Recent data on viral clearance design space & polish purification for Clinical Manufacturing
Natrix Separations is developing a platform of "plug and play" single-use-per-batch pre-packed chromatography chemistries and columns, offered as a pre-validated ready-to-use purification solution.
The presentation will discuss the most recent developments towards productive single-use-per-batch purification tools for downstream processing.
Traditional or disposable columns (which are not single-use) require significant capital investment, validation, inventory management, and labour. For typical Phase I-III manufacturing campaigns, the cost of materials (pass-through costs for purification, hardware and resin) can be 30-40% of the cost of manufacturing the product at a CMO. After 1-3 batches, those materials would not be needed for several years, often resulting in the discarding or retirement of the chromatography media and/or columns.
Because disposable membrane chromatography columns can be right-sized for the batch size being processed, they can be fully consumed and discarded after each batch, resulting in economic efficiencies and enabling quick changeovers for flexible manufacturing.
The webinar will describe Natrix’s hydrogel membrane technology, and show examples of applications for production of monoclonal antibodies. Recent data on viral clearance design space, polish purification for impurity reduction, and a process productivity model with some economic impact analysis will be presented.
Presented by
James G. Stout, Ph.D.,
Vice President, Process Sciences, Natrix Separations, Inc.
Dr. Stout earned his Ph.D. in Chemistry at the University of Cincinnati, and was an NIH Post-Doctoral Fellow at the University of Cincinnati College of Medicine, Department of Pharmacology & Cell Biophysics. He holds a B.S. in Chemistry from Denison University. Prior to joining Natrix, Jim established himself as a downstream process and technology leader in the bioprocess industry, with prior Director level positions in Purification Process Development at ImmunoGen, Shire HGT, Amgen and Medarex and group leadership positions at Abbott and Alexion. He is the inventor of record on several U.S. patents, and is co-author of 18 peer-reviewed publications.
