Monoclonal antibody production is expensive and complex but produces highly specific antibodies which can target antigens extremely effectively. Antibodies attach to antigens at the antigens’ epitopes. The specificity of an antibody’s variable region is what determines its affinity for the epitope. Some antigens may be so chemically similar, however, that antibodies raised against one antigen [...]
In the last few years, monoclonal antibody (MAb) products have become some of the top-selling drugs in the world. In fact, the biologics market as a whole, which already accounts for more than 20 percent of drug sales worldwide, is growing at a rate of anywhere from 10 to 15 percent per year. This includes [...]
Nearly every industry in the world has “best practices” that should be followed in order to ensure safety, reliability, efficiency, and compliance. However, in regulated fields such as the production of biologics, these sorts of “best practices” also have more binding cousins called Current Good Manufacturing Practice (cGMP) regulations. These regulations are established and enforced [...]
