Cell and Viral Bank Characterization

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A successful characterization program has many essential elements, including identity and detection of micro-organisms and mycoplasma. The most highly customized element is the detection of adventitious virus. WuXi AppTec is the clear leader in this field, with exceptional expertise and over 20 years of experience.

Cell Line Characterization Experience

  • Complete assay panels performed for hundreds of cell/viral banks and allogeneic/autologous cell therapy products.
  • Strong track record for supporting IND, BLA and market approvals by regulatory agencies worldwide.
  • Senior staff that serves on industry task forces to remain current on regulatory policies.

Program Features

  • Over 50 cell lines of human and animal origin and over 60 human and animal viruses available as positive controls.
  • Over 40 viral PCR probes and over 100 PCR assays developed and implemented to assess potential virus contamination.
  • Expert advice/consulting on worldwide regulatory requirements.
  • Advising on strategy and performance of cell line characterization studies, and consulting on full program of biosafety testing.
  • Custom assays developed for unique cell lines and viruses as needed.
  • Dedicated virology, molecular biology, cell biology, and analytical labs of over 21,000 square feet.