Successful production of therapeutic monoclonal antibodies and recombinant proteins is highly dependent on utilizing high-expressing cells, effective cell culture media and optimal upstream processes. Conventional batch and fed-batch modes of bio-production have been constrained by achievable cell density limits and their inability to maximize the expression of recombinant products. Recent process development efforts have focused on evaluating perfusion modes of bioreactor operation in order to increase efficiencies in either achievable cell densities, therapeutic product generation, or both. Implementation of perfusion into upstream process development laboratories necessitates evaluation of many practical factors, including bioreactor and bioreactor control capabilities, assembly and utilization of cell retention devices, and preparation and consumption control of cell culture media and supplements. This study will describe in detail how a 3L-scale bioreactor perfusion platform was evaluated and implemented. A review of scaling considerations and their impact on process economics will be presented. Lessons learned for perfusion implementation and best practice guidance will also be reviewed. In addition, preliminary results will be presented demonstrating the effectiveness of employing a novel cell culture media designed specifically for perfusion applications.

Best practice considerations for development and implementation of a mammalian cell culture perfusion process

255th National Meeting (2018)

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