CDMO Service
Patent research
Literature assessment
Proposals of potential synthesis routes
IP verification of proposed synthesis routes
Raw materials/intermediates market availability evaluation
Cost calculation
Laboratory verification of synthesis routes
Selection of synthesis route for optimization or based on IP assessment and cost calculation
Development of purification method
Preliminary analytical methods development
Optimization of chosen synthesis route- technology development
Development of analytical methods for product
Process laboratory validation
Validation of analytical methods
Transfer of analytical methods to Quality Control Laboratory
Cost calculation and IP assessment
Transfer to Manufactory
Scaling up in Pilot Plant
Scaling up in factory
Documenting in the batch production records, the facility log, or other documentation system
IP control and project confidentiality.
Meeting customer expectations
DongjianPharma brings many years of experience in the Small Molecule （Including intermediates）development and manufacturing market, where we have considerable experience with a repertoire of chemical reactions and transformations, including but not limited to:
Chemical reactions and transformations
>> Hydrogenations
>> Oxidations
>> Cryogenics
>> Friedal-Crafts
>> Organometallics
>> Amination
>> Cyanation
>> Carbonylation
>> Diels-Alder
>> Acylation
>> Phosphorylation
>> Bio-Catalysis
>> Chiral Synthesis
>> Halogenation reaction
>>Being active Project Team Member
>>Reliability
>>Adequate experience and resource availability
>>Equipped facility
>>ICH guidelines Q11 (Development and Manufacture of Drug Substances) and Q9 (Quality Risk Management) compliance
>>Good Laboratory Practice (GLP)
>>Good Manufacturing Practice (GMP)