Optimization of a mRNA vaccine potency assay platform for global use

Building on existing potency assay development experience, PATH will optimize potency and transfection methods for application to monovalent and multivalent SARS-CoV-2 vaccines.

Project status

66% Completed

Industry Need

Potency assays assess the functional integrity of a target antigen to ensure the final drug product performs consistently in commercial lots as it did in the clinical trial lots.
Existing mRNA potency assays require complex quantification methods such as flow cytometry that are not widely adaptable to routine use by low- and middle-income country (LMIC) manufacturers or National Regulatory Agency (NRA) laboratories.

Solution

PATH proposes to use existing reagents and experience in potency method development for global use to optimize mRNA vaccine potency methods for both monovalent and multivalent SARS-CoV-2 vaccines.

Developing mRNA potency methods using the same platform for monovalent and multivalent products will allow for easy application by vaccine manufacturers in LMIC settings and control labs.
Using well-characterized reagents and generating detailed protocols will ensure consistency between testing sites and standardization of measurements going forward/
Demonstrating a platform approach to mRNA potency for SARS-CoV-2 vaccines supports use of a similar potency approach for future vaccine candidates against other targets such as HIV or respiratory syncytial virus.

Outcomes and Impacts

Identify critical parameters for cell culture transfection and establish specification criteria to ensure consistent antigen production

Optimize the mRNA transfection process to ensure standardization of antigen expression in selected cell lines

Optimize ELISAs for quantification of monovalent and multivalent vaccine antigens

Updates, Related Publications, and Deliverables

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Project Lead

PATH Center for Vaccines Innovation & Access