Controlling Cryoinjury in Cell Therapy: From Freezing, Formulation Design to Clinical Readiness

Cryopreservation is a critical operation in the manufacture, storage, and distribution of cell therapy drug products. Achieving consistent post-thaw performance requires coordinated optimization of formulation composition, freezing-process parameters, and temperature handling throughout the product lifecycle. This presentation describes an integrated framework for developing robust cryopreservation strategies for T-cell and CAR-T products, combining cryoformulation characterization with controlled-rate freezing and scale-up studies.

The presentation will discuss the key principles behind formulation development and characterization, freezing process parameters like influence of ice-nucleation temperature, cooling rate, fill volume, cell concentration, and container configuration and their impact on product quality.

In addition, the presentation will address product-specific temperature sensitivity during storage, shipping, and handling. Understanding intracellular glass-transition behavior can help define allowable warming limits and prevent quality loss caused by partial warming events. Together, these formulation, freezing process, and thermal-management principles provide a practical, data-driven approach for improving dose recovery, maintaining critical product quality attributes, and supporting scalable, clinically ready manufacturing of advanced cell therapy products.

Presented by Nirnoy Dan, PhD. Senior Scientist at AstraZeneca

Nirnoy Dan, PhD, is a pharmaceutical scientist specializing in biologics drug product development, with expertise in cell therapy, mRNA-lipid nanoparticles, antibody-drug conjugates, and advanced drug delivery systems. He is currently a Senior Scientist in Cell Therapy Drug Product Development at AstraZeneca, where he leads formulation, cryopreservation, closed-system processing, filling, freeze-thaw, scale-up, and technology-transfer activities for autologous and allogeneic cell therapy products.

Dr. Dan has extensive experience developing controlled-rate freezing processes, defining critical process parameters, conducting risk assessments and design-of-experiments studies, and supporting GMP manufacturing. He has authored IND-enabling reports, standard operating procedures, batch records, and technical documentation aligned with cGMP requirements.

He earned his PhD in Pharmaceutics from the University of Connecticut, where his research focused on cryopreservation processes and formulations for T cells. His work also included cell and mRNA-LNP lyophilization, nanoparticle characterization, and gene-delivery systems. He previously completed an MS in Pharmaceutical Sciences at the University of Tennessee Health Science Center, conducting research on antibody-drug conjugates and therapeutic nanoparticles.

Dr. Dan has published in peer-reviewed journals and presented at major pharmaceutical conferences. His professional interests include translating innovative formulation and process technologies into robust, scalable, and clinically ready drug products for advanced therapies.