U.S. Biologics, Advanced Therapies & Medical Devices Manufacturing and Testing

supply chain assessments

Raw materials are often the root cause of manufacturing contamination events. WuXi AppTec’s experts can assist you in assessing your supply chain and developing testing programs not only to detect potential viral and microbial adventitious agents within your raw materials but also to help prevent contamination from a wide variety of critical manufacturing components and reagents.

Experience in Supply Chain Assessments / Raw Materials Testing

WuXi AppTec has over 20 years’ experience in testing for viral and microbial contaminants.

  • Thousands of raw materials tested under GLP and GMP.
  • Over 50 cell lines and 60 viruses available as indicator cell lines or positive controls for detection of adventitious agents.
  • Over 80 PCR assays developed for the detection of specific adventitious or contaminating viruses.
  • Next-generation detection methods (AgentID™/AgentScreen™) & Bioinformatics
  • Shipping study validations performed as part of supply chain analysis.
  • Risk Assessments & Raw Materials Evaluations

Program Features

  • Testing for animal-derived and other adventitious viruses.
  • Fully-equipped, state-of-the-art virology, microbiology, mycoplasma and analytical labs.
  • Established protocols for GMP suite cleaning validations and environmental monitoring.
  • Rapid response to and custom assays developed for new threats or specific environmental isolates of concern.
  • Performance and writing of risk assessments for raw materials and process step control programs.
  • Access to industry-leading regulatory, quality or CMC consultants.