Defining the required critical quality attributes (CQAs) and phase requirements for mRNA/LNP product development and manufacture

Ensuring consistent high-quality mRNA drug product manufacturing under continually compressed timelines is a significant challenge for developers. Within this environment, the early identification of critical quality attributes (CQAs) reduces the risk of product development delays and ensures alignment of product quality testing and control with regulatory agency expectations.However, mRNA is still a new modality with increasing knowledge and developing global regulatory guidelines and there is still little precedent in terms of marketed products and regulatory approvals to help guide developers through the challenges associated with manufacturing and establishing quality control strategies. This situation could adversely impact control strategies and timelines and, in turn, increase the cost of batch product

This article identifies not only relevant CQAs, but the stage at which their testing may occur and the category of control strategy (e.g. release, stability, etc.). A justification is provided for each CQA category and for each individual attribute. The justifications provide further information, based on industry experience, on whether these CQAs should be considered for products, as there are many different mRNA products, and each company will have their own in-depth understanding and specific characterization information to inform their quality control strategies

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