Perspective On Next Generation Harvest Techniques

The class of monoclonal antibody (mAb) therapeutics has grown considerably in the last two decades and now makes up a significant portion of the biotherapeutics market. With more than 70 monoclonal antibody drugs on the market, and 33 of those drugs launched between 2014 and 2017, pharmaceutical manufacturing operations continue to adjust to the new demand, particularly around the processes of harvest, clarification, and purification of mAbs. Briefly, the primary goals for harvest and clarification operations are to remove cells and cell debris from mammalian cell culture, and further purify and clarify the resulting product in order to capture the mAbs via chromatography downstream. Traditionally, various technologies are used for these processes, such as centrifugation, microfiltration, depth filtration, and flocculants. However, new cell culture techniques, increased demand for monoclonal therapeutics, and a convergence of other factors in biopharmaceutical manufacturing has prompted the need for novel harvest and clarification techniques and technologies to increase the efficiency of the upstream and downstream processes for mAb production.

Academic and industry leaders in biopharmaceutical manufacturing participated in a new and unique thought leadership forum, the Frost & Sullivan Virtual Think Tank series. This forum brought together leading minds in manufacturing to discuss challenges, strategies, techniques, and barriers to new technology implementation in monoclonal antibody harvesting.