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Cell & Gene Therapy Bulk Harvest Release Testing

Bulk lot release testing is critical to unlock the potential of new gene therapies and gene-modified cell therapies

To unlock the potential of gene therapies and gene-modified cell therapies, our testing services often play a critical role in helping biomanufacturers ensure the identity, potency, and/or safety of the unpurified bulk, raw materials, cell banks, virus banks, and plasmids that are used in production of their final products.

We offer cGMP-compliant bulk harvest release testing support for cell and gene therapies, including those that utilize:

Illustration of adeno-associated vector

AAV

Illustration of lentivirus

Retrovirus/ Lentivirus

Illustration of adenovirus

Adenovirus

Gene Therapy Testing for Unprocessed and Purified Bulk Harvest

Testing of unpurified bulk, which may include transfected producer cells, should include verification of identity, and may involve confirmation of the gene of interest, determination of viral titer, and confirmation of the absence of replication competent virus. Tests for microorganisms (e.g., bacteria, fungi, and mycoplasma) are appropriate for this material, as are broad specificity assays for adventitious viruses.

Our bulk harvest biosafety and characterization testing packages include:

  • Sterility
  • Mycoplasma detection
  • Adventitious virus and virology testing, including quantification of retrovirus-like particles
  • Identity
  • Infectious titer
  • Empty/full capsid analysis
  • Replication-competent virus

In addition, our experts can help bring your therapy to the clinic and beyond with regulatory and technical support; advice on regulatory strategies; data review and evaluation; report writing and technical support; as well as responses to regulatory authorities.

Related Product Resources

White Paper: Accelerating the Time to Market of Gene Therapies through use of a Platform Approach to Characterization and Safety Testing
Poster: Unlocking the potential of viral vectors through functional titer assays
Poster: Testing Approaches For Virus Vectors Used In Gene Therapy: Novel Methods And Regulatory Expectations
Poster: A Viral Safety Strategy for Gene Therapy Viral Vectors
Webinar: Biosafety in Gene Therapy: Applying the Latest Regulatory Guidance for RCL Testing

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