The commercial manufacturing success of monoclonal antibodies (MAbs) has become a touchstone of the biopharmaceutical industry. MAbs are so well established that they often are referred to as “traditional†biologics, and well-known MAb processing methods have become a model for processing of other “advanced†or “emerging†therapies. But MAb processing continues to advance as biomanufacturers seek ways to improve efficiencies, lower costs, and (most recently) increase sustainability of facilities. Drug makers are particularly interested in strategies for MAb process intensification.…
Author Archives: Michiel E. Ultee
New Directions in Bioprocess Development and Manufacturing
The biopharmaceutical industry continues to grow at a rapid pace. That growth is accelerating even more because of keen investor and research interests in cell and gene therapies. My focus below is on several key growth areas in the field, specifically aspects of development and biomanufacturing. This discussion builds on my 2018 column on top trends in bioprocessing (1). In that article, I identified five key trends that continue to resonate now: rapid development of high-productivity upstream processes advances in…
Production and Purification of a PER.C6-Expressed IgM Antibody Therapeutic
Immunoglobulin G (IgG) antibodies have been used to treat cancer for many years (1). Another class of antibodies—immunoglobulin M (IgM)—has been overlooked in spite of offering unique advantages that make them highly desirable as cancer therapeutics. Serving a valuable function in our innate immune system, IgM antibodies are the first to be secreted when an abnormal cell is present (2). These antibodies play a critical role in recognition and elimination of infectious particles (3,4), in removal of intracellular…