Development of mRNA manufacturing for vaccines and therapeutics: mRNA platform requirements and development of a scalable production process to support early phase clinical trials

Dec 6, 2021Translational research : the journal of laboratory and clinical medicine

Developing mRNA production methods to support early vaccine and treatment trials

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Abstract

A scalable aqueous-based manufacturing process for mRNA products has been developed for clinical and commercial use.

The new manufacturing process is designed to be adaptable to Good Manufacturing Practice (GMP) compliance.
Analytical methods have been established for assessing the safety, potency, and purity of the products.
Products generated through this process have shown good potency and protective effects in relevant animal models.
Challenges remain in identifying and sourcing raw materials and managing cold chain logistics for mRNA therapeutics and vaccines.
Potential solutions are suggested that align with existing regulatory guidance.

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The remarkable success of SARS CoV-2 mRNA-based vaccines and the ensuing interest in mRNA vaccines and therapeutics have highlighted the need for a scalable clinical-enabling manufacturing process to produce such products, and robust analytical methods to demonstrate safety, potency, and purity. To date, production processes have either not been disclosed or are bench-scale in nature and cannot be readily adapted to clinical and commercial scale production. To address these needs, we have advanced an aqueous-based scalable process that is readily adaptable to GMP-compliant manufacturing, and developed the required analytical methods for product characterization, quality control release, and stability testing. We also have demonstrated the products produced at manufacturing scale under such approaches display good potency and protection in relevant animal models with mRNA products encoding both vaccine immunogens and antibodies. Finally, we discuss continued challenges in raw material identification, sourcing and supply, and the cold chain requirements for mRNA therapeutic and vaccine products. While ultimate solutions have yet to be elucidated, we discuss approaches that can be taken that are aligned with regulatory guidance.

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Development of mRNA manufacturing for vaccines and therapeutics: mRNA platform requirements and development of a scalable production process to support early phase clinical trials

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