Raw material testing remains a cornerstone of quality control strategies in the cell and gene therapy (CGT) sector, as recent analyses reveal persistent deficiencies in virus detection and inactivation methods. Biopharmaceutical raw materials, including culture media ingredients, reagents, and production cell lines, are identified as the primary sources of viral contamination in drug manufacturing.
To address these risks, the protein drug industry has established downstream virus detection and inactivation strategies to ensure product safety. However, CGT firms face unique challenges in achieving virus safety, as highlighted by Yoshiaki Maruyama, PhD, from Japan’s Pharmaceuticals and Medical Devices Agency. He emphasizes that viral contamination can stem from virus-laden raw materials or inadvertent manufacturing errors, necessitating stringent raw material controls and quality parameters throughout the production process.
Current viral inactivation methods often compromise the integrity of CGT products, as they were primarily designed for protein therapeutics. Maruyama notes that conventional processes can damage cells or adversely affect viral vectors, leading CGT quality control efforts to focus on raw material and product screening. Looking ahead, advancements in technologies such as next-generation sequencing (NGS) and artificial intelligence may offer innovative solutions, although further validation and development are required to ensure their efficacy in replacing traditional viral testing methods.
Open the full market picture for your next decision →
