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
Osteoinductive (OI) Lot Release Assays (cGMP)
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.
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
Liquid Chemical Sterilization
Gas / Plasma / CO2 Processes
Kinetics of Inactivation
Quality Control and Ongoing Product Testing
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