Effect of Sterilizing Filters on Process Economics in Bio-pharmaceuticals

Bio-pharmaceutical manufacturing is a complex, multistep process involving a very wide variety of process streams under different process conditions at different steps. These process streams include cell culture media, media additives, growth regulators in the upstream and post centrifuge cell harvest supernatants, post viral inactivation process intermediates, buffers, and high value product concentrates in the downstream. Filtration and purification of such a wide spectrum of process streams, to achieve different process objectives at each process step, is quite a challenge for the process owner. Also the increasingly competitive market conditions, due to the introduction of biosimilars, further escalates the demand for higher standards of filter performance, with respect to economy, safety, and impact on final product quality.

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