Addressing High Demands for Increased Productivity in Downstream Operations

Protein A is the undeniable workhorse in monoclonal antibody (MAb) purification. In this special report, Geoff Hale shares the history of Protein A in MAb manufacturing, Jonathan Royce of GE Life Sciences shares the innovations that have been made to help biopharmaceutical manufacturers overcome the capacity bottleneck and bioburden concerns, and authors from Gilead Sciences share data from their studies using MabSelect resins to address these issues.

Reimagining Capacity for Today’s Purification of Monoclonal Antibodies
Protein A has made monoclonal antibodies (MAbs) highly manufacturable and easier to develop in laboratories. Its use has enabled purification platform approaches, which have been key elements in growth of the MAb market. But in general, protein A columns are too large, which means that they either limit the use of prepacked technology, or they create a mismatch between a protein A column and downstream operations. Protein A columns also are more prone to bioburden contamination than any other step in a downstream process. Jonathan Royce, global business leader for chromatography at GE Healthcare discusses how manufacturers can increase process productivity by improving resin performance.
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Evaluation of Next-Generation Protein A Chromatography Resin for the Purification of Monoclonal Antibodies
Advancements in fermentation and cell culture technologies have led to significant upstream productivity gains, thus creating risks of potential bottlenecks to downstream processing. Capacity bottlenecks at the protein A step have been addressed through improvements in process conditions, equipment strategies, and protein A ligand and bead technologies. Authors from Gilead Sciences discuss their studies of several GE MabSelect resins, including their dynamic binding capacities, cleaning and sanitization efficiencies, and process performance and lifetime stability.
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Addressing the Risk of Bioburden and the Need for Increased Productivity in Protein A Chromatography
Jonathan Royce, global business leader for chromatography at GE Healthcare highlights the development of GE’s new MabSelect PrismA resin, the next generation of the MabSelect family. The resin is a new bead and a new ligand. It is designed to resolve bottlenecks in production and to have exceptional alkaline stability that allows for more stringent cleaning (enabling the use of 1M NaOH) and better control of bioburden.
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Thirty Years of Monoclonal Antibodies and Protein A: A Retrospective
Geoff Hale, managing director at BioArchitech Ltd, provides an overview of the development of the first monoclonal antibodies (MAbs), including how researchers improved with scale-up, purification, and quality control. These Campath antibodies were used to treat a number of diseases, including non-Hodgkin’s lymphoma and leukemia, and approved in 2001. Hale discusses the growth in MAb approvals and how MAb purification technologies have improved over the past 30+ years.
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A Discussion Regarding the Productivity in Downstream Operations
BioProcess International publisher Brian Caine and Jonathan Royce, global business leader for chromatography at GE Healthcare discuss purification challenges for biomanufacturers and the role of protein A in purification efficiency. They focus on bioburden risk and introduce the new MabSelect PrismA resin to help manufacturers produce more product with existing platforms, reduce cost, and decrease process timelines.
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