Rapid Development and Scale-Up Through Strategic Partnership: Case Study of an Integrated Approach to Cell-Line and Process Development for Therapeutic Antibodies
The biosimilar development paradigm also demands significantly more bioanalytical analysis during initial cell-line and process development. Thus, a significant investment is being made to assure that molecules entering the pipeline are successful. It is therefore imperative to take an integrated approach to cell-line development and early stage screening and process development. This enables companies to make appropriate, timely decisions about pursuing therapeutic candidates for preclinical and clinical manufacturing.
A critical part of biopharmaceutical development is choosing the right cell line with the objective of confirming cell productivities, cell-line stability, and final-product quality. For a proof-of-concept program outlined herein, Cook Pharmica and Selexis were able to successfully develop a productive cell line, design an efficient process, and scale up a commercially available antibody. Selexis generated the high performance SURE CHO-M cell line that was used in Cook’s rapidly scalable development process at its state-of-the-art CGMP biologics manufacturing facility in Bloomington, IN. Current data from the program demonstrate comparability to the originator drug while achieving commercial-ready titers up to 4 g/L.
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