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Frozen storage of mAbs at elevated temperatures: Balancing stability and sustainability
Ricarda Nagel1, Nadine Baumeister1, Astrid Hauptmann2
1Pharmaceutical Technology and Biopharmaceutics, Department of Pharmacy, Ludwig-Maximilians-Universität München, Butenandstraße 5-13, 81377 Munich, Germany.
International Journal of Pharmaceutics: X
|July 24, 2026
Summary
Storing protein drug substances (DS) at -40°C is as effective as -70°C for maintaining physical stability. This finding supports sustainable energy use by enabling higher frozen storage temperatures without compromising drug quality.
Area of Science:
- Biopharmaceutical drug substance stability
- Protein formulation science
- Cold chain logistics
Background:
- Conventional storage of protein drug substances (DS) relies on ultra-low temperatures (-70 to -80°C) to mitigate risks like microbial contamination, agitation stress, and degradation.
- The energy-intensive nature of ultra-low temperature storage presents significant sustainability challenges.
- Optimizing storage conditions is crucial for maintaining the quality and efficacy of biopharmaceuticals.
Purpose of the Study:
- To evaluate the long-term physical stability of immunoglobulin G (IgG)-type monoclonal antibodies (mAbs) at higher frozen storage temperatures (-40°C compared to -70°C).
- To assess the impact of formulation on mAb stability at elevated frozen storage temperatures, including screening minimal excipient formulations.
- To explore the potential for reduced energy consumption in biopharmaceutical cold chain management.
Main Methods:
- Investigated the physical stability of four different IgG-type mAbs under unformulated and formulated conditions at -70°C and -40°C.
- Assessed the stability of a representative mAb at -10°C using minimal excipient formulations.
- Evaluated the role of the glass transition temperature (Tg') as a predictive parameter for stability.
Main Results:
- Physical stability of all investigated mAbs was comparable at -40°C and -70°C.
- Minimal excipient formulations demonstrated reliable preservation of mAb stability even at -10°C, above the glass transition temperature (Tg').
- The difference between storage temperature and Tg' was found not to be a reliable predictor of stability.
Conclusions:
- Storage of protein DS at -40°C is a viable alternative to -70°C/-80°C, maintaining comparable physical stability.
- Minimal formulations can enable stable storage of biologics at temperatures as high as -10°C.
- These findings support the adoption of higher frozen storage temperatures, contributing to significant energy savings and enhanced sustainability in biopharmaceutical manufacturing without compromising drug quality.
