February 25, 2019
ARLINGTON, VA – The Bio-Process Systems Alliance, the primary international industry association for single-use bio-processing, is pleased to announce the release of its latest white paper, 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 commercialization, 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.
The 19-page The Role of Single-Use Polymeric Solutions in Enabling Cell and Gene Therapy Production can be downloaded now at http://bpsalliance.org/cell-and-gene-therapy-resources/.
The Bio-Process Systems Alliance (BPSA), an affiliate of SOCMA, was formed in 2005 as an industry-led corporate member association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. BPSA facilitates education, sharing of best practices, development of consensus guides and business-to-business networking opportunities among its member company employees. For more information, please visit www.bpsalliance.org.
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