MAb Production in Stirred Tank Bioreactors with Disposable Bags The MAb example in section 12.6.3…

MAb Production in Stirred Tank Bioreactors with Disposable Bags The MAb example in section 12.6.3 analyzes a process for producing 1,544kg of purified MAb per year using four 20,000 liter stainless steel production bioreactors operating in staggered mode (out of phase) and feeding a single purification train. The product titer is 2 g/liter and the cycle time of each bioreactor is 2 weeks. In the last few years, new cell lines have become available (e.g., PER.C6 from Percivia) that can reach significantly higher product titers ( 20 g/liter). Deployment of such cell lines greatly

MAb Production in Stirred Tank Bioreactors with Disposable Bags The MAb example in section 12.6.3 analyzes a process for producing 1,544kg of purified MAb per year using four 20,000 liter stainless steel production bioreactors operating in staggered mode (out of phase) and feeding a single purification train. The product titer is 2 g/liter and the cycle time of each bioreactor is 2 weeks. In the last few years, new cell lines have become available (e.g., PER.C6 from Percivia) that can reach significantly higher product titers ( 20 g/liter). Deployment of such cell lines greatly reduces the volume of the upstream equipment and enables single-use systems to produce metric ton quantities of MAbs. Rocking and stirred tank bioreactors that utilize single-use (disposable) liners (bags) have become popular in the biopharmaceutical industry because they eliminate the need for cleaning and sterilization-in-place. Other advantages of such systems include increased processing flexibility and shorter validation, start-up, and commercialization times. Single-use bioreactors are available with working volume of up to 2,000 liters. Design a process using the new technologies described above which can produce 1,200kg of a therapeutic monoclonal antibody per year. Assume you make use of the PER.C6 cell line that can consistently reach 10 g/liter of product titer. For product purification, assume that you need two adsorptive chromatography steps (e.g., affinity and hydrophobic interaction) followed by a polishing ion exchange membrane adsorber that operates in flow-through mode (the product flows through the unit but certain DNA and other charged impurity molecules are retained by the membrane). Your analysis should include overall material and energy balances, equipment sizing, and estimation of capital and operating costs.

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