Main Factors Affecting Industrialized Production of Solid Phase Peptide Synthesis Raw Materials

Quality Standards

At present, the raw excipients used in the production of solid phase peptide synthesis raw materials are mostly produced in China. The whole East Asia region is also the main region of raw excipients supply for solid-phase synthetic polypeptide raw materials in the world. When choosing raw materials and accessories, we should consider the quality, price, process matching and other aspects. The extreme value of a single parameter is often confirmed to be not the optimal choice.

In terms of the quality of solid phase peptide synthesis raw materials, we usually focus on purity, content, solvent residue and other detection items and pursue high standards. If necessary, other methods such as double-HPLC environmental detection or ion detection will also be introduced. For the same product, Euro-American Pharmacopoeia has higher requirements on residual solvents, burning residues and impurities than Chinese Pharmacopoeia.

Customers in European and American regulatory markets will pay more attention to some quality standards besides COA, such as biological activity, spatial structure, in-depth study of impurities, etc. This is based on the effect of preparation to evaluate the quality of APIs. In these aspects, Chinese enterprises need to keep the pace of them and strive for excellence to produce high-quality products in line with the international market demand.

Production Layout and Technological Exploration

The general process of solid phase peptide synthesis raw materials is synthesis → peptide → purification → concentration → freeze-drying → packaging. The main factors affecting the yield of the process are the quality of raw materials and accessories, process formulation, reaction time, reaction conditions, purification route, concentration method, freeze-drying curve, etc. The process enlargement from R&D to pilot production to industrial production is the most important step in the manufacture of solid phase peptide synthesis raw materials. On the one hand, we can find clues from open patents or documents.

On the other hand, practice is more important. Capacity enlargement is a complex multivariable model influenced by many factors. We should not only pay attention to the yield of a section, but also consider it as a whole.