Chemical CRDMO Service

Jiangxi Chiyan has comprehensive research and development capabilities and equipment, including Medicinal chemistry, synthetic chemistry, process research and analysis support. Through our excellent and experienced team of chemists, with professional synthesis techniques and familiarity with various reaction types, we are able to provide customers with high-quality and efficient research services for various chemical molecule synthesis. We can convert small amount synthesis methods of compounds into several kilograms of process routes, optimize processes and costs, and ultimately achieve commercialization, Ensure the research and commercialization of the project are completed within very strict time constraints.

Medicinal Chemistry

Jiangxi Chiyan Cooperation has a team of nearly 100 pharmaceutical chemists, with well-known domestic and foreign large pharmaceutical companies and biotechnology companies in New Drug Research and development and cooperation experience. Under the leadership of internationally renowned and experienced leading personnel in pharmaceutical chemistry, Jiangxi Chiyan can provide its clients with value-added pharmaceutical chemistry R & D services covering a variety of targets and disease fields, from the discovery of active compounds, target validation, discovery of active compounds to Lead compound, and Lead compound optimization to discovery of preclinical drug candidates. Jiangxi Chiyan has successfully helped clients find multiple preclinical drug candidates in its drug R & D projects with clients. Jiangxi Chiyan Pharmaceutical Chemistry team can provide the following services to clients:

• Feasibility assessment of new drug targets

• High-throughput screening and structural design-based active compound discovery 

• Discovery of active compounds to lead compounds 

• Optimization of lead compounds to identification of preclinical drug candidates 

• Computer-aided drug design 

• Study on structure-activity relationship of compound molecules 

• Small molecule compound synthesis 

Synthesis of PROTAC molecules and ADC payloads, as well as lipids, glycolipids and phospholipids, etc. 

• Patent application 

With rich experience in pharmaceutical chemistry, we can efficiently promote the customer's drug research and development projects, promote the new drug process to enter the identification of drug candidates and clinical research of new drugs earlier, and help customers control the cost of new drug development.

Synthetic chemistry

Our team has professional training, strong chemical problem solving skills, and maintain close contact and interaction with the customer, timely communication to ensure the smooth progress of the project, and concerted efforts to achieve the project objectives specified by the customer. In FTE's service model, we design synthetic routes for our customers' target molecules, and complete the synthesis and delivery of compounds on time, in quantity and quality. These compounds include control compounds, metabolites, reagents, intermediates, molecular fragments, and impurities. Its scale can range from mg to kg (including GMP quality). Our team is well versed in new route design and route optimization, and with skilled problem solving skills and high project success rates, we are able to provide our clients with the following high-quality services: 

• Preparation of special reagents, intermediates and molecular fragments

• Preparation of APIs or related substances (ANDA)

• Impurity and metabolite synthesis design and preparation

• Analytical support

• Delivery of product technical documentation and analysis reports

• Synthesis of standards

• Synthesis of stable isotope internal targets

• Synthesis and resolution of multiple chiral compounds

• Synthesis of deuterated compounds

• High quality product preparation from mg grade to kg grade

Technical study

Our process department uses the existing resources, complete production equipment and the latest advanced production facilities to provide customers with high efficiency and maximum production capacity services, saving customers' time and costs, and producing reliable, cost-effective intermediates and API products for customers. We are committed to developing stable, low-cost processes suitable for mass production. Our R&D team has extensive experience in process optimization and the development of new, safe and environmentally friendly process routes. We provide our customers with the following process services:

• Screening of commercialization routes

• Develop and optimize commercial processes through Reaction Design (DoE) and Quality Design (QbD)

• Unit operation study and confirmation of key process parameters for each step

• Study of the structure, source and control of impurities

• Definition of the starting material of the process

Analytical chemistry

The analytical chemistry and purification separation team of Jiangxi Chiyan provides customers with high quality analysis and purification separation services. Our experts have extensive experience and problem-solving skills to enhance customer satisfaction. We mainly provide the following services:

Impurity analysis

• Separation of impurities from regulatory starting materials, intermediates, apis and pharmaceutical products using various technologies such as HPLC

• Complete 1D/2D NMR, LCMS, EA, HRMS, IR, UV and other data were collected to identify the structure of the isolated impurities

• Separation and structural identification of API's forced oxidative degradation Rapid determination of crude materials, intermediates, APIs and synthetic impurities using quantitative NMR (QNMR)

• Prepare professional application materials

Method development and methodology validation

• API method development and validation (according to requirements of Chinese Pharmacopoeia, US Pharmacopoeia, European Pharmacopoeia, ICH, etc., and other special requirements of customers)

• Residual solvent method development and validation (according to the requirements of Chinese Pharmacopoeia, US Pharmacopoeia, European Pharmacopoeia, ICH, etc.)

Conventional analytical instrument

• Chromatography: UPLC, HPLC, LC-MS, GC, IC, SFC analysis (including ELSD detection) 

• Solid state characterization analysis: Differential Scanning calorimeter (DSC), Thermogravimetric Analyzer (TGA), X-ray Powder Diffraction (XRPD), Particle size Analyzer (PSD), Polarized light microscopy

• Analytical identification: Nuclear magnetic resonance (NMR), Fourier Transform infrared spectroscopy (FT-IR)

• General test: Moisture meter (KF), Ultraviolet and Visible spectrum (UV-Vis), Polarimeter

• Routine physical and chemical tests (ROI, LOD, Cl-, SO42-, mp, HM, optical rotation, moisture determination, heavy metal residues, etc.)