Our chemical development team, comprised of more than 150 scientists in four countries, exceeds expectations on even the most challenging projects. Working in state-of-the-art laboratories equipped with the latest process and analytical instrumentation, we efficiently conduct route scouting, rapid process development, optimization of reaction conditions for scale-up of materials for preclinical trials or large-scale manufacturing non-GMP and GMP.
With support from our expert team of analysts, chemical engineers and QA professionals, we rapidly and efficiently develop scalable manufacturing processes to meet any need, including development of high-potency APIs and DEA-licensed controlled substances.
Our complete suite of capabilities includes:
- Custom synthesis
- Process safety assessment
- Scale-up capabilities for GMP and non GMP purposes
- Route evaluation and development of new synthetic routes for target molecules
- Optimization of reaction conditions to reduce cost and maximize throughput by classical methods or statistical design of experiments
- Development of reliable methods for in-process testing and analysis of intermediates and APIs
- Development of robust crystallization procedures for intermediates and final products
- Salt selection and polymorph screening
- Ability to perform work under cryogenic conditions (-78 °C) or high pressures (> 100 psi)
- Preparation of APIs for nonclinical safety studies under GLP conditions
- Rapid screening of reaction conditions using parallel equipment
- Critical process parameter assessment
- Development of continuous flow processes
- Development of biotechnology processes, e.g., biocatalyst, fermentation capabilities and enzymatic reactions