Flow Cytometry Services

Flow Cytometry is a powerful tool for immunological research and is a critical component in many drug development pipelines. The information below is just a brief snapshot of how flow cytometry can be used; but no matter where you are in the process, we have services that can help!

Discovery:

• Investigate Bioactivity, Dose Response, and/or Immunogenicity

Preclinical:

• Proof of Concept
  • Characterization ^{2, 5, 9}
  • Efficacy, Response Profile, & Activity ^{2, 3, 7, 8}
  • Mechanism of Action ^{2, 5}
  • Stability and Viability (Cellular Therapies) ⁵
• Safety
  • Biological Activity/Immunogenicity (affect to host phenotype, T-cell proliferation, B-cell activation, potency) ^{1, 3, 4, 6, 7, 8, 9}
  • Identity (phenotype of Cellular Therapies) ^{2, 5, 7, 8}
  • Impurities (IIRMIs) ⁴
  • Pharmacodynamics ¹
  • Receptor Occupancy ¹
  • Receptor Binding, Affinity, Cross Reactivity ^{1, 9}

Clinical:

• Persistence (phenotype) and Proliferation of Cellular Therapy ⁷
• Immunogenicity of Cellular Therapies ⁷

CMC Manufacturing:

• Product Comparability / Bridging Studies (activity and potency) ^{2, 9}
• In-process testing for Cellular Therapies (viability, cell number, phenotype, receptor expression) ⁷
• Stability and Viability of Cellular Therapies ^{7, 8}
• Lot Release (Alloreactivity, Immunogenicity) ⁷

Referenced Guidance Documents:

1. S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
2. Preclinical Assessment of Investigational Cellular and Gene Therapy Products
3. Human Gene Therapy Products Incorporating Human Genome Editing
4. Immunogenicity Assessment for Therapeutic Protein Products
5. Potency Tests for Cellular and Gene Therapy Products
6. Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products
7. Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products
8. Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
9. Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use