Views: 19 Author: Site Editor Publish Time: 2019-05-28 Origin: Site
* According to literature research, evaluate whether existing routes or steps are suitable for scale-up in terms of material cost, safety, cycle, operability, etc.;
* Design and exploration of synthetic routes led by experienced chemists;
* Route exploration is usually carried out in parallel with multiple routes. The relevant process teams closely communicate and respond to information, adjust the route flexibly, and avoid missing any possible advantageous routes;
* Use LC-MS, GC-MS and nuclear magnetic resonance and other analysis and detection methods to quickly screen out the optimal route for subsequent process development;
* Quickly screen and optimize key steps through parallel reaction equipment and high-throughput screening platforms;
* Extensive application of new technology in process chemistry to achieve chemical transformation with difficult or harsh conditions;
* More than 20 years of rich experience in the use and production of hazardous chemicals to help route development progress.
Process development and optimization
* End-to-end process development and control strategy formulation;
* Support new drug IND and NDA registration and application;
* Process development and scale-up optimization of API to support GLP TOX research and clinical research;
* Process development characterized by robustness and cost reduction suitable for commercial production and supply;
* High-throughput screening and optimization of high-cost catalysts;
* Equipment risk assessment for project transfer (eg HAZOP analysis, equipment selection, process flow simulation and application).
Research on key process parameters
* Use failure mode and effects analysis (FMEA) method to analyze and study the target product quality profile (QTPP) and critical quality characteristics (CQA) to confirm the acceptable parameter range (PAR) and normal operating range (NOR) in the production process and critical process parameters (CPP). Complete quality risk analysis studies for each GMP step prior to process validation;
* In order to improve efficiency in practical research, professional statistical analysis software is used, DoE strategy is used for high-complexity process, and OVAT strategy is used for low-complexity process.
Registered starting material studies
* According to the guidelines of ICH and the actual requirements of drug administration departments in different countries, make corresponding suggestions on the definition of starting materials for registration;
* Help customers define suitable starting materials for registration according to the physical and chemical properties of the compound, the stability of the supply chain, and the complexity of the structure;
* Systematically study various impurities in registered starting materials, such as analogs, precursors, solvents and metal ions, to determine appropriate quality standards and impurity control strategies.
* According to the requirements in ICH-Q7, in the process of API production, through process verification, analyze personnel, equipment, materials, methods, process and operating procedures, and production environment, etc., to confirm that the products produced by the production system can meet the predetermined requirements. Products that meet the requirements of use and registration, and the process is stable and reliable, in line with the requirements of GMP;
* Relevant documents required for process verification: trial production plan and report, project introduction verification master plan, batch record template and corresponding procedures, workshop introduction production line risk assessment report, production line equipment suitability assessment report, stability test plan, analysis method verification report , Process Validation Scheme, Process Validation Report.