Manufacturing and facility challenges facing cell and gene therapy companies are similar to but more complex than those encountered by companies that produce traditional biopharmaceuticals such as vaccines, monoclonal antibodies, and other therapeutic proteins. A single product can have multiple components, manufacturing of which may or may not be outsourced. Project timelines are short, production technologies are new and evolving, and clinical demands change rapidly. Increasing competition for contract manufacturing services requires reserving capacity far in advance, which in most cases will not offer the agility needed by developers of advanced therapy medicinal products – many of which are vying to be the first to launch a product for the same indication.

The author of this eBook explains how new technologies enabling companies to reduce their operating footprints also enable manufacturers of cell and gene therapies to bring more of their critical processes in house, constructing production facilities that can be flexible and responsive to future demands. His own company’s goal is a multimodal facility that, by incorporating a universal suite design, can produce any combination of platform products: plasmids, viral vectors, or cell therapies. Each production space should be capable of operating in any mode, with proper decontamination between campaigns, and of switching from one platform to another. The ability to leverage and customize such state-of-the-art approaches to cell and gene therapy manufacturing should hasten entry of emerging advanced therapeutics into the marketplace.

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