By Raul Valero, Beatriz Menéndez, Maria Reyna-Fernandez, Borja del Rio, Rosalba Rosado, Maitane Ortiz-Virumbrales, Nathan Moore, Alvaro Avivar-Valderas, Vanessa Fernández Gómez, Laura M. Perez, Irene Zamora-Marmol, Eleuterio Lombardo, Taylor Terrio, and Pablo Mancheño-Corvo
Volume 25, Open Access (January 2026)
The number of cellular therapies in clinical trials and on the market has continued to rise significantly in recent years—and so does the need to maintain strict control over all manufacturing steps in order to reduce batch-to-batch variability. One potential source of product variability is the manual thawing of cryopreserved cells in a water bath, which can differ between operators. Additionally, water baths pose a significant contamination risk, making them less suitable for GMP environments. To overcome these challenges, several companies have developed water-free thawing devices that offer better control of the thawing process. However, these devices either accommodate only one vial at a time or lack U.S.
FDA 21 CFR 11 compliance in producing a computer-generated audit trail. Hence, we have developed a novel, water-free and dry-heat-based, fully programmable thawing device that is capable of thawing up to ten vials simultaneously and complies with 21 CFR 11 requirements…
Citation: Valero, R; Menéndez, B; Reyna-Fernandez, M; del Rio, B; Rosado, R; Ortiz-Virumbrales, M; Moore, N; Avivar-Valderas, A; Fernández Gómez, V; Perez, L. M.; Zamora-Marmol, I; Lombardo, E; Terrio, T; Mancheño-Corvo, P. Assessment of a new automatic, water-free thawing device specially designed for the context of the cell therapy industry. BioProcessing Journal 2026, 25. https://dx.doi.org/10.12665/J24OA.Mancheno-1
Posted online January 12, 2026