Rapid Development and Scale-Up Through Strategic Partnership: Case Study of an Integrated Approach to Cell-Line and Process Development for Therapeutic Antibodies

Today, we feature an article from our partners at BioProcess International Magazine. This is an excerpt from the article Rapid Development and Scale-Up Through Strategic Partnership: Case Study of an Integrated Approach to Cell-Line and Process Development for Therapeutic Antibodies.

Rapid Development and Scale-Up Through Strategic Partnership: Case Study of an Integrated Approach to Cell-Line and Process Development for Therapeutic Antibodies

Over the past decade, monoclonal antibodies have become mainstream therapeutics for treating a broad range of conditions from autoimmune disorders to cancer. Part of this evolution is increasing time and cost pressure on biopharmaceutical companies to bring new drugs to market. Additionally, companies now routinely engineer and screen molecules for developability and manufacturability during discovery before selecting a final candidate molecule.

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.

Read the full article here.



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