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Cell and gene therapies are ushering in a new era of promise across a multitude of therapeutic applications, offering hope for overcoming previously insurmountable medical challenges. As a result, the sector has grown immensely, with more than 3,500 cell and gene therapies currently in development, from preclinical to pre-registration stages. Based on the current pipeline and clinical success rates of products, the FDA estimates that 10 to 20 new cell and gene therapy products will be approved annually by 2025.
While progress is certainly robust, these drugs present novel challenges and safety concerns that continue to threaten the pace of development and approval. Every stage of the complex, multi-step process of manufacturing cell and gene therapies introduces potential sources of contamination, even under carefully controlled conditions. These contaminants threaten…