Concurrent Session: Release Assay Qualification Validation 101
Saturday, September 9, 2023 08:00 AM - 09:00 AM
335 AB
Chair
Ashley Krull, PhD, The Ohio State University, USA
Speakers
Melba Marie Page, PhD, Moffitt Cancer Center, USA – What’s in a Validation: Words of Wisdom for PCR and Flow Cytometry Assay
Brigitte Senechal, PharmD, CP, PhD, Memorial Sloan Kettering Cancer Center, USA – Navigating clinical development and analytics in view of emerging regulations for CGTs
Scott Jones, PhD, BioBridge Global, USA – Importance of a robust analytical control strategy in validating cell and gene therapy testing assays
Discuss best practices for validating qPCR and flow cytometry assays, particularly for novel CAR T cell products or other in-house developed products.
Session Objectives
Ashley Krull, PhD, The Ohio State University, USA
Speakers
Melba Marie Page, PhD, Moffitt Cancer Center, USA – What’s in a Validation: Words of Wisdom for PCR and Flow Cytometry Assay
Brigitte Senechal, PharmD, CP, PhD, Memorial Sloan Kettering Cancer Center, USA – Navigating clinical development and analytics in view of emerging regulations for CGTs
Scott Jones, PhD, BioBridge Global, USA – Importance of a robust analytical control strategy in validating cell and gene therapy testing assays
Discuss best practices for validating qPCR and flow cytometry assays, particularly for novel CAR T cell products or other in-house developed products.
Session Objectives
- Describe regulations/best practices around GMP release assay validation;
- Describe the elements included in a standard flow cytometry and PCR assay validation;
- Describe the elements of a robust analytical control strategy.
Ashley Krull PhD
Associate Director, Cell Therapy Manufacturing and Engineering
The Ohio State University
Chair
Associate Director, Cell Therapy Manufacturing and Engineering
The Ohio State University
Chair
Melba Marie Page PhD
Analytical Laboratory (QC) Manager
Moffitt Cancer Center and Research Institute
Speaker
Analytical Laboratory (QC) Manager
Moffitt Cancer Center and Research Institute
Speaker
Brigitte Senechal PharmD, CP, PhD
Head of QC Analytics for Qualification, Validation, and Clinical Release
Memorial Sloan Kettering Cancer Center
Speaker
Head of QC Analytics for Qualification, Validation, and Clinical Release
Memorial Sloan Kettering Cancer Center
Speaker