Communities of Practice Profiles: Meet the Sterile Products Processing CoP

Matthew Gorton, Community of Practice Chair and Director of Business Development at GBA, explained why this is such an important mission. “Sterile products are often introduced to a patient via injection or an infusion, which bypasses the body’s normal barriers to infection: the skin and the gut system. Both are designed to keep the body safe from infection,” Gorton said. “Since products that are considered sterile are introduced in ways to bypass those systems, if they are not produced or stored properly or administered correctly, they can pose a heightened risk to patient safety. The engineering controls, technologies, and regulation that our group discusses are important to ensure that the industry is increasing the quality of medicine that is consumed.”

Varied Topics

Because sterile products processing touches so many areas of the pharmaceutical industry, discussions at events and meetings within the Community of Practice cover a wide variety of topics but are often focused on advanced aseptic processing and trends in aseptic filling, barrier systems, blow-fill-seal, terminal sterilization, and facility and manufacturing process design. The Community of Practice also explores areas such as how to solve drug shortages with engineering and regulatory solutions, robotics in manufacturing, risk-based approaches to quality systems, barrier systems, single-use solutions, environmental monitoring, and the impacts of Annex 1. More recently, the Community of Practice has expanded discussions to include topics around compounding pharmacies and advanced treatments like cell and gene therapy and combination devices.

Jörg Zimmermann

Vice President Vetter Development Service External Affairs

Vetter Pharma Fertigung GmbH & Co KG

“It is usually the small things that we learn during our exchanges that can tremendously help others so you’re not reinventing the wheel but you’re building on what others have already tried,” said Sterile Products Processing Community of Practice Steering Committee member Jörg Zimmermann, Vice President, Vetter Development Service, External Affairs, at Vetter Pharma-Fertigung GmbH & Co., and the 2021–2022 Chair of the ISPE International Board of Directors. “As an example, we were discussing how to use helium instead of nitrogen for overlaying in aseptic processing. My company had experience doing that and I was able to help others in the group by sharing our experience.”

Conference Participation

Gorton said Community of Practice members are very active at ISPE conferences and training courses. They have been members of the teams producing guidance documents including the ISPE Baseline Guide: Sterile Product Manufacturing Facilities (Third Edition).

Three members of the Steering Committee—Chris Schwartz, Senior Consultant, L.E.K Consulting; Jason Collins, Director of Process Architecture, IPS-Integrated Project Services; and Christa Myers, Senior Associate, Aseptic and Sterile Products Market Director, CRB—are presenting an interactive session at the 2022 ISPE Annual Meeting & Expo in Orlando. The session is entitled “Investing in Legacy Facilities: How to Get the Most Bang for Your Buck,” and it will help participants learn how to assess different options for upgrading a legacy sterile manufacturing facility (e.g., transfer to alternative asset, retrofit in place, build adjacent, or build greenfield), and determine how to get the most “bang for your buck” given fixed capital allocations. The presentation will discuss decision points and implications of each option and will include an evaluation of the options against a business case framework to make a robust recommendation to leadership.

Gorton said that events like the ISPE Annual Meeting are a great place to connect with members of the Steering Committee and learn more about getting involved. Collins pointed out that his favorite part about ISPE conferences is that they give him a glimpse of the future. “Every year, technology changes and things get more interesting and by participating in activities, especially the face-to-face meetings and events, you get to see some of that equipment, sometimes on the floor, but often through presentations from vendors as they try to push the envelope on what we can do from an equipment standpoint. At every conference or every meeting, you get to see the coolest things in the industry and that’s exciting.”

Sterile Products Processing Community of Practice Steering Committee members have also traditionally been involved with planning ISPE’s Aseptic Conference (see Figures 1 and 2). Myers, who has been involved with both conferences for a long time, said, “The aseptic, barrier, and containment conference is the most forward-thinking and innovation-focused show that I have seen. The topics, the attendees, and the discussion groups focus on how to get from the current conditions of operations to a better future state while focusing on science behind the challenges. This group is astounding in the way they support each other to achieve highly functional aseptic operations. The level of collaboration for the betterment of the whole industry really makes it a special event.”

ISPE and Sterile Products Processing Community of Practice Benefits

Overall, Steering Committee members said that the best part of being a member of ISPE and the Sterile Products Processing Community of Practice is learning from each other. “The best thing about being a member of the Community of Practice is being part of a community of a lot of people with a lot of expertise,” said Christine Martin, PhD, Associate Director, AbbVie, Inc., another member of the Steering Committee. “Coming from research and development, I really like to discuss what our future looks like, what we have learned from events like the coronavirus pandemic, what challenges we have in the future, if we can in cooperation with the regulatory bodies develop timelines to shorten the approval process, and how we can apply any Lean principles to the industry and still ensure our high-quality standards.”

“Being a part of the Community of Practice gives me the opportunity to review, comment, and contribute on draft regulatory and guidance documents prior to formal release. This access and contribution helps me to be able to take that knowledge back to my organization, apply it, and help biopharmaceutical clients succeed,” said Vince Cebular, Senior Vice President, IPS. Massimiliano Cesarini, Sales Director, Romaco SRL, agreed, “It allows me to bring back the insights, trends, and what we should do next in our field.”

For those wishing to get involved with the Sterile Products ProcessingCommunity of Practice, Gorton said the first step is joining the wider community at ISPE Engage where members can post questions and give advice. From there, he said all Community of Practice members are happy to meet and discuss their work at ISPE events. “We really suggest people meet us. You’re going find us at the Annual Meeting in Florida, and we’re going to be at the Aseptic Conference next spring. We also have several of our team members that lead ISPE trainings in this space, and that’s a great chance to learn some practical knowledge, best practices and operations, and stay on top of the regulatory environments.”

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