Development of Potency Assays for vaccines and anti-infective biologics can present a unique set of challenges. As the human immune system is complex, frequently the full mechanism of protection is not known, so best judgment must be used to select a mechanism for a representative potency assay. This is particularly true for novel vaccine technology (e.g., mRNA, nanoparticles) and pandemic response, both of which have occurred in the last few years. The talks in this session will provide insight into the approaches of multiple teams to address these challenges, including use of modern potency techniques where feasible.
Key questions to address:
1. How to select the assay format: e.g. in vitro vs. in vivo?
2. What is the minimum requirement for correlation of in vitro and in vivo data?
3. For genetic vaccines, can in vitro expression be assumed to reflect immunogenicity?
4. For new vaccine technology, applied in an established space, such as influenza, how best to introduce modern potency assay techniques?
5. Given the challenge of strain updates and multivalent strategies, what approaches can be taken to “platform” release methods so that assays for new strains can be quickly validated?
6. What lessons from efforts undertaken to rapidly respond to the pandemic may be applied to other programs?
Yana Miteva, Pfizer Inc.
In-vitro Expression Assay (IVE) for Potency Expression of mRNA Vaccine Product
Brian Meyer, Merck & Co. Inc.
Development of a Reporter Cell Line and Assay for Merck’s Ebola Vaccine (rVSV-ΔG-ZEBOV-GP)
LeeAnn Machiesky, AstraZeneca
EVUSHELD: Delivering Bioassay Methods and Critical Regents Under Highly Accelerated Timelines from Clinical to Commercial Phases