Defining The Required Critical Quality Attributes (CQAs) And Phase Requirements For mRNA/LNP Product Development And Manufacture

As mRNA therapeutics continue to evolve, developers face mounting pressure to maintain high-quality manufacturing standards under increasingly compressed timelines. Early identification of critical quality attributes (CQAs) is essential—not only to avoid delays but to ensure regulatory alignment. Yet with limited precedent and evolving global guidelines, establishing effective control strategies remains a challenge. This ebook offers a practical framework for identifying relevant CQAs to determine when they should be tested and categorizing them by control strategy type (e.g., release, stability). Each attribute is backed by industry-informed justification, which helps developers tailor quality control approaches to their specific mRNA products.

Gain clarity and actionable insight when navigating the complexities of mRNA drug product development.