Tuesday, March 31, 2015

BDP Week 2015: BPSA Roundtable

By: Maribel Rios, Managing Editor of BioProcess International

The Bio-Process Systems Alliance (BPSA) presented a single-use applications roundtable on Monday, 30 March 2015, at the BioPharmaceutical Development and Production (BDP) Week meeting in Huntington Beach, California. Mark Petrich, PhD (Merck & Co., Inc.) moderated the panel consisting of Jerry Martin (Pall Corporation), Jeffrey Carter, PhD (GE Healthcare), James Vogel (The BioProcess Institute), and Todd A. Kapp (Parker-Hannifin Corporation). Martin started with a historical review of the BPSA, a trade organization formed in 2005 and now consisting of 46 member companies (suppliers and end users) whose goal is to “advance single-use worldwide and facilitate implementation of single-use technologies.” 

Carter and Vogel then reviewed BPSA’s active and recent projects, consisting of the following:
·         Single-Use Manufacturing Component Quality Test Matrices (currently under final review and should be available for the BPSA Annual Summit, 13-15 July 2015, in Washington DC)
·         Change Notification Practices (currently in the initial stages of documenting)
·         Extractables (currently continuing collaboration with other organizations such as ASTM, ASME-BPE, and USP)

·         Quality Agreement Template for Single-Use Biopharmaceutial Manufacturing Products (published July 2014, currently soliciting feedback from users of the template, with possible future revisions)
·         Particulates Guide, a 12-chapter compendium addressing why particulates are an issue, how to identify them, and so on (currently soliciting further input)

The roundtable concluded with Knapp presenting the future focus of BPSA, including the annual summit and its new scholarship fund.

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