When Comparable Does Not Mean Equivalent: Designing Analytical Comparability Studies That Withstand Regulatory Scrutiny in ex vivo Lentiviral Gene Therapy

• Framing comparability as characterization, not equivalence, when a process change is expected to improve the product
• Anchoring acceptance criteria to the clinical therapeutic window rather than assay variability alone
• Separating dose-finding from formal assessment to keep pre-specification auditable under regulatory scrutiny; using Type C meetings to align before executing

Speakers:

Ian Bayles

Analytical Assay Development Manager & Head of Quality Control

Expression Therapeutics LLC