As a world-leading CDMO company, BOC Sciences has accumulated many years of experience in process optimization. Our extensive expertise has helped customers optimize processes for thousands of compounds, with more than 100 of them reaching the commercialization stage. Our one-stop process development service covers all stages from synthesis route design, to pilot scale-up, to process optimization and validation. Our goal is to ensure that your project achieves technology transfer from the laboratory to the manufacturing plant, and finally a successful market. Our process optimization always follows the QbD concept, optimizing key process parameters to ensure consistent quality.
Our process optimization is based on the four principles of "improve quality; reduce cost; increase production capacity; reduce waste". The optimization measures are based on the improvement and innovation of the existing synthesis process. The main contents include reducing impurities; adjusting appearance and color; improving fluidity; replacing raw materials; changing reaction conditions (temperature, pH, feeding ratio, etc.); improving waste recycling rate, etc.
The focus of process optimization at different scale stages is different. In the pilot stage, the main goal is to ensure clinical trials, so the focus of optimization is to improve the reaction rate and yield. In the pilot test stage, it is more important to use a reasonable and stable process to ensure the successful transfer of technology. The optimization focus in this stage is to improve yield, reduce cost and ensure product quality. In the later stage of drug development, in the process of commercialization process optimization, it is necessary to clarify the quality control of starting materials and intermediates, study and control the physical properties of intermediates and APIs, and implement the application of the QbD concept throughout the process.
If you are interested in our process optimization service, please contact us immediately.