Early Development Overview
The R & D team of our company is composed of experienced scientific research experts from China and abroad. It is characterized by technological innovation and comprehensive technical ability. It has extensive and in-depth professional knowledge in the field of synthetic organic chemistry. It can independently design compound synthesis routes and has rich experience in dealing with complex compounds.
Our company has established good cooperation relations with scientific research institutions such as University of Illinois, Shanghai Institute of Organic Science, East China Normal University and Zhangjiang Public Service Platform, and has carried out various creative R & D cooperation.
Specializes in complex synthetic routes: ADC small molecules and highly active complex molecular drugs
Route design and screening
Salt form screening, crystal form research and crystal form process development
Study on crystal form process (small-scale process, kilogram-scale process)
Parameter optimization of route determination
Statistical and experimental design using quality by design (QbD) and multivariate data analysis
Quality Studies of Drug Substances and Intermediates
Study on the structure, source and control of impurities
Development and Validation of Analytical Procedures
Chiral drug synthesis
The chemical preparation methods of chiral drugs include chromatographic resolution, chemical resolution, induced crystallization resolution, resolution of drug enantiomers, chiral source synthesis, chiral catalysis, etc.
Crystal form
Screening of crystal form and salt form of compound, comprehensive characterization of dominant crystal form and development of crystallization process.
Separation technique
A variety of modes of preparative chromatographic separation technology, preparative liquid system is equipped with a full range of normal phase chromatography, reverse phase chromatography, chiral separation related to a variety of packing preparative chromatographic columns, can solve the technical problems often encountered in the separation and preparation of drug impurities.
The screening of emergency routes in the early stage of drug development or the screening of economic and effective routes for formal drug development project approval, through the evaluation of the technical feasibility, equipment availability, availability of raw materials and reagents, number of step reactions, patent protection of production route and impact on the environment of the selected route, the intermediate and API process route with stable and reliable development quality, low cost, safe process, environment and suitable for large-scale production is selected.
