Benefits of Fluoropolymers for Frozen Storage of Bulk Drug Substance

摘要

Frozen storage of bulk drug substance (BDS) at temperatures at or below -70°C is common in the bioprocess industry. Storage at temperatures below -80°C can lead to spontaneous failure of typical BDS containers, particularly if container temperatureis reduced rapidly (known as flash freezing).Most containers used to store BDS have glass-transition temperatures well above -196°C, and many containers structurally fail during rapid descent through glass transition. Even worse, such failures often are detected after a container is thawed, whichcan take weeks to months after freezing is completed.