As biopharmaceutical developers embrace single-use technologies to reduce risk, improve process speed, efficiency and flexibility, they have found few options in downstream unit operations.  With the introduction of Natrix hydrogel technology, developers now find a chromatographic tool that provides the binding capacity of the best modern resins, but with ten times higher flow rates. This study illustrates the NatriFlo HD-Q anion exchange adsorber which provides high productivity polishing for monoclonal antibody for GMP manufacturing, including under high conductivity conditions. This…

Single-use bioprocessing is now common for the production of biopharmaceuticals. Existing and future biopharmaceuticals are extremely complex molecules that display structural heterogeneity. This heterogeneity must be carefully controlled in order to deliver consistently safe and efficacious product to patients. The FDA’s Guidance for Industry on Process Validation states that the manufacturer should understand the sources of variation be able to detect variation and understand the impact of variation on the process and ultimately the product. This presentation will review sources…

High throughput (HT) sorbent screening is widely used for developing purification process saving time and sample volume. This study describes the development of a non-protein A purification process for a monoclonal antibody (MAb) expressed in a CHO cell supernatant. For the capture step, 54 process conditions were screened in three days using 200 µL mini-columns packed with five different sorbents. Capacity and yield were evaluated using Bio-Layer Interferometry (BLI) with protein A biosensors and MAb purity, using SEC-HPLC. A 340-fold scale-up of…