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BPSA releases guide to production of cell and gene therapies

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Posted: 25 February 2019 | | No comments yet

The Bio-Process Systems Alliance, the primary international industry association for single-use bio-processing, is pleased to announce the release of its latest whitepaper…

BPSA

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.

 

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This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.

Access the full report now to discover the techniques, tools and innovations that are transforming pharmaceutical formulation, and learn how to position your organisation for long-term success.

What you’ll discover:

  • Key trends shaping the pharmaceutical formulation sector
  • Innovations leading progress in pharmaceutical formulation and how senior professionals can harness their benefits
  • Considerations and best practices when utilising QbD during formulation of oral solid dosage forms
  • And more!

Don’t miss your chance to access this exclusive report ! Access now – it’s free

“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.

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/.

To find out more about BPSA, please click here

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