Monoclonal Antibody Early Development And Critical Considerations For Commercialization Success

Therapeutic mAbs are the output of complex biological processes. The production of a mAb requires a focus on both upstream and downstream procedures – the upstream process involves creating the ideal cellular “factory” and includes cell line development, clone selection, media optimization, growth and scale-up from bench to bioreactor volumes, and finally, the harvest and collection of the cells. The goal of the upstream process is to leverage the cells’ ability to produce the desired functional mAb with maximum output in minimum time. The downstream process then serves to isolate and purify the desired mAb from the cell’s environment with maximum purity and minimum loss.

The entire process is supported by quality control steps, automation technology, and analytical methods to ensure reproducible output and biological activity from run to run and as scale increases. The production of mAbs relies on many material inputs, instrumentation, procedural steps, and technical decisions. Read about a supplier that offers an expansive portfolio along the necessary continuum of bioprocessing, from media to mixers, cell lines to centrifuges, resins to refrigerators, and much more.