Conference Dates

September 17-21, 2017

Abstract

Continuous manufacturing offers great potential for reducing costs in biopharmaceutical production through process intensification. However, adoption of new manufacturing methods and technologies is dependent on proof that the risk is worth the reward. Here Pall Life Science’s integrated, continuous downstream mAb platform is modeled in BioSolve Process. Supporting information is generated from a real, PD scale continuous platform. Perfusion and traditional fed batch cell culture processes are also modeled in both stainless steel and single-use forms. The cost associated with these three downstream strategies are compared across a range of bioreactor volumes, titers, and number of batches per year. This experimental design space is divided into clinical and commercial regimes that differ in resin reuse assumptions and correspond to mAb throughput ranges of 0.05 – 18 kg/year and 0.5 – 400 kg/year, respectively. The three downstream strategies continuous, traditional batch and single-use batch, are evaluated across the range of manufacturing scenarios for two metrics: cost of goods (CoGs) and net present cost (NPC). By breaking down the value of each platform to the cost contribution from clarification, purification, polishing, and final formulation, a detailed comparison can be achieved. The modeling exercise reveals that continuous and single use technologies facilitate reduced manufacturing costs in almost 80% of the scenarios evaluated. The continuous platform offers up to 60% savings in both CoGs per gram and NPC over batch manufacturing methods, with the best savings generally occurring at higher bioreactor titer and volume.

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