One Step Sterile Harvesting of Mammalian Cell cultures in the lab

Bio-pharmaceuticals R&Ds are working with mammalian cell expression systems for developing mAbs and other therapeutic proteins. Scientists today are using increasingly smaller culture volumes grown in 10ml to 15ml micro bioreactor formats or even smaller volumes in 24 to 48 plate systems for clone and media optimization, cell line selection, small scale perfusion mimic and early process optimization. In these applications multiple cell harvests need to be clarified to remove cells and debris before the critical metabolite analysis/ chromatography steps. Conventional methods for clarification of such small volumes (few mL) are centrifugation followed by 0.2µm membrane filtration.

However centrifugation is a time consuming, cumbersome process and may also result in shearing of cells resulting in increased cell debris, cell organelles and intracellular proteins in the supernatant. The conventional syringe filter, although used for final filtration of the supernatant does not offer an efficient solution in terms of throughputs.’

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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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