The emergence of advanced therapy medicinal products (ATMPs) has transformed the landscape of drug development, particularly in the realm of cell and gene therapies (CGT). While these innovative therapies offer significant potential for treating previously untreatable diseases, they also present unique challenges in manufacturing, safety, and patient administration logistics. Regulatory bodies and industry experts are increasingly recognizing the complexities involved in ATMP production, prompting updates in guidance to ensure safe manufacturing and testing practices.
Recent updates to the European Pharmacopoeia and the United States Pharmacopeia reflect this evolving landscape. The European Pharmacopoeia’s Chapter 2.6.27 and the USP’s provide critical frameworks for addressing the specific needs of short-shelf-life products. These guidelines emphasize the importance of rapid microbial testing methods, such as ATP-bioluminescence, to enhance contamination control strategies. The advancements in these methodologies not only streamline compliance but also facilitate quicker access to vital therapies for patients.
Open the full market picture for your next decision →
