The Economic Impact of Disposable Chromatography for Clinical Manufacturing
The landscape for biological manufacturing is changing. With market supply trending towards smaller annual production (less than 500 kg per year for antibodies), manufacturers are standardizing on single-use bioreactors at 2000L or smaller for upstream production, and striving towards more flexible multi-product manufacturing facilities. What is missing are 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 a typical Phase I manufacturing campaign, 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; in many cases the chromatography media and even the columns are discarded or retired. In addition, there are significant costs associated with setup, packing, packing validation, cleaning, and storage of a chromatographic column.
Natrix Separations is developing a platform of "plug and play" single-use-per-batch pre-packed chromatography devices and columns, offered as a pre-validated ready-to-use purification solution.
The webinar will describe Natrix’ hydrogel membrane technology, and show examples of applications for production of monoclonal antibodies. The financial impact of disposable downstream processing will be discussed.
To learn more about disposable downstream processing register for our webinar now.
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. He is the inventor of record on several U.S. patents, and is co-author of 18 peer-reviewed publications.
Over the past 15 years, Dr. Stout established himself as a downstream process and technology leader in the biopharmaceutical industry. His recent positions include Director of Process Science & Engineering at ImmunoGen; Associate Director of Process Development at Shire HGT; Director, Purification Sciences at Amgen; Group Leader of Purification Process Sciences at the Abbott Bioresearch Center; as well as process development positions at Medarex and Alexion.
