From synthesis route search to actual machine manufacturing support
AGC Pharma Chemicals offers process development services from early stage to commercialization, including route discovery, process optimization, method development, and scale-up.
In laboratory experiments, we quantitatively verify the robustness of the process with an eye on actual machine manufacturing with abundant experimental equipment. In addition, safety evaluations are conducted in parallel to achieve smooth scale-up and stable supply. The data obtained from the experiment is provided to customers in easy-to-understand reports and detailed explanations, contributing to speedy manufacturing start-up in drug development.
Service Overview
Considerations
Process Development
- Synthesis route proposal
- Synthesis route search
- Process development
- Risk Assessment (DSC)
- Risk assessment (heat flow)
Process Optimization
- Process optimization suitable for factory equipment
- Industrial raw material use test
Analytical method development
- Development of analytical methods (IPC)
- Identification of impurities
- Method validation (QA/QC)
Manufacturing Support
- Presence and support for the first production
- Optimization of reaction conditions and process improvement (Comprehensive study of improving reaction efficiency, reducing costs, improving safety, and reducing environmental impact)
- Evaluation of new suppliers
Deliverables for customers
Reports, documents
- Development report (CTD format is also available)
- Work order sample
- Youth test sample
- PoC sample
Data
- Process information
- Physical and Chemistry Dewei Data
- Chemical reaction characteristics
- Analysis method
- Analytical data
- Impurity list
- Safety test data
Strength Technologies
Fluorination reactions
The addition of fluorinated molecules in the production of active pharmaceutical ingredients, intermediates and starting materials is a very advanced specialty, and AGC Pharma Chemicals has a long history and experience with these compounds. We offer specialized technologies for fluorination and draw on our extensive experience in this field. AGC Pharma Chemicals offers fluorinated synthesis technologies such as
- Various types of fluorination reagents (HF, F2 gas, nucleophile/electrophilic fluorination reagents)
Innovative fluorination technology
- Nucleophilic fluorination
- Halogen exchange reaction
Fluorination of diazo compounds
- Electrophilic fluorination
- Electrolytic fluorination
- Utilization of abundant fluorine-containing structural units
Other Strength Technologies
- General organic reactions (grignard, lithioation, cross-coupling, amidination, Friedel-crafts)
- Redox reactions (TEMPO oxidation, hypochlorous acid oxidation, Vitride, silane reduction)
- Fluorination technology (halogenation, nucleophilic fluorination)
- Development of a new synthesis method using building blocks containing “”F”” (ClCHF2, tetrafluoroethylene derivatives, fluorine-containing gases)
- Dangerous reactions (cyanolatation, Cl2 gas)
- Versatile carboxylic acid intermediate production method (CO2 insertion reaction using Ni catalyst)
