Small Molecule API and Intermediates CDMO Services
Ⅰ Process Route Design and Scouting
? Design and explore a new route of synthesis.
? Develop a route of synthesis with a benchmark of 2~3 steps/week/person for route scouting.
? Assess whether the existing routes and related steps meet the requirements of amplification, cost, safety, and quality control.
? The principle of stepwise amplification process verification is adopted to ensure the stability of the process.
Ⅱ Process Development and Optimization
? According to the different stages of customer projects, our experienced team will customize suitable process development strategies for customers.
? Optimize process to improve robustness and output while reducing cost.
? Perform salt screening, polymorph screening, polymorph characterization, salt selection and process development.
? Apply Quality by Design (QbD) principles for process development.
Ⅲ Quality Studies
? Implement comprehensive quality research according to customer's quality requirements to ensure high quality and stability.
? Establishment of impurity control strategy with specification justification.
? QRA, DoE and QbD study support.
CMC BUSINESS
? Candidate drug process development.
? System quality research.
? Application batch and clinical batch sample preparation.
? Stability investigation.
? IND data collation.
Ⅰ Process Route Design and Scouting
? Design and explore a new route of synthesis.
? Develop a route of synthesis with a benchmark of 2~3 steps/week/person for route scouting.
? Assess whether the existing routes and related steps meet the requirements of amplification, cost, safety, and quality control.
? The principle of stepwise amplification process verification is adopted to ensure the stability of the process.
Ⅱ Process Development and Optimization
? According to the different stages of customer projects, our experienced team will customize suitable process development strategies for customers.
? Optimize process to improve robustness and output while reducing cost.
? Perform salt screening, polymorph screening, polymorph characterization, salt selection and process development.
? Apply Quality by Design (QbD) principles for process development.
Ⅲ Quality Studies
? Implement comprehensive quality research according to customer's quality requirements to ensure high quality and stability.
? Establishment of impurity control strategy with specification justification.
? QRA, DoE and QbD study support.
CMC BUSINESS
? Candidate drug process development.
? System quality research.
? Application batch and clinical batch sample preparation.
? Stability investigation.
? IND data collation.