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Manufacturing capacity, complexity and cost are core constraints that limit commercialization of cell and gene therapies, and ultimately patient access. In this Fireside Chat series, join Georgi Makin, VP of Digital & Editorial at Phacilitate and the Germfree team as we discuss the challenges and opportunities associated with delivering cell therapies in a decentralized manufacturing model.
This series consists of 5 panels, including:
- Manufacturing Advanced Therapies: Clinical Center Operational Considerations for Decentralized Manufacturing with Carol Houts (Germfree) and Heather Purvis (Title21 Health Solutions)
- Navigating the Digital Frontier: Considerations for Decentralized Manufacturing of Advanced Therapies with Forrest Brown (Germfree) and Krisha Patel (Assurea)
- Innovating Manufacturing: Navigating the Nuances of Process and Analytical Development for Decentralized Production with Josh Ludwig (ScaleReady) and Stuart Curbishley (Adthera Bio)
- Partners in Progress: Shaping the Future of Childhood Cancer Treatment with Stephanie Heathman (Opie Jones Foundation)
- Constructing Capabilities: Holistic Infrastructure Development in Decentralized Manufacturing with Sean Bartholomew (Germfree) and Grayson Heller (cGMPnow)
Fireside Chat 1: Manufacturing Advanced Therapies: Clinical Center Operational Considerations for Decentralized Manufacturing
This first panel features insights from Carol Houts (CSO, Germfree) and Heather Purvis (Director of Clinical Operations, Title21 Health Solutions), as they discuss the operational intricacies of the recently-announced partnership between Germfree and Title21 Health Solutions.
Discover the collaborative efforts of both companies as they integrate innovative manufacturing infrastructure with regenerative medicine-focused software. This partnership aims to streamline the intricate process of advanced therapies production, allowing healthcare professionals to concentrate on delivering patient-centered care. Explore the practical solutions offered by this collaboration, addressing logistical challenges and contributing to the evolution of healthcare manufacturing.
Panel 2: Navigating the Digital Frontier: Considerations for Decentralized Manufacturing of Advanced Therapies
The second panel features insights from Forrest Brown (VP Client Services, Germfree) and Krisha Patel (Co-Founder, Assurea), as they delve into the intricacies of decentralized manufacturing.
Krisha emphasizes the need for swift adoption of digital systems, focusing on building validation processes and internal strategies, before Forrest addresses challenges related to automation and digital systems, emphasizing the importance of change control.
They go on to discuss key regulatory considerations and validation strategies for the decentralized manufacturing of gene therapies. Looking ahead, they anticipate a future where cybersecurity becomes a paramount focus, and interconnected systems enable better process characterization and real-time release of products. Watch the full session, below.
Panel 3: Innovating Manufacturing: Navigating the Nuances of Process and Analytical Development for Decentralized Production
In this third panel, Josh Ludwig (Global Commercial Director, ScaleReady) and Stuart Curbishley (Chief Manufacturing & Development Officer, Adthera Bio) explore the intricate challenges in transitioning cell therapy processes from research to Good Manufacturing Practice (GMP) compliance. Themes such as tool selection, scalability, digital solutions, supply chain logistics, regulatory compliance, raw materials, equipment standardization, and innovative training methods are discussed.
Stressing the significance of early validation, adherence to regulatory standards, and process optimization, the dialogue provides insights into the complexities of achieving GMP compliance in decentralized manufacturing settings for cell therapies.
Panel 4: Partners in Progress: Shaping the Future of Childhood Cancer Treatment
In this fourth panel, Stephanie Heathman (Business Development Lead, Opie Jones Foundation) discusses the Opie Jones Foundation’s mission, inspired by Opie, the 9th pediatric patient in Europe to receive a commercialized CAR-T therapy. The foundation supports families going through childhood cancer, advocates for CAR-T as early treatment, and addresses challenges like information gaps and financial barriers.
Stephanie goes on to explain how partnerships with patient advocacy can have real-world impact on patients and their families.
Panel 5: Constructing Capabilities: Holistic Infrastructure Development in Decentralized Manufacturing
This fifth and final panel with Sean Bartholomew (Biopharma Applications Engineer, Germfree) and Grayson Heller (COO, cGMPnow) discuss the considerations for decentralized cell therapy manufacturing. The key points include the importance of designing identical and cloned processes, focusing on a copy-paste model for multiple locations.
These Fireside Chats were produced in partnership with Germfree.
