The Role of CDMOs in the Biopharmaceutical Ecosystem

CDMOs play a major role in the biopharmaceutical landscape by significantly contributing to a healthy life and providing continuous support to the industry in producing biopharmaceuticals for more diseases.

FREMONT, CA:Biopharmaceutical industries have advanced significantly with the continuous development of novel biopharmaceuticals and the most sold drugs. Contract development and manufacturing organisations (CDMOs) have emerged as a result of the increased demand for biopharmaceuticals.. It is entrusted with the development and manufacturing of production processes for pharmaceutical companies. Biopharmaceutical drugs, or biologics, are drugs manufactured using biotechnology. They are complex molecules, such as proteins or cells, used as medicinal ingredients. Protein therapeutics have dramatically changed with the advent of antibody drugs dominating the sales of new medicines in the pharmaceutical industry, resulting in a paradigm shift.

Despite significant progress in the biopharmaceutical industry, the contract manufacturing and development organisation (CDMO) that develops and manufactures drug substances under contract with pharmaceutical companies has expanded dramatically. Along with the continuous development of antibody drugs, various new biologics have emerged, expanding the biopharmaceutics CDMO market.

In the semiconductor industry, manufacturing technology has been standardised with the development of manufacturing techniques, making it possible to outsource semiconductor production. Therefore, fabless companies have increased their collaboration with foundries. Additionally, semiconductor manufacturing technology has advanced significantly with microfabrication technology, posing difficulties to create a product only by purchasing equipment.

Foundries have improved manufacturing technology through the combination of complicated processes and operating know-how. In the biopharmaceutical industry, manufacturing biologics, particularly antibody drugs, has been well-standardised. This standardisation has simplified the process of outsourcing the manufacture of biopharmaceutical drugs to CDMOs. In this context, the further development of biopharmaceutical CDMOs will depend on the advancement of their manufacturing technologies.

The semiconductor industry’s foundries have established a position in which semiconductor manufacturing technology is equal to or better than the IDM by acquiring novel technology and accumulating proven track records in the manufacture of semiconductor devices. Biopharmaceutical CDMOs can provide manufacturing technology of the same quality as pharmaceutical firms. To establish a similar position to the foundry in the semiconductor industry, biopharmaceutical CDMOs must acquire and develop distinctive manufacturing technologies.

In the biopharmaceutical industry, several technological innovations have occurred both in drug discovery and the manufacturing process. On the other hand, the horizontal division model in the pharmaceutical industry has become important; biopharmaceutical sectors focus more on drug discovery and development, and CDMOs concentrate more on process development and manufacturing. CDMOS must invest more in technological development and acquire new technology to maintain a competitive advantage. CDMOs will contribute significantly to a healthy life by providing continuous support to the biopharmaceutical industry in producing biopharmaceuticals for more diseases.