GE Healthcare Launches Four New Affinity Chromatography Media for Production of Antibody Fragments and other Biopharmaceuticals

GE Healthcare has launched four new custom-designed BioProcess affinity chromatography media for industrial-scale purifications of various biopharmaceuticals, including antibodies, antibody fragments and Adeno Associated Virus (AAV). The new media have been developed as part of GE Healthcare’s Custom-Design Media program and enable the rapid one-step purification of biopharmaceuticals with both high purity and high yield.

New custom media include: KappaSelect for antibody fragments with kappa light chain; IgSelect for human IgG; AVB Sepharose High Performance for AAV; and VIIISelect for Factor VIII production. The media have all been designed with the robustness necessary for use in bioprocessing, including high chemical stability when using typical CIP (Clean-In-Practice) solutions, and a rigid agarose base matrix enabling both a high flow rate and the processing of large sample volumes, resulting in increased throughput.

The new media are based on the use of immobilized single chain antibody fragments as chromatography ligands, which have been tailored for specific separations in collaboration with BAC B.V.. BAC develops and produces antibody fragments for use in the manufacture of biopharmaceuticals. GE Healthcare’s Custom-Design Media group then uses these antibody fragments to develop chromatography resins. The facility is available for manufacturers to request additional custom media for specific purification tasks not yet catered for.

“Until now there has been little use of protein-based affinity resins outside the Protein A field due to the lack of robust technical solutions,” said Nigel Darby, General Manager, Biotechnologies, at GE Healthcare. “The collaboration with BAC has been extremely successful, providing an important tool in allowing us to develop customized affinity resins for our biopharmaceutical manufacturing customers, helping them to reduce costs and increase throughput whilst maintaining high yields and product authenticity. Custom Design Media is an important part of our Bioprocess offering, enabling us to support customers with new products for a wide a range of applications.”

Working closely with its customers, the Custom Design Media program (CDM) provides unique chromatography solutions that help optimize their specific bioprocessing applications. It is part of GE Healthcare’s portfolio of advanced technologies that support the philosophy of lean manufacturing and operational excellence in downstream processing by bringing new levels of simplicity, efficiency and economy - resulting in shorter time to market, increased output and reduced costs.

The products also include standard BioProcess™ chromatography media, available in various formats; AxiChrom columns, from pilot to production scale; ReadyToProcess™ platform of ready-to-use solutions for upstream and downstream bioprocessing; and PreDictor™ 96-well filter plates for high throughput process development.