For combination products that require aseptic processing, WuXi AppTec has a long track record of providing these specialized manufacturing services. In addition to the advantages offered by WuXi AppTec’s flexible facilities, knowledgeable staff and years of experience in product development, our clients have found that partnering with us allows them to consolidate their manufacturing and testing needs, which shortens timelines, reduces total cost of development and manufacturing, and improves the quality of their overall process.
cGMP Contract Services for Combination, Device, and Tissue Products
WuXi AppTec offers unique cGMP processing services for combination, device, 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.