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Safety Considerations for Gas Filtration in High-Temperature and Oxygen Enrichment Applications

Gas filtration using sterilization-grade filters is a key part of the production, manufacturing and packaging process of biopharmaceuticals and other products. While it may seem a simple step, there are major safety considerations that have to be taken in to account to protect staff, equipment and facilities from hazard, particularly when working in high temperature and oxygen enrichment applications. This paper examines the safety issues involved, looks at material design considerations and introduces a ready-made solution for safe, effective, robust…

Monoclonal Antibody Production: Viral Clearance and Host Cell Protein Reduction Using a High Capacity Single-Use Strong Anion Exchange Device

Strong anion exchange (Q) chromatography is an industry standard for polishing purification steps of mAb production. It is a proven technology which removes viruses, and host cell proteins from process feed streams in flow through mode. NatriFlo HD-Q devices adsorbers feature a hydrogel membrane which combines high dynamic binding capacity and salt tolerance to deliver best-inclass performance. This makes it possible to rapidly process large sample volumes using a small disposable device. This article examines the ability of NatriFlo HD-Q…

Monitoring Protein Unfolding and Refolding

Proteins exist in a highly ordered, folded state. This highly ordered structure of a protein is integral to the efficacy and safety of a protein-based biotherapeutic. Protein unfolding and refolding are an indicator of protein stability. As a protein begins to unfold, the hydrodynamic radii of the protein species change. Denaturation of proteins may range from slight and reversible conformational changes to a drastic loss of solubility, leading to irreversible aggregation. Monitoring the stability of the different protein conformations is…

Changing Column Packing from an Art into a Science

Chromatography is often the most critical step in biopharmaceutical downstream processing because of its role as the engine for separating impurities from target biologics. The most demanding operation in production scale chromatography is typically packing the column in a way that ensures first time success and a validation result which meets the batch record standards. Traditionally column packing has been the responsibility of a few specialist operators and has been regarded almost as an art by most observers. When the…