Customized Roadmap: A Strategic Commercial Manufacturing Plan

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PCT_cmykThe pathway from conception to regulatory approval and commercialization of a cell therapy is long, complex, and resource intensive. To help inform numerous decisions along the way, an effective commercial manufacturing strategy for a cell therapy should be built on the four principles of what PCT calls development by design (DbD): quality, cost of goods (COGs), scalability, and sustainability. Proactively implementing a DbD strategy does not force a cell therapy developer to make a large manufacturing investment early in a project, but it does mean that the company must plan ahead. As a cell therapy moves through clinical development, working through the four facets of DbD at an early stage can provide significant cost and time advantages as well as effective management of comparability risk.

With DbD in mind, a prudent cell therapy developer will initiate and produce a strategic commercial manufacturing plan (SCMP) with the support of an experienced manufacturing partner. An SCMP provides a comprehensive, strategic, detailed roadmap to commercial deliverability. An SCMP is most appropriate for a cell therapy product developer with at least preliminary process and product definition, some first-in-man clinical testing, and a reasonable sense of commercial prospects for their candidate product.

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