BioPhorum Survey on -40 °C Drug Substance Storage Practices

A new BioPhorum publication "Biopharmaceutical drug substance storage" summarizes results from a 2025 cross-industry survey on -40 °C storage practices for biologic drug substance, providing insights into current industry approaches, risks, and best practices.

The survey shows that -40 °C storage has been widely adopted: 85% of respondents use it, and 61% apply it to more than 75% of their biologics. 74% store all protein formats at -40 °C, not just monoclonal antibodies. No unexpected stability issues were reported, though some risks were noted during temperature transitions (e.g. dry ice transport). Regulatory risk is considered low, provided supporting stability data, suitable closures, and comparability studies are in place.

In a news item published on 5 September 2025, it states: "Sub-zero storage of biologics is crucial for maintaining their stability and efficacy. Biologics, including monoclonal antibodies and therapeutic proteins, are sensitive to temperature fluctuations – storing them at sub-zero temperatures preserves their structural integrity and biological activity over time."  The publication "offers an overview of best practices and strategic rationale for -40°C drug substance storage and advancing decision-making in sub-zero cold chain strategy.”

The paper is available for download on the BioPhorum website.