HCT/P Sterility Assurance and Lot Testing
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Medical Device Testing Services Catalog
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.
Bioburden
Endotoxin (LAL)
Sterility
Microbial Identification
Residual Moisture
Residual Calcium
Environmental Monitoring
Water Quality
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.
Other Custom Services
Additional customized studies that complement a tissue testing program, including biocompatibility testing and cell-based potency assays.