Process Research
From custom synthesis design to process validation
Dr. Kevin Babiak, a 22-year veteran of Searle/Pfizer, heads Regis’ Process Development & Validation department, which handles everything from custom synthesis design through process validation.
Process development for research projects
Synthetic route modification through:
- Optimization of yields
- Elimination of hazardous reagents or intermediates
- Thermochemical profiling
- Elimination of costly unit operations
- Evaluation of safety concerns
- Evaluation of new synthetic routes
Validation
- Raw material vendor qualification
- Identification of impurity profiles for raw materials and intermediates in the commercial process
- Fate of impurities analyses
- Evaluation of chemical processes for environmental health and safety issues
- Identification of site specific needs for processing equipment including scaleup issues
- Determination of acceptable and failure limits to establish Critical Process Parameters
- Stability data for intermediates and final API
- Identification of appropriate storage conditions
- Validation documentation