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HCT/P Sterility Assurance and Lot Testing

Tissue & Biologics Sterility Assurance and Lot Testing

With over 25 years of experience in biologics and tissue testing, we understand the critical role of reliable results and dependable, quick turnaround times in releasing your products. Our team at WuXi AppTec will guide you through the unique testing challenges, from designing, executing, documenting, and reporting

Quality Control and Ongoing Product Testing 

We offer a wide range of expertise in all areas of quality testing used for biologics, processed tissue, and tissue-based products, including the following.

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

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.

In Vivo Small Animal Model

Other Custom Services
Additional customized studies that complement a tissue testing program, including biocompatibility testing and cell-based potency assays.