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Bio-Process Systems Alliance Announces the Election of Board Members (2024/2025)

ARLINGTON, VA – The Bio-Process Systems Alliance (BPSA), the international association of the single-use bio-processing industry, announced it expanded its Board of Directors to 19 members to lead the organization in 2024/2025 during its recent election.

Kirsten Strahlendorf, M.Eng., P.Eng., PMP, Senior Unit Head, BioProcess Engineering Unit, Sanofi, has been elected Second Vice Chair; Todd Andrews, Director Application and Business Development, Biopharma, CPC, has been re-elected Secretary, and Ravi Narayanan, Global Product Management Leadership-Biopharma & Medical Device, Nordson Medical has been re-elected Treasurer. Also, Chris Wilkins, PhD, Vice President, Strategic Marketing, Filtration Group; Jayanthi Grebin, Business Development Manager Pharmaceuticals NA, Freudenberg Medical; Thomas Vandromme, Business Development Director, Meissner; Monica Cardona, Global Senior Marketing Manager Single Use Systems, Millipore Sigma; Dianne Heiler, Global Head of Packaging Engineering and Sustainability, Repligen Corporation; Brian Chung, Senior Key Account Manager, Specialty Polymers, Solvay and John Puglia, PhD, Senior Director, Global R&D, Thermo Fisher Scientific were elected as Directors-at-Large.

“Congratulations to Kirsten, Todd and Ravi on being elected to the BPSA Executive Board and congratulations to our new and returning BPSA Board members,” said Mark Petrich of Krystal Biotech, BPSA Chair. “I want to thank each of our dedicated volunteer leaders who have chosen to contribute their time and expertise to the BPSA Board. I look forward to working together to advance the mission of BPSA. I would like to express my appreciation to Dan Rosen, Vice President & General Manager, Thermo Fisher Scientific and Scott Patterson, Vice President Pharma & Biotech Technical Support, ILC Dover, whose terms as Directors-at-Large are ending this year.”

BPSA Executive Board Officers:

  • Chair: Mark Petrich, PhD, Krystal Biotech
  • 1st Vice Chair: Todd Kapp, Entegris, Inc.
  • 2nd Vice Chair: Kirsten Strahlendorf, Sanofi
  • Secretary: Todd Andrews, CPC
  • Treasurer: Ravi Narayanan, Nordson Medical

At-Large Directors (newly elected) through 2025:

  • Chris Wilkins, PhD, Filtration Group
  • Jayanthi Grebin, Freudenberg Medical
  • Thomas Vandromme, Meissner
  • Dianne Heiler, Repligen Corporation
  • John Puglia, PhD, Thermo Fisher Scientific  

At-Large Directors continuing through 2024/2025:

  • Patrick Evrard, Cytiva
  • Charlotte Masy, GSK
  • Mark Sitcoske, High Purity New England
  • Monica Cardona, Millipore Sigma
  • Ralph Daumke, PendoTECH
  • Danielle Arcuri, Qosina Corporation
  • Hernán Parma, RENOLIT Healthcare
  • Elisabeth Vachette, Sartorius
  • Brian Chung, Solvay

Board members are elected by the general membership and serve staggered two-year terms. The Board determines the governing policies of BPSA, establishes the budget and priorities, and directs the organization’s goals and priority areas of focus.

Please visit https://bpsalliance.org/about/board-of-directors/ for a complete list of BPSA Board of Directors.

The Bio-Process Systems Alliance (BPSA), is 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, best practice sharing, development of consensus guides and networking opportunities among its member companies. For more information, visit www.bpsalliance.org, or contact Executive Director Chris Clark at cclark@socma.org.

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Bio-Process Systems Alliance Releases the 2023 Single-Use Manufacturing Component Quality Test Matrices

Arlington, VA – The Bio-Process Systems Alliance (BPSA), the international trade association of the single-use bio-processing industry, announced the release of the 2023 Single-Use Manufacturing Component Quality Test Matrices (QTM).

Originally developed in 2007, the BPSA QTM is designed as a technical guide to help facilitate the validation and qualification of single-use products. The latest third edition was necessitated by the rise in the number of components, the expansion of test practices, and the introduction of new standards.

The guide includes six comprehensive test categories—physical, functional, biological, chemical, regulatory, and sterilization/sanitization—commonly associated with single-use components. Additionally, it covers seven individual single-use component categories, including chromatography, connectors, valves and retainers, containers and film, sensors, tubing, filters, and single-use assemblies. The guide provides links to public domain test methods or source locations, detailed descriptions of how each test is applied (e.g., in material qualification, product qualification, and lot release), and a comprehensive list of terms and definitions in a dedicated reference section.

