Arlington, VA – The Bio-Process Systems Alliance (BPSA) announced the publication of its latest guide, the 19-page Single-Use Technologies Enable Manufacturers to Meet Pivotal Challenges of Viral Vector Manufacturing.

Recent years have seen dramatic breakthroughs in cell and gene therapies. Cell and gene therapy (CGT) is a science that is ushering in a new era in medicine. One of the main focuses of this technique is the optimization and delivery of Viral Vector vehicles that are mostly nanostructures, or viruses.

This new BPSA guide discusses present and future challenges in gene therapy manufacturing and how single-use technologies (SUTs) can improve the manufacturing process, including upstream production and downstream purification; product and operator safety; processing in closed systems and how single-use technology enables cost-effective manufacturing. The white paper also sheds light on some of the future opportunities for SUTs in gene therapy production.

“SUT’s are essential to viral vector manufacturing success, and this guide provides insights that will enable biopharmaceutical manufacturers to make smart choices about where single use can improve outcomes and speed of therapies to market,” said Brendan Lucey, Global Director of Cross Business Unit Market Strategy, Entegris, and Chair of the BPSA Cell and Gene Therapy Committee.

Viral Vector manufacturing is still in an early stage of development, and this emerging segment in biopharmaceutical manufacturing is benefiting from the recent surge in production of vaccines and monoclonal antibodies in response to the Covid-19 pandemic. While challenges still exist in the scale-up of Viral Vector manufacturing components, SUTs have been almost fully integrated in the process at commercial scale, and the SUT supply base is actively responding to these needs.

“The Viral Vector white paper is the culmination of an 18-month process, and I want to thank the BPSA Cell and Gene Therapy Committee, and all of the authors, contributors and editors for their hard work on this guide,” said Chris Clark, BPSA Executive Director. “BPSA and the single-use supply chain continues to work collaboratively to ensure a robust, safe, and reliable manufacturing base for cell and gene therapy production.”

Contact BPSA Executive Director, Chris Clark, to learn more, or visit the BPSA website to download a copy.


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

June 14, 2022 – Arlington, VA.–The Bio-Process Systems Alliance (BPSA), an affiliate of the Society of Chemical Manufacturers & Affiliates (SOCMA), announced it has named Christopher Clark, CAE, as its new Executive Director, effective June 1. Clark succeeds Kevin Ott, who served as BPSA Executive Director from 2007-2022.

“I want to congratulate and thank Kevin Ott for his 15 years of leadership and dedication to BPSA as Executive Director. Kevin has been with BPSA since the Alliance’s formation, and the organization would not be where it is today without his strategic guidance,” said BPSA Board Chair Jeff Carter, PhD, Consumables Product Strategy Leader, Cytiva.

Clark has spent more than 16 years in senior roles with national trade associations. As Executive Director, Clark will assume all day-to-day responsibilities of BPSA and work closely with the board of directors, membership, and affiliate partner the Society of Chemical Manufacturers & Affiliates (SOCMA), to ensure continued growth of the organization.

“The leadership and accomplishments Chris brings in association management make him an ideal choice for BPSA’s new Executive Director,” said Carter. “He brings significant leadership experience advocating for members and developing association programs and I look forward to working with him as we begin
the next chapter of our organization.”

Clark joins BPSA most recently from the North American Millers’ Association, where he served as Vice President, Communications & Administration. Prior to that, he was Vice President of Operations at the American Bakers’ Association, and Vice President of Operations, Member Service & Education at the
Snack Food Association (SNAC International). Clark is a Certified Association Executive (CAE) and member of the American Society of Association Executives.

“I am honored to join BPSA as its new Executive Director,” said Clark. “Single-Use Technologies are transforming how bio-pharmaceutical companies produce and deliver vaccines and other vital products, and I look forward to working with the BPSA membership and staff to advance the single-use
biopharmaceutical manufacturing industry,” said Clark.

About BPSA
Formed in 2005, the Bio-Process Systems Alliance (BPSA) is an industry-led international industry association of nearly 70 member companies dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. BPSA’s mission is to facilitate, globally, the development and manufacturing of biopharmaceuticals through the implementation of robust, safe and sustainable Single-Use Technologies.
www.bpsalliance.org

Contact
Chris Clark cclark@socma.org 571-348-5109

ARLINGTON, Va., Nov. 2, 2021 /PRNewswire/ — The Bio-Process Systems Alliance (BPSA), the international industry association of the single-use bio-processing industry, is pleased to announce the election of Board of Directors members who will serve two-year terms in leadership roles through December 31, 2023.

