Custom Research & Manufacturing Services (CRAMS)
At SreeGana Pharma' facilities, highly skilled chemists routinely carry out syntheses of complex intermediates and final products With/without technology transfer; starts with process development/optimization and approval of lab sample, followed by commercial validation campaign, regulatory filing and approval and then the long-term commercial supply.
- Route of Synthesis (ROS)/Process Development.
- Route/ Process Optimization.
- Scale-up of established processes.
- Identification of alternate viable synthetic methods.
- Scale up synthesis of gram/ kilogram quantities of intermediates, building blocks and Scaffolds.
- Impurities – identification, characterization and synthesis.
For Target molecule without chemistry information
Optimization (1-2 weeks) based on
- Retro-synthetic analysis
- Literature search
- Raw material availability
- Capabilities of chemistry and facilities
- Raw material cost
- Paper costing
Proof of concept phase
- Pilot experiments (2-4 weeks)
- Molecule identification and characterization
Optimization phase (2-3 weeks)
- Process optimization
- process variation
- Critical parameters
- In-process control parameters
- Specification settings
- safety evaluation.
Scale-up phase (4-6 weeks)
- Raw material procurement
- Facility identification
- Batch record writing
- Scale-up implementation
- Dispatch of products
- Campaign report writing
Note: This timeline is considering 4-6 steps synthetic process. The timeline may vary if the special raw material is required with respect to scale-up.
For Target molecule with small scale process given
Raw material availability (one week)
- Capabilities of chemistry and facilities
- Raw material cost
- Paper costing
Optimization phase (2-4 weeks)
- Process optimization
- process variation
- Critical parameters
- In-process control parameters
- Specification settings
- safety evaluation
Scale-up phase (4-6 weeks)
- Raw material procurement
- Facility identification
- Batch record writing
- Scale-up implementation
- Dispatch of products
- Campaign report writing
Note: This timeline is considering 4-6 steps synthetic process. The timeline may vary if the special raw material is required.