May / June 2024

Message From the Chair: ATMPs and Biotech in 2024

Scott W. Billman
Scott W. Billman

It is hard to believe that we are halfway through the year for the ISPE programs and the Board of Directors in 2024. We have continued to progress through the 2023–2025 ISPE Strategic Plan with engagement from Chapters, Affiliates, the ISPE Foundation, and ISPE committees and volunteers.

The professional society was built and is run by its amazing volunteers. ISPE’s communities of practice (CoPs), training, and guidance documents come from the dedication and energy of the volunteer membership. All the Chapter, Affiliate, and international leadership and committee chairs are volunteers who dedicate their free time to support and share their knowledge across the membership. In each issue, we spotlight some of those volunteer members. Please make sure to check out those articles in this issue.

New Guidance

The biopharmaceutical issue of Pharmaceutical Engineering® is always a publication filled with interesting articles. Biopharmaceutical manufacturing and the challenges and advances in that area have been at the core of ISPE and throughout the history of our trainings, publications, and discussions. You will find several articles on advanced therapy medicinal products (ATMPs) in this issue of PE. They range in topics across the basic discovery, technical steps in manufacturing, and how to document and manage risk in the manufacturing of these therapies.

Biopharmaceutical topics in this issue include the basic discovery, technical steps in manufacturing, and how to document and manage risk in the manufacturing of these therapies.

At the beginning of 2024 ISPE published two new guides in this area: the ISPE Guide: ATMPs - Allogeneic Cell Therapy and the ISPE Guide: ATMPs - Recombinant AAV Comparability & Lifecycle Management. These guides are in addition to the original ISPE Guide: ATMPs - Autologous Cell Therapy. At the end of 2023, the third revision of the ISPE Baseline® Guide Vol 6: Biopharmaceutical Manufacturing Facilities was published. In addition, ISPE has developed training courses in the areas of biotechnology and ATMPs. These trainings come from our dedicated volunteers and through the biotechnology and ATMPs CoPs.

The 2024 ISPE Biotechnology Conference will be held in Boston, Massachusetts, 17–18 June.

2024 Conferences

The 2024 ISPE Europe Annual Conference in Lisbon, Portugal, was another great forum for our membership to get together and share their thoughts on the industry. We were able to hear industry experts speak on topics like digital transformation projects, artificial intelligence (AI) use cases, sustainability, and perspectives from regulators. Through the ISPE Foundation Grant program, we again sent students and recent graduates to the conference, free of charge, to engage with ISPE membership and learn more about the industry. It is only through the generous donations from members and corporate sponsors that we can continue to grow this program. It has been an invaluable benefit to those who have been able to participate.

We will once again come together to discuss biotechnology and ATMPs at the 2024 ISPE Biotechnology Conference in Boston, Massachusetts, 17–18 June. This will be a place for our membership to get together and engage on these topics, and many more. We will have sessions across the spectrum of biotech technologies, facilities, manufacturing, AI, and sustainability.

I have been amazed at the variety of topics and the level of expertise and interaction I have seen at the local and international conferences and events this year. As a longtime member and volunteer with ISPE, this year has seemed to be full of new and exciting topics. The continued advancement of our digital journey, and the growing use of AI, is a topic generating a lot of buzz and engagement.

Hearing how others in the industry are thinking about this and discussing use cases and the future potential has been great. I look forward to more interaction with the membership on topics like AI, Annex 1, and biopharmaceutical manufacturing as the year continues. I hope you enjoy the articles in this issue, and I look forward to talking with you at an upcoming conference.