Austin, TX – December 11, 2009- Last month, 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 Designprograms 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^TM 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.