Services for Tissue-Based Products

Testing Services

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.

Quality Testing

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.

Custom Studies

Including validation of sterilization/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.