Cell Therapy products are a novel approach to therapeutic intervention which use living cells to treat diseases and conditions. Bioanalytical support strategies for this modality are continuing to evolve as we gain an improved understanding of their unique considerations and as new regulatory guidelines are released around this novel drug modality.     

BioAgilytix’s Cell Therapy Experience

BioAgilytix has significant scientific expertise and resources for supporting cell therapy products. As of 2023, BioAgilytix has partnered with our clients to support bioanalytical testing for over 80 individual cell therapy programs, including two that have received FDA-approval. We have expertise with a variety of cell therapy programs including:

Bioanalytical Assay Services for Cell Therapy Programs 

Our scientific teams design and implement analytical methods in support of cell therapy programs with the appropriate level of regulatory oversight from nonregulated to GxP compliant methods for preclinical and clinical testing. Some of the services commonly provided for our cell therapy clients are:

  • Nonclinical Biodistribution (PCR)
  • Pharmacokinetics/Persistence (Flow cytometry or PCR)
  • Anti-CAR Antibody Detection (ADA or NAb)
  • Anti-Cas9 Antibody Detection
  • Replication Competent Lentivirus (RCL; PCR-based)   
  • Cellular Immunogenicity (ELISpot and/or Flow cytometry)
  • Biomarkers

Our Expertise in Cell Therapy Bioanalysis 

BioAgilytix continues to stay at the forefront of this ever changing bioanalytical landscape. Visit our scientific insights to view content related to cell therapy from blogs and publications to webinars and videos:

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