Development of cell culture processes are labor intensive and time consuming. This presentation focuses on outlining a development approach using high-throughput bioreactor and analytic systems that generate growth, productivity and product quality data that match those seen with the classical systems. This approach offers the realistic possibility of decreasing the process development timeline and costs for investigational biopharmaceuticals to reach the clinic. We evaluated three technologies; (1) ambrTM miniaturized disposable bioreactors controlled by an automated workstation for cell culture experiments. (2) ForteBio's Octet® for rapid and accurate analysis of antibody concentrations. Octet utilizes biolayer interferometry based biosensors for antibody quantification. (3) The LabChip® separation system that utilizes reusable micro-fluidic chips for rapidly screening N-glycan, protein charge and molecular weight profiles. The case studies presented here will illustrate the use of these high-throughput systems to study effects of various process parameters on cell growth, productivity and critical product quality attributes. The presentation also highlights a platform where the effect of process parameters on various product quality attributes are studied during the early phases of cell culture process development as opposed to the conventional methodology of optimizing for increasing production levels only.

High throughput process development: Utilization of high-throughput bioreactors and high-throughput analytics for rapid and robust cell culture process development

249th National Meeting (2015)

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