The 2023 QTM technical guide was developed by a volunteer committee of BPSA members, with leadership from the BioProcess Institute (North Kingstown, RI). “The BPSA QTM is a very important tool for single-use suppliers and end-users alike, and this update will help advance the single-use bioprocessing industry,” said Kirsten Strahlendorf of Sanofi, and Chair of the BPSA Scientific Advisory Board.

The updated QTM technical guide also accounts for changes to common practices by single-use component and assembly providers as well as sterilization process compatibility, pre-use treatment, as well as sterilization (irradiation and thermal) exposure to test samples.

The 2023 BPSA QTM technical guide is now available for download at https://bpsalliance.org/resources/technical-guides/ . For additional information, please contact BPSA Executive Director Chris Clark at cclarck@socma.org.

The Bio-Process Systems Alliance (BPSA), 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. BPSA facilitates education, sharing of best practices, development of consensus guides and business-to-business networking opportunities among its member company employees.  www.bpsalliance.org.

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Bio-Process Systems Alliance Responds to European Chemicals Agency’s Proposed Universal Ban on PFAS

Arlington, VA – The Bio-Process Systems Alliance (BPSA) has submitted comments in response to the European Chemical Agency’s (ECHA) proposed ban on per- and poly-fluoroalkyl substances (PFAS).

In February, ECHA announced its proposed restriction on PFASs, a unique family of nearly 10,000 substances, including fluoropolymers, under the European Union’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation which addresses the production and use of certain chemical substances, and their potential impacts on human health and the environment. PFAS are used extensively across multiple industries, including bioprocessing, due to their unique functional properties and low reactivity.

This restriction proposes a universal ban over time on the use of all fluoropolymers in all applications, without distinguishing between fluoropolymers and other PFAS substances. Fluoropolymers, including PTFE and PVDF, are some of the most common PFAS types understood to be used in the bioprocess industry, considered as polymers of low concern by the Organisation for Economic Co-operation and Development, and deemed to have insignificant environmental and human health impacts. In its response to ECHA, BPSA requested that pharmaceutical and biopharmaceutical processing, including its supporting supply chain, be regarded as a sector, and permitted the same exemption, or unlimited derogation, as medicinal products.

“BPSA maintains a commitment to sustainability and fully supports efforts to minimize and mitigate the presence of substances which pose a threat to human health and the environment. However, the proposed broad restriction of PFAS covering fluoropolymers would have unintended consequences on the global manufacturing of biopharmaceutical products ultimately impacting availability of existing medicinal therapies, including vaccines, as well as the development of new therapies,” said BPSA Executive Director, Chris Clark. “Let’s find solutions that better balance the environmental and health concerns with the needs of patients, consumers and the bioprocessing industry.”

BPSA is committed to working collaboratively to ensure any proposed restrictions consider the unique challenges of the bioprocessing industry and the needs of patients and consumers. We urge ECHA to reconsider its proposed restriction based on the available scientific data and risk assessments regarding PFAS substances, including fluoropolymers, used in bioprocessing.

BPSA also supports the positions of the European Federation of Pharmaceutical Industries and Associations, BioPhorum, the European Sealing Association, the American Chemistry Council, and the American Society of Mechanical Engineers – Biopharmaceutical Process Equipment sector.

The Bio-Process Systems Alliance (BPSA) 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.

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BPSA Releases Volume 2 of Its Technical Guide for the Design, Control, and Monitoring of Single-Use Systems (SUS) for Integrity Assurance

ARLINGTON, VA – The Bio-Process Systems Alliance (BPSA) announced the release of its latest guide, Design, Control & Monitoring of SUS for Integrity Assurance: Volume 2, which serves to follow up to BPSA’s 2017 guide, Design, Control & Monitoring of SUS for Integrity Assurance.

The increasing use of single-use technologies (SUTs) in bioprocessing has made integrity assurance a critical quality attribute for both suppliers and end-users of SUTs. In 2017, the BPSA published the Design, Control, and Monitoring of Single-Use Systems for Integrity Assurance that provided recommendations to both suppliers and end-users in the single-use technology industry regarding strategies, tools and procedures that can assist in providing enhanced assurance of integrity of single-use systems.

This 49-page guide (Volume 2) provides case studies illustrating the principles developed in Volume 1; updates to key technologies used by the industry; updates to the regulatory landscape and industry guidance, and case studies covering specific applications such as elevated pressure situations and containment of powders. The guide also addresses essential concepts such as Quality by Design (QbD) and fostering collaboration between suppliers and end-users.

“The bioprocessing industry has made tremendous progress on leak and integrity testing of SUS over the past few years, and the examples and case studies included in this guide illustrate the progress the single-use industry has made,” said Patrick Evrard of Cytiva, and Chair of the BPSA Integrity Assurance Committee.

