Tag: Monoclonal antibodies

Over 200 therapeutic proteins have now received marketing approval worldwide, signaling a revolution in treating various medical conditions. Examples of protein therapies showcase the versatility of these molecules, from replacing deficient enzymes to precisely targeting cancer cells and modulating the immune system.

The global market for engineered protein drugs was estimated at over $387 billion in 2023, showcasing the immense and growing importance of these advanced treatments in modern healthcare. These powerful biological agents, which answer the question, "What does protein medicine do?" are used to treat a wide array of chronic diseases and conditions.

In biopharmaceutical manufacturing, Host Cell Proteins (HCPs) are a critical process-related impurity, with regulatory agencies often requiring levels below 100 parts per million (ppm) in the final drug product. Controlling these impurities is vital, as they can impact product stability, safety, and efficacy. This guide addresses effective strategies on how to reduce host cell proteins throughout the production process.