API Research and Development

• Evaluation and API route scouting for early phase or potential projects Process development and technology transfer for small molecule APIs in early phase development and optimization of chemical processes Kilo-lab and small scale production under ISO or cGMP standards Process optimization via simulation Analytical and testing services including identification of impurities and characterization of API products and intermediates

We provide cost-competitive manufacturing on an industrial scale by optimizing chemical processes, utilizing advanced PAT and minimizing unit operations, supported by specialized quality control and quality assurance expertise.

We focus on customer technology, regulatory and development API needs, to deliver:

• easibility studies which include: development of innovative processes and 2nd generation processes (1-3 months) Small scale quantities (10–100 kg, 3–10 chemical steps; APIs) (2-3 months) Process development production of launch quantities (100 kg –5 tons), full regulatory support, validated processes (APIs, HPAPIs) (3-6 months) Support of direct API technology transfers from clients to our industrial plants (1-3 months).

 

Development and Optimization of Chemical Processes

Our API R&D and manufacturing teams have experience in many types of advanced chemical synthesis techniques. We are always prepared to adopt and optimize your process or offer you many advanced techniques of our own. In either case, our team can provide you with successful development technologies for all of your chemical processing needs.