This session examines the technologies and infrastructure required to scale and deliver cell-based therapies. It highlights advances in manufacturing, including automation, closed systems, and quality control strategies that enable consistent production at clinical scale. It also explores innovations in biopreservation, such as improved freezing methods and assay-ready cell platforms, designed to enhance post-thaw viability and support long-term storage and distribution.
Speakers will further address key translational challenges, including scalability, supply chain constraints, and maintaining cell quality from manufacturing through delivery, with the goal of enabling reliable, on-demand access to regenerative therapies.
Session Chairs:
- Natalie Livingston, Massachusetts General Hospital
- Uzair Rajput, Instant Systems Inc.
Speakers:
- "Advancing Scalable Manufacturing of iPSC-Based Cell Therapies: Innovations, Automation, and Quality Integration"
Julie Allickson, Mayo Clinic - "ThawReady Biopreservation: An Innovative Platform for Providing Assay-Ready Cells for Cell Therapy Applications"
Nilay Chakraborty, ATCC - "Clinical Scale Cryopreservation of Pancreatic and Stem Cell Islets for Transplantation"
Erik Finger, University of Minnesota - "Manufacturing of Cell-based Therapeutics"
Johnna Temenoff, Georgia Tech/Emory University
This session is part of the Biopreservation Technologies Track.
Presentation Details
Julie Allickson, PhD
Chief Technology Officer
Center for Regenerative Biotherapeutics
Mayo Clinic
"Advancing Scalable Manufacturing of iPSC-Based Cell Therapies: Innovations, Automation, and Quality Integration"
Scaling up the production of induced pluripotent stem cell (iPSC)-derived therapies is essential for their clinical and commercial success. Key innovations include the adoption of automation and closed systems to improve process robustness and compliance with GMP standards. Integrating quality-by-design (QbD) and process analytical technology (PAT) supports consistent product quality, real-time monitoring, and efficient process control. Strategic selection of bioreactor platforms, early process characterization, and the implementation of advanced analytics are critical for addressing the diverse requirements of iPSC-derived products. Modular technologies and artificial intelligence are poised to further enhance the scalability, efficiency, and regulatory compliance of cell therapy manufacturing.
Bio: Julie Allickson, Ph.D., is the Chief Technology Officer at Mayo Clinic’s Center for Regenerative Biotherapeutics and holds the Otto Bremmer Trust Directorship in Biomanufacturing and Process Development. She also a consultant for Laboratory Medicine and Pathology and serves as an associate professor of regenerative medicine. Dr. Allickson oversees external collaborations critical to product development, aligning with Mayo Clinic's 2030 vision. With over 25 years of expertise in cellular therapy and regenerative medicine—including cell and gene therapies, tissue engineering, and 3D bioprinting—she is dedicated to advancing Mayo Clinic’s leadership in the field. Dr. Allickson earned a B.S. and M.S. in Medical Laboratory Sciences, focusing on Clinical Immunology, and a Ph.D. in Health Sciences. Her background includes business management, strategic planning, and project management, with experience in both industry and academia, notably as an executive officer at a cell banking company. The center operates in Minnesota, Arizona, and Florida, emphasizing innovative therapies and commercialization.
Nilay Chakraborty, PhD
Director of Cryobiology
Principal Scientist
ATCC
"ThawReady Biopreservation: An Innovative Platform for Providing Assay-Ready Cells for Cell Therapy Applications"
The rapid development of cell therapy necessitates high-quality, ready-to-use cellular materials. Conventional cryopreservation methods frequently result in suboptimal post-thaw viability, inconsistent outcomes, and diminished potency, creating substantial challenges for both research and manufacturing within the field of cell-based therapies. ThawReady biopreservation represents an innovative platform technology developed at ATCC to address these essential requirements by providing assay-ready functionality post-thaw, ensuring consistent performance across vials and batches. In contrast to traditional cryopreservation techniques, ThawReady technology is specifically designed to preserve cellular integrity, sustain functional potency and reducing variability in both; thereby reducing recovery time and variability significantly associated with thawing processes.
