HCT/P Sterility Assurance and Lot Testing
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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.
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.
Other Custom Services
Additional customized studies that complement a tissue testing program, including biocompatibility testing and cell-based potency assays.