Analytical control strategies for DNA starting materials in rAAV gene therapies and mRNA vaccines

The importance of ensuring high-quality DNA starting materials has become increasingly significant due to advancements in gene therapies and mRNA products. In this paper, we explore the critical elements of a plasmid DNA (pDNA) control strategy, focusing on analytical quality and process-related impurities. Additionally, we examine the challenges and considerations in adapting these strategies to synthetic DNA starting materials. Establishing effective control measures early in the production stages is crucial for guaranteeing the final product’s quality, safety, and efficacy. By presenting a comprehensive framework for DNA starting material control strategy, this paper aims to support the development of robust and reliable DNA manufacturing processes and testing strategies.

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