Bio-Process Systems Alliance Releases 2020 Extractables/Leachables Guide

ARLINGTON, Va., Sept. 17, 2020 /PRNewswire/ -- The Bio-Process Systems Alliance (BPSA), the international association of the single-use bio-processing industry, is pleased to announce the release of its latest 2020 technical guide: Extractables/Leachables Considerations for Cell & Gene Therapy Drug Product Development.

The guide is a direct adjunct to the 2019 BPSA Guide: The Role of Single-Use Polymeric Solutions in Enabling Cell and Gene Therapy Production, and reflects industry’s ongoing progress in driving steady improvements to the cleanliness, safety and performance of polymer-based single-use bio-processing systems.

Known as the “2020 BPSA CGT Extractables Guide,” the 17-page/nine-part compendium was derived from a recognized need in the single-use technology (SUT) industry to address CGT extractables issues inclusive of the fact that:

• Cell therapies have the potential to treat various disease states, including cancer, liver disease and primary immuno-deficiency disorders;
• Leachable chemical entities in CGT automated or manual processes can originate from single-use systems and must be assessed and controlled;
• As part of the responsibility of producing a drug product or device submission, a drug sponsor is required to prepare and submit a thorough and appropriate E/L study;
• Current regulatory schemes – Food & Drug Administration (FDA) and U.S. Pharmacopeia (USP) – provide general guidance and are detailed in the guide;
• Regulatory requirements will increase, and study sponsors will need to demonstrate that their E/L study design will satisfy regulators.

The guide provides perspectives on topics important to patient outcomes as cell and gene therapy products evolve into mainstream therapeutic options for those patients.

The full-color, illustrated guide includes a comprehensive set of terms and definitions, and a complete reference section.

The 2020 BPSA CGT Extractables Guide is an 11-month project funded and executed with input and guidance from a volunteer committee of subject-matter experts representing the following BPSA member companies: Millipore Sigma, VR Analytical, Smithers MDT, Colder Product Company (CPC), Solvay, Entegris, Gemini Bio, American Renolit and Chemic Laboratories.

Download the Guide at www.bpsalliance.org.

For more information, e-mail BPSA Executive Director Kevin Ott at kott@socma.org.

About BPSA
The Bio-Process Systems Alliance (BPSA), an affiliate of SOCMA, was formed in 2005 as an industry-led international association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals, cell and gene therapies and vaccines. www.bpsalliance.org.

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SOURCE Bio-Process Systems Alliance (BPSA)