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.

Single-use technology (SUT) has had a major impact on how precision biologic therapies are manufactured. So, what does the future hold for SUT in a world where single-use plastics are increasingly seen as an “eco-threat” instead of a means to manufacture life-saving therapies? Kevin Ott explains why sustainability is a complicated concept, but one that must be addressed by the single-use industry as we move into the next decade of SUT adoption and growth.

AS AN INDUSTRY group with a presence in both Europe and North America, the Bio-Process Systems Alliance (BPSA) welcomes this opportunity to reflect upon the unprecedented growth of SUT adoption over the past decade. More importantly, for the readers of European Pharmaceutical Review, we would also like to offer a cogent view of what may lie ahead. If “what is past is prologue” there is a robust future for SUTs, provided that innovation, risk management, continuous improvement investments, product enhancements and sustainable practices continue to be implemented.

The BPSA mission
Reflecting a little; since BPSA’s inception in 2005, we have viewed the accelerated be in double-digit CAG territory – and also ‘sustainable’ in the context of its merits adoption of SUTs as a global endeavor. This goal is, and always has been, evident in our mission statement, which remains: “Advancing Single-Use Worldwide”. Though our business presence is based in Washington, DC, a key element of our strategic intent is to be a global industry association, focusing on the key features and benefits of polymer-based bioprocessing.

Looking ahead: sustained SUT growth beyond 2020
Perspectives on what lies ahead can be garnered by addressing the duality of the question: “is single-use sustainable?” The issue of sustainability can be viewed in terms of maintaining its impressive growth and adoption numbers – now estimated to as a high-performance, environmentally friendly alternative or hybrid supplement to traditional steel systems.

The answer in both cases is yes; provided that the industry continues to be problem solvers of the first order – and this includes staying on top of end-user risk mitigation issues and addressing and promoting its environmental sustainability benefits.

Healthy business growth has not been granted to the SUT business because SUTs are new and better – the hard-earned industry growth of SUT is due to consistent and effective industry collaborations (along with international regulatory and standards bodies) that have addressed common problems, or hurdles, to the adoption of SUTs; including managing a paradigm shift from steel to polymers – a significant and unprecedented transition of process methodologies.

These collaborations have focused on risk reduction around critical matters, including system leak integrity, change control management, resin consistency, extractables data, particulates identification and control, workforce training and education and now sustainability in its many iterations.

Based on these problem-solving efforts, SUT adoption continues to evolve as a safe, efficient and affordable bioprocess platform. Furthermore, looking ahead, as current traditional manufacturing systems approach an age where significant equipment re-purchase must be carried out or a line must be upgraded, or a new facility built to improve efficiency or to increase output; transition to single-use manufacturing lines will increase due to the need to produce new drugs or therapies quickly, with the flexibility and speed-to-market benefits that SUT provides. The future is bullish and preparation for new markets and new challenges is key.

The emergence of cell and gene therapy (CGT) markets: new SUT opportunities
And prepare we must. Beside the anticipated continued growth in traditional single-use – ie, large-molecule bioprocessing – on the horizon, there are now new markets for SUTs, as exemplified by the emerging field of CGTs. Much has been written and discussed about CGT promises and challenges. Scalability, automation and cost-minimisation are key drivers prior to commercialisation of CGT (along with regulatory hurdles) and CGT cures will only happen inside of precision plastics systems, which are yet to be invented. These challenges are addressed in a BPSA whitepaper which fully addresses and dissects the technical challenges of scaled CGT manufacture.

To clarify, CGT, as with large-molecule bioprocess, shares patient safety as a firstorder concern, with little margin for error. Patient-specific therapies will re-double the scrutiny needed for particulate control, extractables, leak integrity, operator training, logistics, lead times and process control. Is the SUT supply base ready? Again, if past is prologue, the SUT supply base will again step up to these urgent challenges through collaborative innovation and co-operation, making curative therapies available to the acutely and chronically ill at accessible prices.

Future SUT challenges: the duality of sustainability and post-use disposal
Returning to the ‘S Word’ – sustainability: It’s here to stay. We’re all aware that SUTs are diverse systems inclusive of many types of polymers, silicones and thermo-plastics. There is no question, in a world awash with used plastic in landfills, rivers, oceans and storm systems, that the SUT industry must deal with matters of sustainable corporate practices and sensible disposal of post-use waste, ie, smart disposal.

As a caveat, in our growing market sector there is still no firm number of the pounds or kilos of used plastic that can be tied to SUT production and use. Overall, however, plastics are experiencing an unprecedented public relations drubbing. A quick visit to www.ibanplastic.com (and there are hundreds of similar sites) reveals that one million plastic bottles are bought every minute, 500 million straws are given out every day and an estimated four trillion plastic bags are used worldwide annually, with just 1 percent of them being recycled. None of these statistics are verifiable, but the pictures we have all seen tell the story: harmed wildlife, dirty rivers and Pacific Ocean plastic “gyres.” How much of that is SUT-related? We don’t know, but we hope it is minimal.

To further the challenge, sustainability in SUTs has two elements: the sustainable merits of SUT as employed in a process (ie, sustainable use) and the need for environmentally-sound, post-use disposal (smart disposal).

In terms of sustainable use, SUTs offer clear benefits. Extensive lifecycle analyses (LCA) of plastics versus steel systems have been carried out, which indicate that in many cases, SUTs can lead to a reduction in water depletion, climate change, ozone depletion and human toxicity, among others. When using SUTs there may be a reduction of water for injection, process water and steam, as well as fewer requirements for cleaning and sanitation in place. Consequently, there is a common belief that single-use processes are, in fact, sustainable compared to alternatives. Overall, LCA studies have revealed that single-use process technology is often less environmentally impactful than traditional metal processes, with some exceptions based on a combination of geography and process scale. It is indeed a complicated issue.

In terms of smart disposal, polymeric bioprocess systems are mixes of component polymers, which present a challenge to recyclers. End-of-life options (besides recycling) include landfill, incineration and pyrolysis, each of which offers benefits and problems. So, what are ‘end of life’ options for our waste plastics? Probably a combination of the above. The BPSA has formed a Sustainability Council, which meets bi-monthly to address these issues and expects to publish two guidance documents around sustainability in Q4 of 2019. Please stay tuned and visit our website for further information.

Final perspectives
It has been said that “single-use saves” – it saves time, money, resources and lives. For these compelling reasons, and others, it does appear that SUTs are poised for market growth well into the next decade – provided the industry remains focused on the mission to innovate, invest and collaborate, with an eye on sustainable practices.

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.