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

lot release programs

WuXi AppTec has over 20 years of experience with safety testing programs designed to rapidly enter clinical trial phases or to expedite commercial product lot release, in accordance with worldwide regulatory agencies.

Our uniquely broad menu of services provides manufacturers with a “single-source solution” to support their quality (QA and QC) programs. Services include: assay development, assay technical transfer, and assay qualification and validation.

Lot Release Program Assays

WuXi AppTec’s lot release program offers a comprehensive selection of assays (GLP or GMP) for these standard stages in the manufacturing process:

  • Raw Materials Testing
  • In-Process Testing
  • Unprocessed Bulk Product Testing
  • Purified Bulk Product Testing
  • Final Product Testing

Lot Release Experience

  • Thousands of commercial product lots have been released with our virus and mycoplasma detection assays.
  • Comprehensive release programs – that include safety, potency and analytical assays – have been achieved for worldwide regulatory acceptance for hundreds of different products.
  • WuXi AppTec has both developed and validated a wide variety of in vivo, in vitro and PCR virus detection assays.
  • Extensive experience in customer-specific assays, including GMP testing with C of A release statements.

Program Features

  • Scheduling flexibility and the option of expedited testing programs that can offer a true reduction in turnaround times.
  • Over 60 human and animal viruses available as positive controls, adapting easily to thousands of different in vitro tests.
  • Over 50 cell lines of human and animal origin can create thousands of combinations for detection of viruses.
  • Over 40 viral PCR probes and over 100 PCR assays developed and implemented to assess potential virus contamination.
  • Unique cell-based and infectivity assays developed and validated per client or regulatory-driven requests.