December 19, 2022 – ARLINGTON, VA. – The Bio-Process Systems Alliance (BPSA), the international association of the single-use bio-processing industry, is pleased to announce the election of the following BPSA Executive Board members and Directors-at-Large for 2023/2024. 

Mark Petrich, PhD, Vice President, Process Development and Validation, Krystal Biotech, Inc. has been elected BPSA Chair, 2023-2024; Joseph St. Laurent, Head of Industry Relations & Regulatory Expert, Solvias, Inc. has been elected First Vice Chair; Todd Kapp, Global Commercial Development Director-Life Sciences, Entegris, Inc., has been elected Second Vice Chair, and Hernan Parma of Renolit Healthcare and Danielle Arcuri of Qosina, Inc. have been elected to the Board as Directors-at-Large. 

“I want to congratulate Mark on being elected BPSA Chair” said BPSA outgoing Chair, Jeff Carter, PhD, of Cytiva, whose term as Chair is ending on December 31, 2022. “The BPSA Board represents the entire value chain of the single-use industry, inclusive of resin producers, component manufacturers, system integrators, global OEM suppliers, analytical laboratories and end-users, and we are pleased to have an end-user/pharmaceutical manufacturer in the role of BPSA Chair for the first time.”

“I also want to congratulate Joseph St. Laurent of Solvias, Inc. on being elected First Vice Chair, Todd Kapp of  Entegris, Inc., on being elected Second Vice Chair, and Hernan Parma of Renolit Healthcare and Danielle Arcuri of Qosina, Inc. on being elected to the Board,” Carter continued. “We thank each of our volunteer leaders for their desire to serve on the BPSA Board, and we look forward to working with them in continuing to advance the adoption and use of single-use manufacturing processes and systems in vaccine and biopharmaceutical production. We also want to thank Robert Sassa of W. L. Gore and Scott Herskovitz of Qosina, whose terms as Directors-at-Large are ending this year.” 

Mark has been active with BPSA for include over ten years, including Board and Executive Board service, first with Merck & Co., Inc., and now at Krystal Biotech, Inc. He has served as Chair of the BPSA End-User Committee, co-authored several BPSA white papers, and helped successfully launch the BPSA Sustainability Committee. 

“It’s an honor to be elected to serve as BPSA Chair for 2023-2024. I want to thank Jeff for his service to the board and his leadership as Chair,” said Petrich. “Under Jeff’s leadership, the Alliance continued to grow and to serve the needs of its members and the biopharmaceutical industry. Many of the changes and challenges presented by the COVID-19 pandemic were addressed by single-use technologies and the efforts of BPSA member companies. As demand for single-use bioprocessing systems increased, Jeff’s leadership was key to putting BPSA in a position to help our members and the patients we all serve. I look forward to working with all the BPSA members and our volunteer leaders, as well as our partners and allied organizations, to continue to advance BPSA and the single-use bioprocessing industry.”

The roster of 2023/2024 Board Members is as follows:

BPSA Executive Board Officers: 

  • Chair: Mark Petrich, Krystal Biotech, Inc.
  • First Vice-Chair: Joseph St. Laurent, Solvias, Inc. 
  • Second Vice Chair: Todd Kapp, Entegris, Inc.
  • Treasurer:  VACANT
  • Secretary: Todd Andrews, CPC
  • Scientific Advisory Board Chair, Technical Committee Chair: Kirsten Strahlendorf, Sanofi Pasteur

At-Large Directors (newly elected/re-elected) through 2024:

  • Danielle Arcuri, Qosina Corporation
  • Ralph Daumke, PendoTECH
  • Patrick Evrard, Pall Corporation
  • Charlotte Masy, GSK Vaccines
  • Ravi Narayanan, Nordson Medical
  • Hernan Parma, Renolit Healthcare
  • Mark Sitcoske, High Purity New England
  • Elisabeth Vachette, Sartorius Stedim Biotech

At-Large Directors continuing through 2023:

  • Monica Cardona, MilliporeSigma
  • Brian Chung, Solvay, Inc.
  • Dan Rosen, Thermo Fisher Scientific

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 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 Chris Clark at cclark@socma.org.

ARLINGTON, Va., Oct. 4, 2022 /PRNewswire/ — The Bio-Process Systems Alliance (BPSA), the international association of the single-use bio-processing industry, announced the election of a Secretary to its Executive Board and three at-large members to its Board of Directors for 2022-2023.

Todd Andrews, Director of Application & Business Development, Colder Products Company (CPC) will serve as Secretary, and new at-large members are:

  • Monica Cardona, Global Senior Program Manager, Single Use & Integrated Systems, MilliporeSigma
  • Brian Chung, Senior Key Account Manager – Specialty Polymers, Solvay
  • Dan Rosen, Vice President & General Manager – Single Use Technologies Flexible Solutions, Thermo Fisher Scientific

“The Alliance is pleased to have Todd Andrews join the Executive Board as Secretary,” said BPSA Chairman Jeff Carter of Cytiva. “He is very active in BPSA and has served on the Board of Directors for a number of years. I also welcome Monica Cardona, Dan Rosen and Brian Chung to the Board. I look forward to working with each of them to advance the use of single-use technologies in biopharmaceutical and vaccine production and advance the mission and objectives of BPSA.”

Todd has been involved in the single-use biopharmaceutical industry for more 15 years with a focus on single-use connection technology and has been an active BPSA member for almost 10 years. Todd has a bachelor’s degree in Plastics Engineering from University of Massachusetts, Lowell, and a master’s in business administration from the University of Saint Thomas.

Monica has been MilliporeSigma since 2019, and her previous roles include senior-level marketing and product management in the single-use and integrated systems sector. Monica served as Senior Marketing Manager-Single Use & Integrated Systems, and prior to her roles at MilliporeSigma, Monica was Global Product Manager Personal Protection Equipment with Cantel Medical Company and was Global Product Manager at Pall Life Sciences. Monica holds a bachelor’s degree in biology from Hofstra University and a master’s degree in biology from Adelphi University.

Prior to his role as Senior Account Manager at Solvay, Brian served as a Digital Sales Account Manager for Specialty Polymers and as Product Manager-Sulfation, Phosphation and Concentrates at Solvay. Brian holds a Bachelor of Science/M.S.E. in Chemical & Biomolecular Engineering from Johns Hopkins University.

Dan has been with Thermo Fisher Scientific for five years, and previously served as VP-GM for the company. Rosen has previous experience and expertise in investment banking and strategy consulting. Dan holds a bachelor’s degree from Brown University and a master’s in business administration from the Tuck School at Dartmouth College.

The complete roster of BPSA Board Members can be found here: https://bpsalliance.org/about/board-of-directors/

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 association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. Learn more at www.bpsalliance.org

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.