“I want to thank the BPSA Integrity Assurance Committee, and its Chair, Patrick Evrard of Cytiva, for their leadership and hard work on this guide,” said BPSA Executive Director, Chris Clark. “This guide is an important tool for suppliers and end-users alike and supports our mission of driving the adoption of SUS worldwide.”

Please visit  https://bpsalliance.org/technical-guides to download the guide.

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.

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BPSA Releases Guide on X-Ray Sterilization of Single-Use Bioprocessing Equipment, Part 2: Representative Qualification Data

July 12, 2023 – Arlington, VA – The Bio-Process Systems Alliance (BPSA) announces the release of its latest guide, “X-Ray Sterilization of Single-Use Bioprocessing Equipment, Part 2: Representative Qualification Data”, which serves to follow up on BPSA’s 2021 white paper, “X-Ray Sterilization of Single-Use Bioprocess Equipment, Part 1: Industry Need, Requirements & Risk Evaluation.”

Supply challenges and availability of gamma irradiation for sterilization have continued to increase, leading many single-use component and system suppliers to implement X-ray irradiation as an alternative to gamma irradiation. To support the risk assessments needed for such implementation, BPSA has generated supporting data evaluating the performance levels of X-ray sterilization and gamma-ray sterilization on certain single-use materials.

“There is a lot of concern about whether gamma contract irradiation capacity will be sufficient to meet the increasing demand from the bioprocessing industry,” said James Hathcock of Cytiva, Co-Chair of the BPSA X-ray Committee. “This research and accompanying white paper is a critical initiative for BPSA and the entire single-use industry.”

The resulting data in the new BPSA guide demonstrates the equivalent impact of X-ray irradiation of single-use materials as gamma. It also includes examples of data comparing X-ray and gamma irradiated components, generated by multiple component manufacturers for different types of single-use components and materials. “We are very pleased the examples verify the science-based understanding that X-ray and gamma impacts on single-use systems are equivalent,” said Samuel Dorey of Sartorius, BPSA X-ray Committee Co-Chair.

“I want to thank the BPSA X-ray Committee and its Co-Chairs, James Hathcock of Cytiva and Samuel Dorey of Sartorius, for their leadership of this initiative,” said BPSA Chair Mark Petrich, PhD, Krystal Biotech. “The results presented in this white paper are very good news, not only for single-use suppliers, but for customers and patients around the world who rely on our products. Advancing X-ray as a mode of sterilization is critical, for BPSA members and the broader bioprocessing industry.”

The 63-page guide results from a multi-year project, produced by BPSA members, industry stakeholders and subject-matter experts. The project team met with FDA’s Center for Drug Evaluation & Research Emerging Technologies Team, the European Medicines Agency Quality Innovation Group, and the Japan Pharmaceuticals and Medical Devices Agency to advance the adoption of X-ray technology for sterilization.

Please contact BPSA Executive Director, Chris Clark, at cclark@socma.org, and/or visit the BPSA website to download a copy of the white paper.

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.

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Bio-Process Systems Alliance Announces Election of Treasurer, New At-Large Director

May 2, 2023 – ARLINGTON, VA – The Bio-Process Systems Alliance (BPSA), the international association of the single-use bio-processing industry, announced the election of a Treasurer to its Executive Board and one Director-At-Large to its Board of Directors. Mr. Ravi Narayanan, Global Product & Market Management, Nordson Medical (Ft. Collins, CO) has been elected as BPSA Treasurer, succeeding Mr. Eric Isberg, who vacated the role last year. In addition, Mr. Scott Patterson, Vice President, PharmBio Technical Support, ILC Dover (Frederica DE) has been elected as Director-At-Large.

“The Alliance is pleased to welcome Ravi to the Executive Board as Treasurer and to welcome Scott to the Board as Director-At-Large,” said BPSA Chairman Mark Petrich of Krystal Biotech. “Ravi has been very active in BPSA and has served on the Board of Directors since 2022. Scott has been an active contributor and has been involved in BPSA activities for a number of years. I look forward to working with each of them to advance the use of single-use technologies in biopharmaceutical and vaccine production and to promote the mission and objectives of BPSA.”

Ravi Narayanan has over twenty-five years of leadership experience in product management and strategic marketing, new product development, and program management in the biopharmaceutical and medical industries. Ravi joined the BPSA Board in 2022 and has served in leadership positions in several other industry organizations affiliated with medical and biopharma devices, and disposables.

Scott Patterson has been active in a range of processing technologies for over 40 years with the past 25 years emphasizing pharmaceutical and biopharmaceutical processing. As a Vice President and Technical Leader with ILC Dover, Scott has focused on the use of single-use systems applied for high containment when handling potent compounds or solving large molecule upstream processing challenges. Scott has participated in multiple industry advocacy organizations including two BPSA committees.

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