“With this election cycle we’re pleased to welcome back three members of our leadership team for new terms, as well as two re-elected at-large Directors, and two new Directors,” said Kevin Ott, BPSA Executive Director.

“As a unified Board, they represent a highly diverse leadership team that continues to work on issues of importance to the entire value chain of the single-use bio-processing industry, including resin suppliers, component manufacturers, systems integrators, auxiliary service and equipment suppliers and users,” Ott said. “This diversity is the historic strength of BPSA, and that tradition continues with our 2022/2023 slate of Board members.”

Executive Board officers for 2022-2023 are:

  • BPSA Treasurer: Eric Isberg, Savillex
  • Corporate Secretary: Janmeet Anant, Millipore Sigma
  • Scientific Advisory Board Chair: Kirsten Strahlendorf, Sanofi Pasteur Board of Directors members for 2022-2023 are:
  • Mukta Acharya, Thermo Fisher Scientific
  • Anna Maria Bertasa, Solvay Specialty Polymers
  • Todd Kapp, Entegris, Inc.
  • David Radspinner, ILC Dover

Continuing roles on the Executive Board through 2022 are:

  • Chair: Jeff Carter, Cytiva
  • First Vice-Chair: Mark Petrich, Krystal Biotech
  • Second Vice-Chair: Joseph St. Laurent, Chemic Laboratories, Inc.

Board of Directors members continuing through 2022 are:

  • Todd Andrews, CPC
  • Ralph Daumke, FILTROX AG
  • Patrick Evrard, Pall Corporation
  • Scott Herskovitz, Qosina Corporation
  • Charlotte Masy, GSK Vaccines
  • Ravi Narayanan, Nordson Medical
  • Robert Sassa, W.L. Gore & Associates
  • Mark Sitcoske, High Purity New England
  • Elisabeth Vachette, Sartorius Stedim Biotech

Both the Board and Executive Board hold bi-monthly virtual meetings. BPSA currently has 68 corporate members and is the primary trade association for the single-use industry. Headquartered in Washington, DC, BPSA has represented the full value-chain of single-use interests since 2005.

About BPSA

The Bio-Process Systems Alliance (BPSA), an affiliated organization of the Society of Chemical Manufacturers & Affiliates (SOCMA), was formed in 2005 as an industry-led corporate member industry 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, visit www.bpsalliance.org, or contact Executive Director Kevin Ott at kott@socma.org.

CONTACT: Kevin Ott, Executive Director, BPSA, (571) 348-5104, kott@socma.org

Guide defines roles and responsibilities of suppliers and users of polymeric single-use systems

ARLINGTON, Va., Feb. 18, 2021 /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 2021 technical guide: Transit Testing Guidance for Single-Use Components and Assemblies.

The safety and performance of single-use bioprocess polymeric equipment, employed to manufacture biologic therapies and vaccines, is based on sterility and integrity and other stringent validation controls.

Delivery of single-use (SU) products requires that equipment be handled both mechanically and manually throughout the entire supply chain, from the point of manufacture to the point of use. In this vein, understanding supply chain hazards related to human error, shock, vibration, heat, compression and atmosphere will help determine the need and approach for in-depth, risk-based transit testing.

As detailed in the guide, a risk assessment may be based on the process step, the type of distribution cycle, historical data, or the nature/scope of a packaging change or new design being implemented. The guide will assist the reader in determining the proper approach, or need for, transit safety testing either in a field or laboratory setting.

The full-color, illustrated guide includes a comprehensive set of terms and definitions, and appendices inclusive of ASTM, FDA, PDA, ISTA, EMA and ISO references, among others.

The 28-page illustrated guidance document represents an 18-month project, funded by BPSA, and produced by a wealth of subject-matter experts in the areas of transportation, packaging, quality assurance, vaccine and biologic production and physical product testing.

The writing team was led by Smithers. Additional authors are subject matter experts (SMEs) from Sartorius- Stedim Biotech, Entegris, Inc., Repligen Corporation, CPC, Pall Medistad BV, Sanofi Pasteur Ltd, and the Michigan State University School of Packaging. The guide is available for complimentary download at www.bpsalliance.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.

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