The Advanced Regenerative Manufacturing Institute’s (ARMI) mission is to advance cell- & tissue-based therapy manufacturing to be scalable, affordable, and accessible for patients. ARMI will present its progress and that of its members in overcoming the overlooked challenges of scalability and cost-efficiency that have perennially limited commercialization. Presentation will include case studies from actual production of cell therapy products in a GMP-compliant environment including cost-effectiveness, process repeatability, and control strategies.

Point-of-Care (POC) manufacturing carries substantial challenges for academic hospitals but also tremendous benefits. Initial investments include not only expensive cGMP infrastructure but also highly trained staff and sophisticated analytical capabilities. Once overcome, however, POC manufacturing simplifies logistics, reduces cost, and most importantly, increases access for patients, which should be the ultimate goal for these exciting, novel therapies. Regulatory advances can also help democratize this approach.

The promise of AI-powered productivity is so appealing, especially this economic season. Retrieving information from unorganized data, identifying variables predictive of manufacturability, optimizing process parameters, and minimizing spend— the opportunities are endless. Regulation of AI is in its early days, and technologies vary greatly in reliability, privacy, compliance, and optimization strategy. Ask questions when selecting AI technology and implementation framework to protect your IP, ensure compliance, and increase productivity.

This presentation will discuss the transition of cell therapies from academic research to Good Manufacturing Practice (GMP) compliant production. It will cover critical aspects such as process standardization, scalability, and compliance with regulatory frameworks. The session will emphasize the importance of integrating quality assurance throughout development to meet GMP standards. Strategies for effective collaboration between academic institutions and manufacturing facilities to ensure smooth translation will also be explored.

This presentation will examine the translation of novel cell therapies from laboratory research to clinical trials. It will focus on key phases including process optimization, scale-up challenges, and regulatory compliance. The discussion will emphasize the critical steps involved in moving from experimental protocols to standardized clinical applications, ensuring safety and efficacy.

As cell therapy scales, automation remains both a challenge and a necessity. This presentation explores the evolving strategies used to streamline manufacturing, from modular systems to fully integrated platforms. Attendees will gain insight into the diverse approaches taken, key hurdles faced, and how automation may shape the future of this rapidly growing field.

• Examine the limitations of ex vivo CAR T manufacturing and why in vivo approaches are gaining traction.
• Explore current delivery platforms—from viral vectors to lipid nanoparticles—enabling in vivo CAR T cell generation.
• Address CMC considerations unique to in vivo CAR T, including vector characterization, dosing precision, and release testing.
• Discuss the regulatory, safety, and scalability challenges that must be overcome to bring in vivo CAR T therapies to patients.​

• Explore the late-stage drug product development challenges unique to cell therapies, from harvest through infusion
• Discuss strategies for effective technology transfer across multiple manufacturing sites
• Address key considerations in scaling up and standardizing processes to meet commercial demands
• Examine the integration of supply chain planning with clinical and commercial production goals​

IPSC-derived cell-based products are defined as autologous, allogeneic, or xenogeneic cells that have been expanded, selected, or otherwise altered in biological characteristics ex vivo. Due to the complexity of these therapies, the reproducible and consistent manufacturing of cell-based products remains challenging. I will provide insight to address common manufacturing challenges that include phase-appropriate product and process development focusing on key principles of CGMPs, QbD approach, and risk assessment.

Dr. Dhruv Sareen will present strategies to overcome cGMP bottlenecks in the scalable manufacturing of both unmodified and genetically modified iPSC-derived cell therapies. His talk will focus on innovations developed at the Cedars-Sinai Biomanufacturing Center to accelerate clinical translation in regenerative medicine. Key highlights include:

1. Development of GMP-grade iPSC master cell banks

2. Engineering of immune-evasive iPSC lines for allogeneic use

3. Scalable automation of iPSC generation and differentiation 

4. Deep genetic characterization and genomic stability testing    

5. Academic-industry biomanufacturing partnerships supporting IND-enabling studies

This session emphasizes quality, scalability, and translation of advanced iPSC-based therapeutics.

HebeCell’s proprietary protoNK platform is a first-in-class scalable technology for manufacturing PSC-NK cells. PSC-derived cell products are often made in small batch sizes. NK cells are notoriously sensitive to cryopreservation. The final product has a short shelf life. These presented significant challenges to the bioprocessing. In my presentation, I will highlight our solutions to address these challenges and produce NKs with cytotoxic potency to achieve better clinical outcome.

Using a clinical-stage tumor-infiltrating lymphocyte manufacturing process as a model, we adapted a static baseline process into a dynamic system capable of integration with analytical soft sensors such as Raman spectroscopy. Metabolomic profiling of spent media identified ~50 metabolites with a significant effect on cell expansion. These were investigated in a large DoE, the results of which provide an improved understanding of these CPP effects on cell expansion and T cells reactivity within the selected design space and has enabled the development of chemometric and mechanistic models.