Austin, TX (PRWEB) May 27, 2010
Genentech presented a case study during the ‘Advances in Bioseparations’ section at the AICHE 2009 entitled, “Gram-Scale Isolation of MAb Charge Variants by Displacement Chromatography for Subcutaneous Animal PK Studies. The presentation reviewed the motivation for the study, citing the heterogeneity of MAb therapeutics, Quality by Design programs and the need for a quick process scale up for additional studies on the variants.
Dr. Hutchinson’s presentation showed how displacement chromatography allowed Genentech not only to identify previously undetected variant in MAb bulk, but also provided a scale up method for further characterization of the variant. The results of the study provided over 120 mg of the acidic, main and basic peaks for further rat PK studies. For the scale up, they used Source 15S from GE Healthcare, an AKTA and the displacer, Expell™ SP1.
Dr. Hutchinson discussed some of the challenges in the scale up as well including the aseptic collection of the fractions. They used endotoxin free buffers, created at AKTA cleaning protocol and collected the fractions in a biosafety cabinet.
Genentech has now looked at four different antibodies and the technique has worked on all of them.
SACHEM has ion-exchange displacers commercially available and is currently beta testing reversed phase displacers with several customers.
SACHEM, Inc. delivers highly pure, precise and innovative chemical solutions designed to solve the most demanding and challenging applications. For over 50 years SACHEM has provided chemical solutions and services to customers in key markets including electronics, biotechnology, starch modification, polymers, catalysts, pharmaceutical and agricultural chemicals. 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. For more information, please visit http://www.sacheminc.com.
# # #