CMC

CMC stands for Chemistry, Manufacturing, and Control, encompassing all processes related to process development, quality management, and production from clinical samples to commercial pharmaceutical products. Even if a drug possesses therapeutic potential, it must meet specified standards and be consistently produced as a pharmaceutical product of uniform quality to successfully pass through clinical and regulatory phases and be distributed in the market.

To achieve this, the manufacturing process involves designing experimentally verified manufacturing methods that assure quality, determining the structure of Active Pharmaceutical Ingredients (APIs), establishing validated analytical methods, confirming impurities, and conducting stability tests. CMC is a critical domain that undertakes these steps to guarantee the quality and consistency of pharmaceutical products, making it an essential process for the commercialization of drugs.

The most commonly used methods for exosome purification include ultracentrifugation, density gradient centrifugation, tangential flow filtration, ion exchange chromatography, polymer-based precipitation, immunoaffinity isolation, and exosome purification kits. In the exosome industry, ultracentrifugation, tangential flow filtration, and ion exchange chromatography are generally the most common methods for exosome purification.