Testing & cGMP Manufacturing for Combination/Tissue Products for Combination/Tissue Products
Tissue-Based Products
WuXi AppTec provides the most comprehensive program of testing services in the U.S. for processed tissue and tissue-based products. Services include:
- Bacterial and Viral Inactivation Studies - Studies are performed on human and animal tissues.
- Quality Testing - Including bioburden, sterility, residual moisture, package testing and accelerated aging.
- DBM Lot Release Assays (cGMP) - Osteoinductivity (in vitro and in vivo) and endotoxin (LAL).
- Custom Studies - Including: validation of sterilization and decontamination procedures; and process change validations.
Aseptic Processing:
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.
Capabilities
- Aseptic processing
- Assembly and final packaging
- Method optimization
- Commercial-scale production
- Feasibility/Pilot projects
Facility
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.