Scale up process
Once your innovative drug project pass the discovery to pre-clinic and clinic stage, our scale-up team will quickly discover the best synthesis pathway with lower cost, higher yield and etc to meet your rising need on the advanced intermediates of drug candidates and investigational drugs.
The optimization of synthesis process and production scale-up services of advanced pharmaceutical intermediates
Starting material customization
Synthesis technology study
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Route design and determination
- Process optimization Optimization of important process parameters
- Establish quality standards for raw materials, intermediates and finished products
- Establish center control standards
- Impurity spectrum study
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Impurity/standard sample preparation (or purchase) and standardization
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Preparation and standardization of advanced intermediates standard samples
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Preparation and standardization of raw materials and intermediates
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Impurity standard sample (prepare or purchase impurity; Structure confirmation and standardization should be carried out if necessary, and the impurity mass should be 10mg-500mg)
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1 batch of lab process is confirmed
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Safety assessment batch 1 batch
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2 batches of pilot scale production
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1 batch produced by GMP
Quality study
- Develop and optimize the analysis methods for material inspection, release and control analysis
Stability study
- The draft of material quality standard
- Analysis method development and optimization
- Material inspection and release
- Central control analysis
- Validation of analytical method
Reports and Information
- Process optimization report
- Pilot production report
- Method validation report
- Stability test report
- Expected starting time:
- Term of the contract:
- Other requirements
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