Bio: Nilay specializes in biopreservation and innovative product development. An engineer by training, Nilay’s work at ATCC focuses on the creation of novel technologies and products. He received his doctoral degree from the University of North Carolina at Charlotte and MBA from Indian Institute of Engineering Science and Technology. He did his postdoctoral work at Massachusetts General Hospital and Harvard Medical School. Nilay’s has 9 patents and over 80 scientific publications. His work led to the creation of two successful startup businesses. Before joining ATCC he was an Associate Professor with tenure at the University of Michigan’s Dearborn campus. He now leads ATCC’s efforts in preservation sciences and new cutting-edge strategic product development.
Erik Finger, MD, PhD
Eunice L. Dwan Endowed Chair for Diabetes Research
Distinguished McKnight University Professor
Professor of Surgery
University of Minnesota
"Clinical Scale Cryopreservation of Pancreatic and Stem Cell Islets for Transplantation"
Pancreatic islet transplantation can restore natural insulin production and offer a potential cure for diabetes. However, its clinical impact has been limited by the unavailability of high-quality islets when and where they are needed. Cryopreservation could provide an on-demand supply, but conventional methods result in poor viability and function after thawing. We developed CryoMesh, a vitrification platform that combines a low-toxicity cryoprotectant with an engineered mesh substrate, enabling ultra-rapid cooling and rewarming for ice-free cryopreservation. CryoMesh enables long-term, clinical-scale preservation of human pancreatic islets and human stem cell–derived islets, maintaining viability, architecture, and insulin secretion. By supporting scalable, on-demand cryobanking, CryoMesh overcomes a major barrier to cell-based diabetes therapy, transforming how cell therapies can be produced, stored, distributed, and delivered worldwide.
Bio: Erik Finger, MD, PhD, is the Eunice L. Dwan Endowed Chair for Diabetes Research, a Distinguished McKnight University Professor, and Professor of Surgery at the University of Minnesota. His research focuses on organ and tissue preservation, with an emphasis on advancing transplantation outcomes. A multi-organ abdominal transplant surgeon specializing in kidney and pancreas transplantation, Dr. Finger is actively involved in clinical transplantation, tolerance trials, and basic research in transplant immunology and organ preservation. He is supported by multiple grants from the National Institutes of Health and the National Science Foundation. Among his recent achievements is the first reproducible long-term cryopreservation of organs, followed by successful transplantation.
Johnna Temenoff, PhD
Wallace H. Coulter Distinguished Chair
Coulter Department of Biomedical Engineering
Georgia Tech/Emory University
"Manufacturing of Cell-based Therapeutics"
As Director of the NSF ERC on Cell Manufacturing Technologies, Dr. Temenoff will share advances in development of new manufacturing technologies for scale-up of potent therapeutic cells, including addressing supply chain issues that may reduce potency after production..
Bio: Dr. Johnna S. Temenoff is a Wallace H. Coulter Distinguished Chair in the Coulter Department of Biomedical Engineering at Georgia Tech/Emory University in Atlanta, GA. She is also currently the Director of the U.S. NSF Engineering Research Center in Cell Manufacturing Technologies (CMaT) and the Director of the Marcus Center of Excellence for Cell Biomanufacturing. Scientifically, Dr. Temenoff is interested in scaling culture of therapeutic cells and tailoring the molecular interactions between glycosaminoglycans and proteins/cells for use in regenerative medicine applications. Her laboratory focuses primarily on promoting repair after injuries to the tissues of the shoulder, including cartilage, tendon, and muscle.
Natalie Livingston, PhD (Session Chair)
F32 Postdoctoral Fellow
Massachusetts General Hospital
Bio: Natalie Livingston is an NIH F32 Postdoctoral Fellow in the lab of Mehmet Toner at MGH. She received her PhD in Biomedical Engineering from Johns Hopkins University, where she worked on the development and characterization of cell-based therapies for immunotherapy. She continues this work now, with a shifted focus towards cell manufacturing and preservation.
Uzair Rajput, MS (Session Chair)
Chief Operating Officer
Instant Systems
Bio: Uzair Rajput is Chief Operating Officer at Instant Systems, where he drives the development of bioprocessing solutions for cell therapy, tissue banking, and biopharma applications. He has been involved with ATP-Bio since its inception, supporting research initiatives. Uzair holds full P&L responsibility and leads Product Development, Manufacturing, Sterilization, Supply Chain, Regulatory, and Quality Systems, with a focus on building a high-performance culture. He brings deep expertise in human tissue banking and organ procurement. Uzair also serves as Chair of the Industry Advisory Board for ATP-Bio and holds a Master’s in Mechanical Engineering from Wayne State University.