title: Off the shelf cellular therapeutics: Factors to consider during cryopreservation and storage of human cells for clinical use.
abstract: The field of cellular therapeutics has immense potential, affording an exciting array of applications in unmet medical needs. One of several key issues is an emphasis on getting these therapies from bench to bedside without compromising safety and efficacy. The successful commercialization of cellular therapeutics will require many to extend the shelf-life of these therapies beyond shipping "fresh" at ambient or chilled temperatures for "just in time" infusion. Cryopreservation is an attractive option and offers potential advantages, such as storing and retaining patient samples in case of a relapse, banking large quantities of allogeneic cells for broader distribution and use and retaining testing samples for leukocyte antigen typing and matching. However, cryopreservation is only useful if cells can be reanimated to physiological life with negligible loss of viability and functionality. Also critical is the logistics of storing, processing and transporting cells in clinically appropriate packaging systems and storage devices consistent with quality and regulatory standards. Rationalized approaches to develop commercial-scale cell therapies require an efficient cryopreservation system that provides the ability to inventory standardized products with maximized shelf life for later on-demand distribution and use, as well as a method that is scientifically sound and optimized for the cell of interest. The objective of this review is to bridge this gap between the basic science of cryobiology and its application in this context by identifying several key aspects of cryopreservation science in a format that may be easily integrated into mainstream cell therapy manufacture.
authors.affiliation: Cook Regentec, Indianapolis, IN, USA; Indiana University School of Medicine, Indianapolis, IN, USA; Process and Product Development Subcommittee, International Society for Cellular Therapy, Vancouver, BC, Canada. Electronic address: Erik.Woods@CookRegentec.com.
authors.forename: Erik J
authors.initials: EJ
authors.lastname: Woods
authors.affiliation: Cook Regentec, Indianapolis, IN, USA.
authors.forename: Sreedhar
authors.initials: S
authors.lastname: Thirumala
authors.affiliation: Novartis Pharmaceuticals Corporation, Morris Plains, NJ, USA.
authors.forename: Sandhya S
authors.initials: SS
authors.lastname: Badhe-Buchanan
authors.affiliation: Process and Product Development Subcommittee, International Society for Cellular Therapy, Vancouver, BC, Canada; Charter Medical Ltd, Winston-Salem, NC, USA.
authors.forename: Dominic
authors.initials: D
authors.lastname: Clarke
authors.affiliation: Process and Product Development Subcommittee, International Society for Cellular Therapy, Vancouver, BC, Canada; BioLife Solutions, Bothell, WA, USA.
authors.forename: Aby J
authors.initials: AJ
authors.lastname: Mathew
mesh_terms: D002470:Cell Survival / Q000187:drug effects; D064987:Cell- and Tissue-Based Therapy / Q000379:methods*; D015925:Cryopreservation / Q000379:methods*; D003451:Cryoprotective Agents / Q000494:pharmacology*; D006650:Histocompatibility Testing; D006801:Humans; D033581:Stem Cell Transplantation / Q000379:methods*
chemical_list: D003451:Cryoprotective Agents
keywords: cell manufacturing; cellular shelf life; cellular stability; cellular therapeutics; cryopreservation; stem cell therapy