Generally, the industrial technical standards and characteristics of chemical synthesis in peptide drugs are relatively complicated, such as the technical requirements, the cost of drug development, investment risk, and so on. In brief, such industry owns the high input, high risk, and long-cycle features. Drug production is required to meet stringent technical standards, as well as the production equipment, technical process and some other demands.
Currently, the North America and Western Europe could be the leading countries in chemical and pharmaceutical fields, holding more advanced chemical synthesis progresses with a strong proprietary and certain technological advantages. However, on the other hand, the chemical synthesis of polypeptides requires rich attention because modern advance is still in its infancy, despite of decades of rapid development. It indicates a fact that having a wealth of drug patents and strong R&D capability could be the only way for further scientific research. Clearly, the industrial technical features for chemically synthesized peptide drugs are high efficiency, available parameters, as well as a wide range of purification reaction requirements. Required equipment for polypeptides production demand a higher cost than any other industries, which is due to the complex chemical process for synthesis of peptide drugs.
Through years of development, synthesized polypeptides industry has mastered the desired core technology on the production of varying peptide drugs and the technical level is in international advanced stage. There are a variety of applied technologies in synthesized polypeptides, including impurity control technology, hybrid solid-liquid phase peptide synthesis, polymer purification technology, multiple cyclic peptide synthesis, etc. These technologies have met the international quality standards, enabling to reach large-scale production level. As is seen, chemically synthesized polypeptide drugs are prescription drugs so that consumers must rely on the prescription. R&D and production of chemically polypeptide drugs usually use CRO and CMO mode because such drugs are in patent protection which don’t require self-substance and production workshop.
In addition to the details discussed above, this special industry has its regional or seasonal characteristics as well. Based on its mass indications ( in cancer, cardiovascular diseases, infectious diseases, immune system diseases, etc. ), chemically synthesized polypeptides possess a wide application of customers. The marketing demands are enabled to maintain steady growth, without a significant cyclical, regional and seasonal feature. Certainly, more efforts are still required for such industry.