Event Detail
Single-use membrane chromatography: novel applications and regulatory guidelines
July 23, 2009
- Web Seminar MD UNITED STATES
PDA
Single-use membrane chromatography has gained considerable speed in recent years in biomanufacturing due to a growing bottleneck that lies with downstream processing. As developments in fermentation and cell culture processes lead to increasing titers of therapeutics, clarification and purification schemes must be re-evaluated to accommodate for the higher amounts of product and impurities. As operational costs continue to escalate, companies are also looking at single-use technologies to reduce fixed costs and downtime in their facilities. Membrane chromatography is a promising solution to easing the downstream bottleneck. The macroporous structures of a membrane adsorber allow for faster processing and also eliminate diffusion limitation. With the capacity for high flow rates, membrane adsorbers have been shown to be extremely effective in flow-through applications. Contaminants such as nucleic acids, host cell proteins, and especially viruses can easily diffuse into the large pores to the active binding sites. Although membrane adsorbers are still chromatography devices, the unique format has sparked questions regarding the operation, validation, and quality assurance for membrane adsorber performance. This presentation will seek to answer some of those questions and provide a guideline for reasonable quality assurance tests, as well as provide an overview of potential applications for disposable membrane chromatography.