Three Essential Considerations When Working With E. Coli Expression Systems
E. coli expression systems involve many variables but are one of the most common and efficient methods for protein expression. E. coli is by far the most popular protein expression platform. The days when pharmaceutical manufacturers had to refine large quantities of plant or animal tissues and fluids into the [...]
Optimizing the Lyophilization Cycle
The lyophilization cycle is a key component in the manufacturing process of many pharmaceutical products. Understanding lyophilization requires a basic understanding of sublimation—the process by which a solid transitions directly to a vapor or gaseous state without first passing through a liquid phase. Sublimation is part of the lyophilization cycle, [...]
The Quickest and Surest Path to Successful Clinical Trial Material Manufacturing
Clinical trials are an integral part of the drug development process, but successful clinical trials require materials that can be quickly and reliably produced in accordance with the dynamic demands of trial protocols. The manufacture of clinical trial material (CTM) often happens at smaller scale than other contract manufacturing operations, [...]
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 [...]
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 [...]
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 [...]