Potency Assays

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Potency Assays

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    • Home
    • About
    • Blog
    • Guidances
    • References
    • Conferences
    • Vaccine Resources
  • Home
  • About
  • Blog
  • Guidances
  • References
  • Conferences
  • Vaccine Resources

Regulatory Links

Center for Biologics Evaluation and Research

CBER

The International Council for Harmonisation

ICH - Quality Guidelines

Selected Guidance Documents

Guidance for Industry Potency Tests for Cellular and Gene Therapy Products (2011) (FDA)

Cell & Gene Therapy Products

Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens; Draft Guidance for Industry (2023) (FDA)

Monoclonal Antibodies

Considerations for Plasmid DNA Vaccines for Infectious Disease Indications (2007) (FDA)

Plasmid DNA

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