Tuesday, May 14, 2013

Can a Process be Too Productive?


Advances in monoclonal antibody (mAb) production have superseded the abilities of downstream processing systems. Current production systems generate much higher concentrations that cannot be handled by traditional separation processes. Whether it is ion-exchange columns or centrifugation systems, processing solutions with higher biomass has become a real challenge for the industry. At the same time, the growth in the biosimilar market is placing downward cost pressures on these downstream processes.

What do you think can be done to address this issue? Is enough progress being made with salt-tolerant and mixed-mode ion-exchange media? Will introduction of single-use systems be effective in reducing costs in general? What about the use of flocculation and precipitation? Membrane technology?

Beyond specific new technology solutions, what new strategies might be adopted to help overcome the challenges faced by mAb producers?

Share  your thoughts and ideas.
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Cynthia A. Challener, PhD
Editor
The Pharmaceutical Sciences, Manufacturing & Marketplace Report


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