-based therapeutics from discover to commercialization. We offer testing programs for viral, VLP, whole cell, protein, peptide and DNA-based vaccines. With many... Show more »

Trusted Leadership in Testing Programs for Viral Based Therapies

The Advanced Therapies vaccine testing program comprises a full spectrum of services to speed viral-based therapeutics from discover to commercialization. We offer testing programs for viral, VLP, whole cell, protein, peptide and DNA-based vaccines. With many years of experience in providing fully integrated vaccine biosafety testing programs, our team has backed numerous, effective projects. Advanced Therapies can develop or perform technology transfer from the Sponsor for biosafety and analytical methods required to release product lots. Importantly, we test for replication-competent virus that may have been produced through recombination during preparation and ex vivo patient treatment with retroviral-based gene therapies and gene-mediated cell therapies.

We Provide Confidence for your Viral Therapy Testing Needs
• Our quality systems have been audited and accepted by regulatory authorities worldwide
• Trusted leadership in viral bank characterization
• Comprehensive portfolio of testing services and assays to support AAV and Lenti-based programs
• Decades of viral vector testing experience
• We cover all required testing for each manufacturing step

CONTACT US to learn more about our full line-up of testing services for viral-based therapies.

In addition to extensive testing common to all our bio-based therapeutics, we offer detailed services and technologies specific for viral-based therapies. Safety and characterization assays for gene-mediated cell therapies cover master cell bank, working cell bank, end of production cells, vector-containing supernatant and ex vivo transduced cells.
• Viral product stability
• Viral identity, titer and genetic characterization
• Viral clearance / inactivation
• Adventitious virus detection
• Detection of viral process-related impurities
• Adeno-associated virus (AAV)
• General virus screens and Species-specific virus tests
• Replication-Competent Retrovirus (RCR) and Lentivirus (RCL) Testing

Compliance / Regulatory / Quality
• GMP testing programs
• USP testing services, assays
• Successful support of BLA and IND applications
• ICH validation
• All regulatory authority-mandated assays for worldwide biosafety analysis of viral stocks
• FDA and EMA framework for safety and characterization of viral vector-based products

An Advanced Therapies Success Story: Leadership in AAV & Lentivirus Testing
Viral vectors are effective vehicles for delivering the next generation of cell and gene therapies. Due to the complexity of viral vector systems, the development process, and the intricacies of ex vivo or in vivo patient administration, ensuring the overall safety and the full characterization of these therapeutics is paramount. From master cell bank creation through lot release, we provide clients a complete set test options to ultimately protect patients.

Facilities
• Multiple suites
• World-class laboratories
• Comprehensive equipment portfolio

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Viral Clearance Assays

Price on request

Viral Clearance Validation: Offering a Platform to Drive Higher Log Reduction Values

Not all virus preparations have the same titer or purity. By providing consistency between multiple runs, studies and projects, the WuXi Advanced Therapies toolbox can help your viral clearance initiatives succeed. For decades, we’ve been at... Show more »

Viral Clearance Validation: Offering a Platform to Drive Higher Log Reduction Values

Not all virus preparations have the same titer or purity. By providing consistency between multiple runs, studies and projects, the WuXi Advanced Therapies toolbox can help your viral clearance initiatives succeed. For decades, we’ve been at the forefront of viral clearance studies – no one has more experience or a more highly developed program. We control VC studies better to optimize results, offering a scientifically sound approach for robust virus clearance. Our history of global regulatory perfection is the absolute industry standard. Scientifically sound study designs save time, materials and money by reducing the number of process steps evaluated while maximizing the log reduction values obtained for those steps. You can have confidence in methods that decrease assay variability, ensure reproducibility, and meet global regulatory needs.

Viral Clearance Studies from an industry leader with unmatched expertise across a wide range of products.
• Proprietary process for the highest purity virus stocks on the market
• Impeccable regulatory track record
• Study designs that result in higher LRVs
• Largest capacity in the industry
• Remote studies can save you time, money
• Continuous chromatography processing options
• Highest purity virus grades improve filtration and other purification steps
• Benefits of Viral Plaque Assay over TCID50

CONTACT our experienced staff to help design and execute your entire study, working side-by-side with you each step of the way.

Program Overview
• Virus inactivation, removal and cleaning
• High titer virus stocks for VC studies
• Ultra-purified virus stock
• Data mining services with multiple search criteria
• Database with >3500 different studies, 20,000 data points and 3 decades of LRVs
• Extensive library of inactivation and removal process steps

Technology Platform
• Heat, pH extremes, solvents, detergents, irradiation, sterilization or high-energy light for viral inactivation
• Column chromatography and filtration for virus removal
• Kinetic of inactivation and coupon studies for cleaning
• Chromatography, ultracentrigugation and proprietary methods for Ultra-Purified viral stocks
• Large-Volume Testing + Virus Plaque Assay + Total Viral Load Approach = Higher Log Reduction Value + More Consistent Data + Better Reliability
• Supporting mAbs, rProteins, tissue & plasma-derived, gene therapy vectors, vaccines, raw materials and devices

Compliance / Regulatory / Quality
• Phase 1-3, BLA
• R&D backing for IND or Phase IV
• 510K submissions
• Marketing Authorization
• 0 studies rejected by global regulatory authorities

Your Challenges, Our Solutions: The Viral Plaque Assay
Inadequate log reduction values can raise regulatory questions, but designing a robust viral clearances study takes technical horsepower, and early-stage studies don’t always predict final process results. Using advanced, globally accepted testing approaches, our team of experts will design studies that produce better results – with higher log-reduction values for your process. For example, of the several ways to detect virus, our preferred method is the Viral Plaque Assay, which detects the presence of plaque-, foci- or syncytium-forming units. Viral Plaque Assay offers higher sensitivity, quantitative results and easier scale-up compared to TCID50, another approach available in the industry. Shorthand for Tissue Culture Infectious Dose (50) End Point Titration, TCID50 measures the percent of cultures infected (Quantal).

Facilities
• Expanding and flexible capacities
• Back-ups available as needed to keep your study on-track
• Platform development
• Investing in growth. Planning for the future.

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Virus Characterization

Price on request
Request a quote for more information about this service.

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Virus Production

Price on request

WuXi Advanced Therapies offers viral vector manufacturing with the WuXi Hyper PRO(tm) Platform, a closed, adherent production system suitable for lentivirus, and adaptable to AAV vectors. The WuXi Hyper-PRO™ system features favorable predictability and time to clinic, with GMP vectors in 7-8 months. Custom product development and... Show more »

WuXi Advanced Therapies offers viral vector manufacturing with the WuXi Hyper PRO(tm) Platform, a closed, adherent production system suitable for lentivirus, and adaptable to AAV vectors. The WuXi Hyper-PRO™ system features favorable predictability and time to clinic, with GMP vectors in 7-8 months. Custom product development and manufacturing capability is available, and we support commercial manufacturing.

We've been manufacturing GMP grade rAAV vectors for early-phase clinical trials since Q4 2015, including experience with triple-transfection and viral-mediated production systems.

WuXi Advanced Therapies recognized a need for lentiviral vectors, and invested in process. In parallel, we worked to reduce time delays, program hurdles and risks with batch records, SOPs, and materials. Why Lentivirus Vectors?

  • Accommodate large transgenes (>8kb)
  • Efficient gene transfer
  • Infect dividing and non-dividing cells
  • Stably integrate into target cell genome for long term expression
  • Multiple applications for therapy (ex-vivo/in-vivo)
Show less

ic

Virus Purification

Price on request
Request a quote for more information about this service.

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