Upstream processing of viral vectors: a summary

Cell and gene therapies (CGT) represent a revolutionary approach to treating a wide range of diseases. However, their complex nature presents unique challenges upstream, during the manufacturing process, and downstream, in regulatory approval. This article explores the role of upstream processing, specifically the application of upstream process parameters of CGT, process analytical technologies (PAT), in optimizing CGT manufacturing. Upstream considerations include sourcing and expanding starting materials, like stem cells or viral vectors, while ensuring scalability and adherence to good manufacturing practices (GMPs). Challenges in differentiation and process control are also addressed. Furthermore, the regulatory frameworks are crucial for patient safety and product efficacy. The abstract discusses key regulations, such as those outlined by the US FDA, and the evolving landscape as the field progresses. International regulatory differences and their impact on global distribution are also explored. By understanding both upstream complexities and the evolving regulatory environment, developers can navigate the path to bringing safe and effective CGT products to patients. In conclusion, the abstract will emphasize the potential of PAT to revolutionize upstream processing in CGT manufacturing. By fostering a deeper understanding of the relationship between process parameters and product quality, PAT can pave the way for robust and efficient production of life-saving cell and gene therapies.

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