How to Avoid Common Pitfalls In Monoclonal Antibody Production and Application

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 [...]

By |2019-08-28T14:49:48-04:00August 28th, 2019|Manufacturing|0 Comments

How CMOs Are Meeting Unique Considerations in Fill-Finish Manufacturing of Biologics

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 [...]

By |2019-08-25T16:25:28-04:00August 25th, 2019|Manufacturing|0 Comments

Key Considerations For Current Good Manufacturing Practices (cGMP) in Biologics

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 [...]

By |2019-08-14T19:03:24-04:00August 14th, 2019|Research & Development|0 Comments
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