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Fall 2014
In This Issue:
BPSA BOARD OF DIRECTORS ELECTION RESULTS ANNOUNCED | BPSA
RELEASES PARTICULATES GUIDE and QUALITY AGREEMENT
TEMPLATE FOR SINGLE-USE PRODUCTS | BPSA HOSTS SUCCESSFUL 2014
SUMMIT AND ANNOUNCES 2015 AND 2016 SUMMIT DATES | BPSA DEBUTS
THEIR MEMBERS ONLY WEBSITE PAGE | 2015 BPSA MEMBERSHIP DUES
INVOICES SCHEDULED TO BE SENT MID-NOVEMBER WITH NO RATE
INCREASE | BPSA WELCOMES NEW MEMBERS |
A NOTE FROM THE EXECUTIVE DIRECTOR
BPSA Announces Results of the Board of Directors 2015-2016 Term Elections
BPSA Board Election votes have been tallied, and BPSA is pleased to announce the results. Elected to
the BPSA Executive Board as Officers for the 2015-2016 term are:
Chair: John Boehm, CPC
First Vice Chair: Jeffrey Carter, GE Healthcare Life Sciences
Second Vice Chair: Mark A. Petrich, Merck & Co., Inc.
Along with the above-listed officers, the BPSA Board of Directors members elected to serve for the term
of 2015-2016 are:
Kenneth R. Davis, Value Plastics, Inc. /Nordson Medical
Patrick Evrard, GSK Vaccines
Bill Hartzel, Catalent Pharma Solutions
Helene Pora, Pall Corporation Single-Use Technologies
Paul Priebe, Sartorius Stedim Biotech
Joseph St. Laurent, Chemic Laboratories, Inc.
Continuing in their roles on the Executive Board through 2015 are, as BPSA Treasurer and BPSA
Secretary respectively, Kenneth L. Bibbo (Jacobs Engineering), and Todd E. Kapp (Parker-Hannifin
Corporation).
The BPSA Board of Directors members continuing through 2015 are:
Ken Baker, AdvantaPure/NewAge Industries
Roman Rodriguez, EMD Millipore
Cory Stevenson, Thermo Fisher Scientific
Kirsten Strahlendorf, Sanofi Pasteur
© 2014 The Bio-Process Systems Alliance. All rights reserved. | www.bpsalliance.org
The Board elections were held in early October as dictated by the By-Laws that govern the Alliance.
Each BPSA Voting Member representatives had the opportunity to select and vote for candidates to
serve on the BPSA Board. The BPSA Board of Directors is responsible for the agenda, technical projects,
budgets, and By-Laws that govern the Alliance, as well as its overall strategic approach and work plan.
Consider submitting your name in August 2015 for the next round of Board elections!
BPSA Releases Particulates Guide
BPSA unveiled its new technical guide, Recommendations for Testing, Evaluation, and Control of
Particulates from Single-Use Processing Equipment, during their Annual Membership meeting in July in
Washington, DC. Known as the “BPSA 2014 Particulates Guide,” the 12-chapter compendium was
derived from a recognized need in the single-use technology (SUT) industry to address why particulates
are an issue with SUT, how to control particulates and what steps to take when particulates are found
and attributed to SUT. The document is intended for both SUT users and component and systems
suppliers of single-use equipment. The guide also covers terms and definitions and is inclusive of a
complete reference section.
The BPSA 2014 Particulates Guide was a dedicated 18-month project funded and executed by BPSA
under the guidance of a volunteer member committee of subject-matter experts representing the
following companies: Value Plastics, Inc., GSK Vaccines, Pall Life Sciences, EMD Millipore, Entegris, Dow
Corning Corporation, Merck & Co., Inc., AdvantaPure/New Age Industries, Sanofi Pasteur, and The
BioProcess Institute.
The Particulates Guide is free to all BPSA members and can be accessed via the Members Log In tab of
BPSA’s website, www.bpsalliance.org. For password information, please contact
[email protected]. The Guide is available to non-members for a fee of $295. The order form can
be found at www.bpsalliance.org.
New: Consensus Quality Agreement Template for Single-Use Products
BPSA’s Consensus Quality Agreement Template for Single-Use Biopharmaceutical Manufacturing
Products (QAT) was released in July at BPSA’s Annual Membership Meeting held in Washington, DC. The
QAT addresses the need for a “common structure” for quality agreements between single-use suppliers
and users. The template provides structure to the dialog between users and customers that
immediately focuses on common ground, thus streamlining the negotiation process. The 19-page
guidance document is the result of a two-year effort led by an internal committee of BPSA members.
