Austin, TX August 23, 2011 In their published article “Isolation and characterization of therapeutic antibody charge variants using cation exchange displacement chromatography,” Genentech scientists demonstrate the value of adding displacement chromatography to the mAb characterization toolbox and highlight the potential to significantly enhance information about complex biological therapeutics.
“MAb variants may form during any part of the antibody manufacturing process including production during cell culture, downstream recovery and product formulation.” (1) The identification and/or isolation of these variants is critical as any of them can potentially affect the efficacy and safety of the therapeutic.
Genentech scientists state that the utilization of displacement chromatography can facilitate significantly faster product characterization timelines. The throughput of displacement is approximately ten times faster than standard preparative techniques, which makes it ideal for isolating charge variants in vivostudies. The scientists furthermore demonstrate that in an analytical capacity, displacement chromatography can reveal the presence of trace variants.
“SACHEM displacers accelerate protein analysis and add value to any QbD program by providing knowledge about charge variants critical to the performance of the therapeutic, commented Dr. Patrick C. McAtee, Sr. Manager of Biotechnology Applications at SACHEM. “Our SBS™ displacer system addresses risk management and quality assurance concerns in bioprocessing and drug discovery programs.
SACHEM, Inc. is a global chemical science company with full commercial operations in the United States, the Netherlands (Zaltbommel), Japan and China. SACHEM has been a leading supplier of products used in developers, etchants, and cleaners for electronics applications. Our high purity expertise enables the design of novel formulation components to achieve complex selectivity goals. Based in Austin, Texas, SACHEM’s expanding worldwide operations include manufacturing and research facilities in North America, Europe and Asia with a global service network and presence spanning over 30 countries.
(1) Zhang, Taylor et al. Journal of Chromatography A Volume 1218, Issue 31, 5 August 2011, Pages 5079-5086
