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.