Minerva Knowledge and Risk Management

I recently revisited an insightful video by Carol Houts of Germfree, recorded at the Meeting on the Mesa by the Alliance for Regenerative Medicine (Oct. 7–9, 2024) titled "Advancing Patient Access through Decentralized Manufacturing". In it, she makes a compelling case for increasing therapy accessibility, reducing costs, and streamlining regulatory frameworks to bring advanced therapies to more patients. Carol has a novel way of explaining the expansion of current centralized manufacturing toward the end goal of point-of-care (POC) manufacturing. This is a topic I am passionate about. I believe the future of advanced therapy manufacturing will be a blend of centralized, decentralized, and POC on-demand production models. The continuous improvement of each of these models is necessary to satisfy present and future demand: ?? Centralized hubs: Essential for large-scale, high-volume manufacturing. ?? Decentralized sites: Distributed manufacturing closer to the POC but not at the hospital. ?? Point of Care: Manufacturing at the hospital, on demand. One of my goals is transforming advanced therapy manufacturing into a procedure. With advances in visual intelligence, automation, robotics, and AI-driven QC, we can turn therapy manufacturing into something as common as a dialysis procedure, making it available in diverse settings—such as specialty pharmacies, apheresis centers, specialized clinical laboratories, and even medical offices. This is a future I am excited about. I know that together we can push the boundaries to ensure all manufacturing options are available to meet present and future demand. This is a great time for collaboration and innovation! #AdvancedTherapies #CellTherapy #GeneTherapy #Biomanufacturing #DecentralizedManufacturing #PointOfCare #RegenerativeMedicine #ManufacturingInnovation

In response to Andrew Scheffler’s great question on multi-station production lines vs. all-in-one manufacturing systems, here are my thoughts. Both traditional manufacturing lines and all-in-one systems have a role in meeting current and future demand for advanced therapies. Each approach has distinct strengths, and a balanced strategy may be the key to achieving sustainable production. I’ve been actively involved in and have supported the development of all-in-one systems, so I’m sharing a visual to illustrate how it could function in a centralized manufacturing setting. The main difference between these two manufacturing approaches is the balance between systems and people, and their respective activities. For a production of 1,200 10-day batches per year in one shift, a traditional manufacturing line requires about 13 operators and 7 major systems directly producing batches, whereas an all-in-one setup would need 5 people and 40 all-in-one systems. This fundamental trade-off lies in the balance between human interaction and automation. In an all-in-one approach, machines take on a larger share of the workload, reducing manual handling, whereas in a multi-station setup, human activity remains more central. Of course, there are many hybrid models between these two alternatives. What are your thoughts on this trade-off??Also, is the diagram clear enough?

I am enthusiastic about the vision of John Wilson and Wilson Wolf Manufacturing, LLC, emphasizing the importance of a production line approach to increase the capabilities of current CAR-T manufacturing operations to provide more patients with life-saving therapies. A station-based approach is essential, with each station performing specific parts of the process and ensuring line-balancing. To contribute to the conversation with Andrew Scheffler, Ignacio Nú?ez and many others, I created this process map for a CAR-T manufacturing process showing common production times and capacities. Blue lines are references for line balancing. Efficiency-improvement mechanisms shown are fully preassembled kits with aseptic connectors. Connections to transfer materials need to be sterile and prevent backflow to ensure there is no microbial or patient-to-patient cross-contamination. As productivity increases, additional incubators can be added to reduce the impact on temperature and CO2 levels caused by frequent door openings. Automation schemes to increase capacity can be implemented in an evolutionary fashion while keeping critical aspects of the unit operations unaffected. One capacity-increase approach can start with internal automation at each station, as recommended, combined with pre-kitting stations to preassemble all materials and consumables. All of this while planning for the inclusion of movable robots and eventually humanoid robots. I am really excited about the collaborative effort and innovative thinking taking place! Looking forward to hearing your comments on my contribution above!

A big recognition to the panelists from the “How Do We as an Industry Support Rare/Ultra-Rare Diseases” discussion today at ATW 2025! ? Grateful to Deanna Portero, Susan Brisendine (Sikora), Souad Messahel, PhD, Julia Taravella, and Andrea Boitnott for their advocacy and tangible work and advances in the field of rare diseases. ? Your insights and efforts educate and inspire us all to keep pushing boundaries for the benefit of patients and families! #RareDiseases #MinervaKRM #ATW2025 #AdvancedTherapeutics #CellandGeneTherapy

Thoroughly enjoyed the “Transforming Good Science into Sustainable Business: Actionable Strategies for Commercializing Cell and Gene Therapies” workshop this morning at ATW25! I want to highlight Josh Ludwig's vision—calling for more collaboration from all of us professionals to drive the progress of advanced therapies, especially regarding manufacturing at points of care. I believe this is the key for making advanced therapies more accessible, affordable, and timely for patients! Thank you to Josh Ludwig, Boro Dropuli?, Pinar (Ozkan) Cicalese, Elena Maryamchik, MD, MBA, and Jeff Liter for sharing such on-point insights into how we can truly democratize advanced therapies. #AccesibleTherapies #ATW25 #MinervaLRM #AdvancedTherapeutics #CellandGeneTherapy

Very happy to see the amazing work ScaleReady is doing to make point-of-care manufacturing a reality! Happy Cells! ?? #HappyCells #ATW25 #MinervaKRM #GRex #ScaleReady #AdvancedTherapeutics #CellGeneTherapy

Yesterday we had a standout moment at ATW 2025 with the panel “The Power of Investing in Women: Leaders, Innovators, and Investors”. Transforming advanced therapies to benefit patients doesn’t just require gender equality—it demands it. We cannot unlock the full potential of creativity and innovation in our field without equal participation from women and men. ? A huge thank you to Tamika Jackson, Sarah Creviston, Audrey Greenberg, adriana herrera, Lynn Fischer, and Lee Buckler for demonstrating how equity fuels innovation, completes perspectives, and fosters organizational success. Your insights remind us not only of what’s possible, but also of what equity truly looks like. #MinervaKRM #ATW25 #CGT #EquityinCGT #WomeninCGT #Advancedtherapeutics #Celltherapymanufacturing

Exciting times for companies working to bring advanced therapies to points of care! While perspectives still vary, there's growing support from investors who believe in closed manufacturing systems as a way to bring therapies closer to patients. Today's panel discussion, “Investing in Tools, Services, and Propelling CGT Ecosystems,” at Phacilitate's Advanced Therapy Week, highlighted this momentum. A big thank you to Christiaan Engstrom, Troels Jordansen, Irene Rombel, Daniel Friedman, and Bo Wiinberg for sharing your invaluable insights!

Very excited about the upcoming Phacilitate Advanced Therapies Week, January 20-23, in Dallas, and joining the leaders that are catalyzing the cell & gene therapy revolution! Let’s bring therapies to patients, at scale, at point of care! Hope to see you there! #MinervaKRM #ATW25 #AdvancedTherapiesWeek #CGT #CellTherapy #GeneTherapy #Advancedtherapeutics #CellTherapyManufacturing

Great news!