The Role of Single-Use Polymeric Solutions in Enabling Cell and Gene Therapy Production, compiled by a select committee of experts in the fields of single-use technology (SUT) and cell and gene therapies.

"With more cell therapies approaching commercialisation, it is important that therapy developers have a clear understanding of both the opportunities and challenges associated with developing an entirely innovative polymer-based manufacturing process," said Brendan Lucey of ILC Dover, the BPSA Board sponsor overseeing the work product.

"Lessons from the decades of employing SUTs in monoclonal antibody production can serve the emerging CGT industry well, we believe," said Todd Kapp of Entegris, Inc., who served as committee chairman. Derek Pendlebury of CPC chaired the authoring subcommittee of 19 subject-matter experts, inclusive of a broad range of industry experts in SUTs and cell therapy research and development.

"Limitations on the wide deployment of affordable CGTs has been tied to both development costs and manufacturing costs," said BPSA Executive Director Kevin Ott. "The BPSA white paper, which was compiled over the course of 18 months, delves deeply into the needs for manufacturing innovation to help insure that affordable life-saving therapies reach patients in need."

Follow-on papers now being developed by internal BPSA Committees, to further the goal of safe CGT production, will focus on extractables, leachables and particulates. These publications are now in process, and 2019 release dates are anticipated.

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