Anything But Chromatography?
April 1, 2008
In 2006 a new term was coined that is now all too familiar in the industry: downstream bottleneck. With observations of a slow cycle of downstream process improvements indicating potential solutions in the next five years, downstream processing is a very hot topic at conferences and in publications. Thus, the Recovery and Purification track will be highly focused on this pertinent and timely issue. Beyond discussing the bottleneck itself head-on in the opening sessions, the track will focus on alternatives to protein A purification and conventional chromatography, benefits of single-use technologies, optimization strategies, and enhanced downstream process development methods.
Joe Zhou, scientific director of process development at Amgen, will analyze single-use systems in downstream processing. He will look specifically at the use of single-use depth filtration, membrane chromatography, and nanometer filtration technology products for MAb processing. In an interview with BioProcess International, Zhou explained that in order implement single-use technology in the downstream processing steps, the cell culture processes must be optimized.
“The improvements for the cell culture part is removing whatever the impurity is — particulate, turbidity, or chalk level,” explained Zhou. “And also add a prewash step to the protein A, and remove turbidity, chopped DNA, or complex lipids. Then the output from protein A will be very clean already. That will not give you much challenge when you apply it to any disposable system of Q-membrane, or depth-filter, or the 20-nm filtration.”
Another new term is ABC, or “anything but chromatography.” This concept is central to efforts in the downstream processing sciences because the cost of chromatography columns greatly affect manufacturing costs as a whole. Zhou explained that with lowering stock prices at big biopharmaceutical companies, the downstream teams have to work harder while continuing to provide for product safety.