Author Archives: Eric Isberg

Advanced Materials in Bioprocessing

The choice of materials to develop and process biopharmaceutical products has a significant influence on the quality and purity of those products. Biomanufacturers have benefited from their use of both stainless-steel and single-use materials for individual process components and entire process systems. But careful attention must be paid to material characteristics. Working with different single-use plastics, for example, means that biomanufacturers must take product-contact issues into account, including the risk of extractables and leachables. To celebrate its 20th anniversary, BioProcess…

Optimizing Bulk Drug Substance Storage and Shipment: Key Considerations for Rigid Container Design

When choosing a container for critical drug substances, the material of construction should be your first consideration. It is arguably the most important indicator of container success. Fluoropolymer containers such as Purillex bottles are an excellent choice for BDS storage, freezing, and shipment because of their proven physical and performance advantages. This special report outlines robustness testing of fluoropolymer BDS containers focusing on extractables and leachables, container–closure integrity, durability, gas permeability, and performance during freezing and thawing. Fill out the…

Freeze Cycle Testing of
Fluoropolymer Bottles

Frozen storage of bulk drug substances (BDS), including bioprocess solutions, vaccines, blood components, and other delicate process fluids is common in the bioprocess industry. Vessels used to store those fluids must be capable of withstanding long-term storage in extremely cold temperatures (e.g., –85 °C or –196 °C), sometimes for very long time periods. They also must also maintain integrity after repeated thawing and subsequent refreeze. The study below was performed to characterize performance of fluoropolymer bottles with standard and two-piece…

Benefits of Fluoropolymers for Frozen Storage of Bulk Drug Substance

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 temperature is 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, which…