Natrix Separations Inc., a maker of innovative single-use chromatography products for the biopharmaceutical industry, announced today the introduction of its HD-Sb chemistry, a salt-tolerant, strong cation exchange (sulfonic acid) membrane augmented with HIC (t-butyl) groups. The HD-Sb chemistry offers high dynamic binding capacity, even at elevated salt concentrations. The Recon HD-Sb is the first in a line of HD-Sb products to be commercially available. The Recon HD-Sb is a disposable device designed for laboratory-scale purification of monoclonal antibodies and other…
Thursday, June 25, 2015 Daily Archives
e-Book: QbD Manufacturing Strategies — The CMC Strategy Forum Series, Part 2
The CMC Strategy Forums provide a venue for biopharmaceutical product discussion. They focus on relevant chemistry, manufacturing, and controls (CMC) issues throughout the life cycle of a therapeutic and thereby foster collaborative technical and regulatory interaction. Forum chairs share information with regulatory agencies to help them merge good scientific and regulatory practices. Outcomes of the forum meetings are published in BioProcess International and on the CASSS website. This process is meant to help ensure that biopharmaceutical products manufactured with advancing…
