Container system for enabling commercial production of cryopreserved cell therapy products

Regenerative Medicine
Erik J WoodsVinod D Vilivalam

Abstract

The expansion of cellular therapeutics will require large-scale manufacturing processes to expand and package cell products, which may not be feasible with current blood-banking bag technology. This study investigated the potential for freezing, storing and shipping cell therapy products using novel pharmaceutical-grade Crystal Zenith((R)) (CZ) plastic vials. CZ vials (0.5, 5 and 30 ml volume) with several closure systems were filled with mesenchymal stem cells and stored at either -85 or -196 degrees C for 6 months. Vials were tested for their ability to maintain cell viability, proliferative and differentiation capacity, as well as durability and integrity utilizing a 1-m drop test. As controls, 2 ml polypropylene vials were investigated under the same conditions. Post-thaw viability utilizing a dye exclusion assay was over 95% in all samples. Stored cells exhibited rapid recovery 2 h post-thaw and cultures were approximately 70% confluent within 5-7 days, consistent with nonfrozen controls and indicative of functional recovery. Doubling times were consistent over all vials. The doubling rate for cells from CZ vials were 2.14 + or - 0.83 days (1 week), 1.84 + or - 0.68 days (1 month) and 1.79 + or - 0.71 days (6 months), whic...Continue Reading

Citations

Jul 19, 2013·Applied Radiation and Isotopes : Including Data, Instrumentation and Methods for Use in Agriculture, Industry and Medicine·Alicia K LeeceUmar Mahmood
Sep 28, 2012·Clinical and Experimental Medicine·Patricia Gálvez MartínBeatriz Clares Naveros
Jan 24, 2013·Expert Opinion on Biological Therapy·Sreedhar ThirumalaErik J Woods
May 14, 2011·Transfusion Medicine and Hemotherapy : Offizielles Organ Der Deutschen Gesellschaft Fur̈ Transfusionsmedizin Und Immunham̈atologie·Charles J Hunt
May 14, 2011·Transfusion Medicine and Hemotherapy : Offizielles Organ Der Deutschen Gesellschaft Fur̈ Transfusionsmedizin Und Immunham̈atologie·Erik J Woods, Sreedhar Thirumala
May 23, 2017·BioTechniques·Lloyd WaxmanVinod D Vilivalam
Apr 16, 2020·Advanced Biosystems·Roaa AlnemariMohammad A Qasaimeh
Dec 12, 2020·Journal of Pharmaceutical Sciences·Dhananjay JereHanns-Christian Mahler
May 1, 2021·Frontiers in Cell and Developmental Biology·Premkumar JayaramanMohan C Vemuri
Jun 28, 2019·Transfusion Medicine and Hemotherapy : Offizielles Organ Der Deutschen Gesellschaft Fur̈ Transfusionsmedizin Und Immunham̈atologie·Charles J Hunt

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Methods Mentioned

BETA
flow cytometry

Software Mentioned

CellQuest
Computype

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