Cell and gene therapy commercial off-the-shelf software components

This article aims to provide readers with an understanding of how the use of commercial off-the-shelf software (COTS) makes cGMP cell and gene therapy manufacturing easier, safer, reliable, scalable, compliant, and cost-effective from early research and development (R&D) through commercial production. Several biotech and pharma COTS products that support GxP manufacturing and list common functionalities will be described. This is by no means an exhaustive list of available products. This article will provide a high level of understanding of the COTS landscape and the need for good research and planning, as well as the importance of taking an interdisciplinary approach in cGMP cell and gene therapy manufacturing. As can be seen from the variety of expertise and skills required throughout the manufacturing process, we cannot operate safely and efficiently in siloed teams as we work through the initial developmental biology, then materials engineering, and finally cell and gene therapy manufacturing.

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