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The following literature – in PDF format available for viewing or downloading – provides information regarding services for biopharmaceuticals/cellular therapeutics, medical devices, tissue-based/combination products, and pharmaceuticals.

 

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WuXi AppTec Company Overview

 

WuXi AppTec's Global Capabilities 

 

Biopharmaceuticals / Cellular Therapeutics 

     Introductions / Overviews

          Protein Therapeutics: Reducing Time to Clinic     

          Cellular Therapeutics - Contract GMP/GTP Manufacturing and Testing Services

    

    Cell Banking

          Cell Banking Under GMP Guidelines 

 

     Manufacturing

          Protein Therapeutics Manufacturing Services – cGMP Manufacture and Fill

          Protein Therapeutics Manufacturing Services - Process Development Capabilities 

 

     Testing

          Analytical Services

          Controlled Environments Testing

          Flow Cytometry Assays

          Gene Therapy Testing Services

          Inactivation/Clearance Validation Studies

          Lot Release and Raw Materials Testing

          Method References for Microbiology, Chemistry & Package Testing

          Microbial Identifications

          Mycoplasma Testing for Biologics

          Recombinant Protein / Monoclonal Antibody Biosafety Testing

          Residual DNA Testing

          Stability Studies - Storage and Testing Programs

          Sterility Testing for Biologics

          Vaccine Safety Testing Services 

 

          Toxicology Services

          Biodistribution and Expression Analysis

          Histology + Pathology

          In-Life/Toxicology Services - WuXi AppTec's Facilities

          Toxicology Services: Discovery and Safety Studies 

 

Medical Devices  

    Testing

             Antimicrobial Testing Services for Medical Devices and Industrial Products 

           Antimicrobial Efficacy - A Validated In Vivo Model for Device Implants

           Biological Evaluation of Medical Devices

           Chemical Testing Services for Medical Devices

           Controlled Environments Testing

           Custom Microbial Studies

           Inactivation/Clearance Validation Studies

           Japanese-Compliant Testing 

           JMHLW to ISO Testing Comparison [chart]

           Lot Release and Raw Materials Testing

           Method References for Microbiology, Chemistry & Package Testing

           Microbial Identifications

           Murine Local Lymph Node Assay (LLNA)

           Physical Testing Services for Medical Device Packaging and Products

           Reusable Medical Devices - Validation of Cleaning and Sterilization Processes

           Sterilization Validation Programs 

 

           Toxicology / Biocompatibility / In-Life Services

           Biocompatibility/Safety Testing for Medical Devices

           Biodistribution and Expression Analysis

           Cardiovascular Studies

           Histology + Pathology

           In-Life Services - Custom Medical Device & Materials Testing

           In-Life/Toxicology Services - WuXi AppTec's Facilities

           Orthopedic Implant Studies

           Toxicology Services: Discovery and Safety Studies

 

 

Tissue-Based Products / Combination Products  

     Manufacturing 

           Aseptic Processing: cGMP Contract Services for Device, Combination and Tissue Products

  

     Testing

           Combination/Convergent Technology Products [Testing Services] 

           Controlled Environments Testing

           Lot Release and Raw Materials Testing

           Processed Tissue and Tissue-Based Products Testing 

           (See also Medical Device and Biopharmaceutical listings above for other related testing

           capabilities)     

 

 

 Pharmaceuticals

            Analytical Development Services

            Analytical Supporting Services

            Bioanalytical Services

            Discovery Biology Services

            Discovery Chemistry Services

            DMPK and ADMET Services

            Pharmaceutical Development Services

            Process Chemistry and Scale Up Services

            Research Manufacturing Services