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…

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…

Hyaluronic acid (HA)-based solutions are traditionally difficult to filter, due to their high viscosity. Many users have found sterile filtration of hyaluronic acid solutions very challenging to implement, from both an economical, as well as a practical standpoint. This White Paper evaluates commercially-available sterilizing-grade products for filtration of HA and explains how sterilizing-grade filters can offer a highly efficient, economical solution even under the worst-case bacterial challenge conditions. It outlines how the combination of various properties of HA-based solutions and…