Inventory of the characteristics of pharmaceutical intermediates
The various products between the preparation of raw materials are pharmaceutical intermediates, and the synthesis of pharmaceuticals has a strong dependence on intermediates. Pharmaceutical intermediates are important raw materials for the production of APIs, which belong to the category of chemical products, and the production plants do not need GMP certification. And its production has certain particularities, and it is necessary to strictly follow the relevant requirements of GMP in terms of factory site selection, layout planning and factory building design. Different from the general chemical production process, the production process of pharmaceutical intermediates has the characteristics of miniaturization, single-batch batching and multi-function.
1. Miniaturization
The production of pharmaceutical intermediates has the characteristics of miniaturization. The characteristics of miniaturization are small reaction kettles, few raw materials and precise requirements, especially the liquid materials fed during the reaction process, which require a small amount and need to be controlled. For example, the common hydrogenation reaction process in the production of pharmaceutical intermediates is a small-scale batch reaction, mainly including the feeding process, replacement process, reaction process, post-reaction pressure relief process and discharge process. Hydrogen, solid materials and liquid materials are all hydrogenation reaction process materials. The general process is to add solid and liquid materials first, and then add hydrogen to react under a certain pressure. During the feeding process, it is necessary to treat solids and The addition of liquid materials is controlled, which is also a fine chemical process.
At present, large pharmaceutical companies are more focused on improving their core competitiveness, focusing on drug research and development and sales. In order to shorten the cycle of new drug research and development and reduce the cost of new drug research and development, they often outsource custom production of intermediates, and some companies provide intermediate custom synthesis services . Medicilon provides custom synthesis services for intermediates, and can synthesize reference compounds, intermediates, candidate drugs, impurities, metabolites and other small molecule chemical substances for customers, and the scale can range from milligrams to kilograms (including GMP quality). Its teams are proficient in new route design and route optimization, with their proficient problem-solving skills and high project success rate.
2. Single batch batching
The general chemical production process is mostly continuous production. The difference is that the production process of pharmaceutical intermediates is mostly single-batch intermittent, usually frequent single-batch production, requiring repeated pre-treatment and post-treatment, and These processes need to meet the requirements of "Good Manufacturing Practice for Drugs". In a continuous process, raw materials are continuously passed through a set of specialized equipment, each equipment is in steady state operation and only performs a specific processing task, and the product has been output in a continuous flow. The batch production refers to the processing of raw materials according to the specified processing sequence and operating conditions, and the output of products in a limited amount. Batch processes are dynamic in nature, with operating conditions and product quality changing over time.
3. Multifunctional
Reactors in the production of pharmaceutical intermediates usually require multi-step reactions or multiple processes, requiring different temperature control or pressure control at different stages. In order to complete the precise control of these processes, it is necessary to consider the characteristics of large-scale adjustment when designing the control scheme and selecting the instrument type.