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CONTAINMENT & CLEANROOMS
DESIGNING VIRAL VECTOR MANUFACTURING FACILITIES FOR CGMP-COMPLIANCE Natasha Rivas, vice president of quality and regulatory, and Jose Cruz, director of vector manufacturing at Genezen, explore the difficulties in ensuring cGMP compliance is achieved throughout viral vector production. Examining best practice production suite design, they also highlight the key safety considerations needed when manufacturing these new therapeutic tools. production of these products currently involves many challenges.
A
s effective tools in facilitating vectormediated gene transfer, viral vectors – including gammaretrovirus and lentivirus – are playing an integral role in the advancement of cell and gene therapies (C&GTs). Viral vectors are commonly used in the development of chimeric antigen receptor (CAR) therapies. The growing potential of CAR therapies particularly in the oncology space - has been realised by the biopharma industry. CAR-T therapies now represent 48% of genetically modified cell therapies in the pipeline, with 98% of these in development for cancer indications. With the C&GT market predicted to grow between 2021 and 2028 at a compound annual growth rate (CAGR) of 12.4% to reach a value of $13.8 billion, reliance on viral vector development and manufacturers will rise. However, C&GTs are relatively new, meaning safe and regulatory-compliant
CGMP COMPLIANCE WITH AMBIGUOUS REGULATIONS Considering the surge in demand for C&GTs, regulations around their development and manufacturing have been relatively slow to manifest in comparison. Consequently, viral vector producers have had to shoulder the
responsibility of ensuring that their processes are safe and robust enough to remain compliant with new regulations as they arise. Conforming to ambiguous regulations written with traditional biologics in mind requires developers and manufacturers to assess how these might apply to viral vector production. Current production processes differ
significantly from those typically used for other well-established therapeutics, so it is important for viral vector developers
