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Development of an Efficient Manufacturing Process for Adenovirus

from Bio-Rad Life Sciences

"For more information, visit: Dr. Carsten Voß, Application Specialist, Process Chromatography, Bio-Rad Laboratories GmbH, discusses the challenges posed by large-scale downstream processing of viruses for clinical applications. These challenges mostly arise from the size and complexity of the virus. Here, viral purification results are presented for a two-column process using Nuvia™ Ion Exchange Resin and Nuvia™ cPrime™ Mixed-Mode Media that was developed for an efficient manufacturing process for a recombinant adenovirus. This adenovirus purification product is comparable to clinical-grade products, with high yield and very low levels of host-cell protein (HCP) and DNA contamination. This process is readily scalable, simple, rapid, and efficient and is thus well suited for the production of clinical-grade viral vectors. Nuvia™ Ion Exchange Resins are built on robust physical properties and optimized chemistries, delivering exceptional purification productivity over a range of conditions. Nuvia cPrime mixed-mode media is designed for versatile capture and high recovery across a wide range of salt concentrations and pH in process-scale purification processes for biotherapeutic applications. Advantages of Mixed-Mode Chromatography A variety of advantages of mixed-mode interactions have been observed beyond simply finer discrimination between product and impurities. They include: ■ Greater resolution compared to unimodal interactions ■ Improved yield and activity via advantageous use of charge-charge repulsion between ligand and protein ■ Large design space for protein binding ■ Minimal feed manipulation prior to binding ■ Mild operating conditions preserve activity Bio-Rad Process Separations offers a full range of chromatography solutions for biomolecule purifications. Visit us on the Web to learn more."

about 3 years ago

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