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Services for Tissue-based Products

WuXi AppTec Laboratory Testing Division Medical Device Platform offers a comprehensive program of services for tissue-based products – built on our unequaled experience and expertise.

To support product development through commercialization of your tissue based product, our testing transitions seamlessly through each phase. We offer viral inactivation studies, efficacy studies, and lot release testing to support the product from development through commercialization.

Tissue-based Product Testing

Osteoinductivity (In Vitro)
In Vitro assays can be used to estimate the potential osteo-inductivity of demineralized bone matrix (DBM) as a screening tool for raw materials and final product or as an alternative to animal testing. Two platforms are available: the alkaline phosphatase assay and the BMP (bone morphogenic protein, -2, -4 or-7) ELISA assays.

Osteoinductivity (In Vivo)
In Vivo assays in nude mice or rats are used to definitively prove the ability of a DBM product to induce ectopic bone formation. The study is performed by intra- or inter-muscular implantation of product followed by histopathology.

For over 25 years, WuXi AppTec has provided proven performance at all levels of viral clearance studies.

Our extensive expertise, unparalleled suite capacity, comprehensive database mining and collection of ultra-pure, high-titer virus stocks make us the clear industry leader.

Processes Experience
Our experience spans a broad range of different processes, including:

Inactivation

  • Heat / Pasteurization
  • Low and High pH
  • Solvent / Detergent
  • Irradiation
  • Sterilization
  • High-Energy light
  • Alcohols
  • Disinfectants
  • Liquid Chemical Sterilization
  • Gas / Plasma / CO2 Processes

Cleaning

  • Kinetics of Inactivation
  • Coupon Studies
WuXi Medical Device Platform has a wide range of expertise in all areas of quality testing used for processed tissue and tissue-based products. The tests listed below are highlighted in detail within each section noted.

Microbiology

  • Bioburden
  • Endotoxin (LAL)
  • Sterility
  • Microbial Identification

Chemistry

  • Residual Moisture
  • Residual Calcium

Validation

  • Environmental Monitoring
  • Water Quality

Package Testing

  • Package Testing
  • Accelerated Aging
  • Validation of Sterilization Procedures
  • Validation of Decontamination Procedures
  • Process Change Validations
Other Custom Services
Additional customized studies that complement a tissue testing program, including biocompatibility testing and cell-based potency assays.

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