Bill Hartzel (director of strategic execution for advanced delivery technologies, Catalent Pharma) 1:30–1:55 pm Reducing the Risk Associated with the Filling of Biologics with Advanced Aseptic Processing Hartzel discussed leveraging “blow–fill–seal†(BFS) aseptic processing technology to reduce risks associated with biologics fill and finish. A number of drug recalls have been associated with microbial and particulate contamination of glass vials, problems that could be solved using BFS. Automation eliminates human intervention at this critical stage, driving out associated risks. Hartzel…
Author Archives: Martin Hofmann
Case Study: Overcoming the Design Challenges of Expanded Bed Adsorption Column (Video)
Design and Manufacture of cGMP, Scalable Expanded Bed Adsorption Chromatography Columns
Expanded Bed Adsorption chromatography (EBA) allows clarification and direct product capture in one unit operation. Upflow conditions achieve a fluidized bed, twice the volume of the settled bed. Crude, high cell density and highly-viscous feed streams such as cell culture, foods and plasma are injected upflow. Cells, cell debris, host cell proteins (HCP’s) and DNA leave the expanded bed, whilst the target molecule is bound to the media. In order to facilitate a renaissance in EBA, columns built to current…