10.15.19 -- Scale-Up Strategies For Retroviruses, Mabs, And More
Downstream Strategies To Meet Manufacturing Demands
Process-scale protein purification is an essential part of modern drug development. Biopharmaceuticals today include monoclonal antibodies, signaling proteins, fusion proteins, blood products, vaccines, viral vectors, enzymes and other biomolecules. Whether these biologics are produced by recombinant DNA technology or extracted from sources such as plasma, they need to be highly purified — and the purification process must satisfy a variety of regulations.
Antibody Purification In Flow-Through And Bind-Elute Modes
Mixed-mode chromatography resins offer a wide design space for difficult to purify proteins. Two case studies demonstrate the purification of an acidic and a basic antibody with a hydrophobic AEX mixed-mode resin through bind-elute and flow-through modes of purification. The results show improved process productivity and economy.
Purification of enveloped viruses and virus-like particles presents several challenges due to their large size and complexity. This study explains the importance of resin screening and the scale-up purification strategies of a retrovirus. The process employed a single AEX step and delivered final product purity and quality consistent with requirements for clinical trials.
CHT Ceramic Hydroxyapatite Media is an easy-to-use mixed-mode chromatography media. It is used for the purification of numerous types of biomolecules and is considered the gold standard for aggregate removal. This 15-minute webinar provides best practices and guidelines for successful CHT column packing.
The global biosimilars market is set for continued growth. Biosimilars are significantly cheaper than biologics due to the shorter development time and fewer associated costs. Non-affinity purification platforms are proposed to improve overall process economics and purification results.