Considerations In Raw Materials When Manufacturing Cell And Gene Therapies And Other Biologics

By Rebecca Warfield, Yanke Liu, Jane Liu, Spencer Chiang, ACROBiosystems

Qualifying GMP raw materials is a critical step in cell and gene therapy manufacturing, ensuring the safety, consistency, and efficacy of final therapeutics. This poster explores essential regulatory guidelines, quality control measures, and supplier qualification processes to streamline clinical manufacturing. ​From verifying material specifications to monitoring process consistency and ensuring safety, robust quality control systems are vital to eliminate contaminants and uphold product integrity. ​

Additionally, selecting reliable suppliers with certified quality management systems and ISO certifications is crucial to avoid production delays and costly revalidation studies. This poster also highlights the importance of addressing exogenous contaminants, process impurities, and residual safety risks, alongside advanced techniques like nuclease bioactivity studies and residual host cell DNA detection. ​ Early adoption of GMP principles and comprehensive documentation practices can significantly expedite regulatory approval and clinical trials. ​

Access the full content to explore detailed insights and strategies for optimizing raw material qualification in biologics manufacturing.