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Prediction of frozen virus stability based on degradation mechanisms, real-time data and modeling: Supplementary tables

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posted on 2022-10-24, 08:40 authored by Ying Homan, Daniel Rosenbloom, Sally Wong, James Lucchese, April Li, Sheri Dubey, Justina Thomas, Gino Salituro, Roy Helmy, Thorsten Verch

Aim: Critical virus reagents in regulated bioanalytical assays require stability monitoring. Although

stability at ultralow frozen temperatures is generally assumed, published data are limited and realtime

studies are time consuming. Materials & methods: The authors reviewed literature data, typical

mechanisms of molecular degradation, glass transition temperatures of commonly used buffers and

available real-time storage data to model frozen virus reagent stability. Results: Storage at ultralow

temperatures below the glass transition temperature was critical for virus stability. Modeling of real-time

data suggested that virus potency remained within 0.5 log10 of its starting potency at a probability of >99,

90 and 73% after 10, 20 and 30 years, respectively. Conclusion: The study supports the practice of virus

storage at -70◦C or below for 20–30 years.


The research was supported by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (NJ, USA). The authors are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (NJ, USA) and may be eligible for stock options or have stock ownership in Merck & Co., Inc. (NJ, USA).