Quality experts from GE Healthcare, EMD Millipore, CPC, Value Plastics, Sartorius-Stedim Biotech, BIA
Separations, AdvantaPure/NewAge Industries, GSK Vaccines, Pall Corporation, Merck and Co., Inc., and
Sanofi Pasteur all assisted in bringing this project to fruition.
The guide is available for free download and distribution at www.bpsalliance.org.
BPSA’s 2014 Summit Declared a Huge Success
BPSA hosted its fourth annual International Single-Use Summit July 9-11, 2014 at the Four Seasons hotel
in Washington, DC. Summit attendees declared the Summit to be a “very impressive meeting, which will
definitely positively influence our future business” and “the best meeting of any other out there.
Networking is at its peak through the entire session.” Beyond the “topical experts” presenting as part of
the Summit’s structured program, this year’s agenda took advantage of its well-informed attendees,
already fully-versed on SUT implementation and technical issues, by presenting in-depth, interactive
panels on the Single-Use Supply Chain, the Future of a Consensus-Based Extractables Standard and
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Particulates. The chance to share knowledge and express opinions with the assembled audience, on and
off the podium, is inherent to the Summit - THE premier meeting focused on the business of SUTs.
MARK YOUR CALENDARS NOW FOR THE 2015 AND 2016 BPSA International Single-Use Summit: July
13-15, 2015, and July 11-13, 2016, at the Four Seasons Hotel in Washington, DC.
To gain access to the 2014 Summit presentations, or to participate on the 2015 Summit Program
Committee, contact Jeanette McCool at [email protected].
BPSA DEBUTS MEMBERS ONLY PAGE
As mentioned above, BPSA recently added a Members Only Log In tab to their website,
www.bpsalliance.org. Currently, the 2014 Particulates Paper, 2014 Quality Agreement Template and
the 2010 Extractables Guide can be accessed on this page. Member access is via password - please
contact [email protected] for password information.
Your 2015 BPSA Members Dues Invoice
BPSA will issue 2015 member dues invoices on November 15, 2015. Dues rates will remain at the 2014
levels, due in large part to the Summit’s success and our generous sponsors. Please consider a yearly
sponsorship commitment to BPSA in addition to your dues. Elite sponsorships support BPSA events,
sustain BPSA’s advocacy of single-use manufacturing technologies, and reinforces your company’s
position as a leader in the Single-Use Technology arena. Sponsorship packages can be found on BPSA’s
home page, or contact Jeanette McCool, [email protected] for more information.
Please make sure to add [email protected], [email protected] and [email protected] to your email
Safe-Senders List.
BPSA Welcomes New Members
We are very pleased to welcome the following companies to the BPSA family of members:
Entegris, RMD Products, Smithers Rapra and Zenpure, Inc.
A Note from the Executive Director
A close reader of the make-up of our “new” Board (see our lead story) will notice two things: the BPSA
Board is becoming decidedly more international; and, the Board is now comprised of four “End-Users”
representing biopharma, as well as the head of a respected analytical laboratory. Strategically, this is a
huge development. As single-use moves into the manufacturing and fill-finish steps in the drug
manufacturing process, the challenges single-use systems suppliers face in “mitigating risk” move to
center stage. This is why efforts to define a uniform extractables standard, a focus on change-order
management, and a close scrutiny of integrity testing - not to mention particulates and GMP - will
continue to dominate the BPSA technical landscape for years to come. The bright side here is that
integrating user and supplier expertise in our Board leadership, now inclusive of North America and the
EU, as well as a diverse set of business interests, allows BPSA to truly function as the “Single Voice for
Single-Use.” Our maturing relationship with the UK-based BioPhorum Operations Group (BPOG), the
regular inquiries we receive from Asia to purchase technical guides or learn more about BPSA, and our
relationships with ASTM, ASME/BPE and PDA are absolutely encouraging, and signal further growth and
opportunity for BPSA and its allied members.
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Our Board will meet at least eight times next year (in person and via teleconference) to address
pertinent technical and business issues. The proximity of expert opinions around our conference table
will undoubtedly spell success and relevance for the rapidly-growing Alliance as we move into the next
five-year phase of business adoption and acceptance of single-use. To those members not represented
(yet) on our Board, that door opens again in the Fall of 2015. And, to all of our members, we always
appreciate your suggestions, comments and critiques of our efforts to Advance the Adoption of SingleUse Worldwide. Thank you for your support! . . . Kevin Ott, BPSA Executive Director, [email protected].
2014 BPSA Elite Sponsors
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About BPSA
The Bio-Process Systems Alliance (BPSA) was formed in 2005 as an industry-led corporate member trade
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 about BPSA, visit www.bpsalliance.org or contact BPSA Executive Director Kevin
Ott at 202-721-4125.More available at www.bpsalliance.org. Contacts: [email protected], or
[email protected].
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