Although they make up the largest and most successful category of biopharmaceuticals so far, monoclonal antibodies (MAbs) suffer from certain disadvantages. Some companies are addressing those limitations by deconstructing MAb molecules to create new emergent therapeutics. These antibody derivatives include: antibody fusions and fragments, bispecifics, trifunctional antibodies, and more. This eBook combines market analysis from consultant David Orchard-Webb with technical discussion from BPI cofounder and senior technical editor Cheryl Scott. It also includes commentary from editorial advisor Michiel Ultee and…
Author Archives: David Orchard-Webb
Progress Toward Commercial Scale and Efficiency in Cell Therapy Bioprocessing
Regenerative medicine includes both cell and gene therapies. Currently 672 regenerative medicine companies operate around the world, and 20 products have been approved by the US Food and Drug Administration (FDA). Of 631 ongoing clinical trials by the end of 2015 (1), over 40% are in oncology, followed in prominence by cardiovascular and infectious diseases. Here I focus on gene and cell therapy bioprocessing in which the final products delivered to patients are cells. Cell therapies are either autologous (derived…