WuXi AppTec provides the most comprehensive program of testing services in the U.S. for processed tissue and tissue-based products.
Testing services include:
Bacterial and Viral Inactivation Studies
Studies are performed on human and animal tissues.
Including bioburden, sterility, residual moisture, package testing and accelerated aging.
DBM Lot Release Assays (cGMP)
Osteoinductivity (in-vitro and in-vivo studies),
endotoxin (LAL), and calcium residuals.
Including validation of sterilization/decontamination procedures; and process change validations.
cGMP Contract Services for Device, Combination and Tissue Products
WuXi AppTec offers unique cGMP processing services for device, combination, and tissue products that require processing in a controlled environment. Our exceptional expertise, combined with our advanced facility and highly trained staff, ensures that we can provide comprehensive capabilities – from proof of concept to scale-up for product release.
- Aseptic processing
- Assembly and final packaging
- Method optimization
- Commercial-scale production
- Feasibility/Pilot projects
Processing is conducted in ISO Class 7 (Class 10,000) laboratories operating under strict GMP compliance in positive-pressure suites. Laboratories are HEPA filtered, continuously monitored and alarmed. Validated systems and procedures ensure the highest product quality, procedures, and process change validations.