Process Chemistry and Chemical Development
Process Chemistry is one of the core competencies of Anthem .The Chemical development team has nearly 70 scientists, experienced in advancing lead molecules from bench to commercial scale production. Anthem is an ideal partner for rapid development, to produce drug substances for pre-clinical trials and to establish robust manufacturing processes. In past six years, Anthem has developed commercial processes for about 60 molecules which include complex raw materials, registered starting materials and drug substances. The Chemical development team is well versed with generating all required data including process justification for regulatory filings.Philosophy and expertise:
A glimpse of our expertise is listed below
- Route scouting and feasibility study
- Establishment of design- enhanced QbD(Quality by Design) approach (a systematic understanding of process parameters for pharmaceutical actives and intermediates)
- Investigative approaches to chemical development and optimisation using parallel synthesizer and jacketed glass reactor, focused on robustness
- Ability to examine process safety (by process hazard risk assessment using DSC, RCe1etc.)
- Chemical engineering concepts, particularly mixing, heat transfer and process control are studied during the course of development
- Establishment of in-process controls
- Development of processes which are scalable, safe and environment friendly
- Process optimization focusing on optimum reaction conditions and reagent quantities, minimum cycle time, maximum concentrations and telescoping of steps
- Hold time studies, establishment of parameter boundaries and challenge tests
- Study and determination of root cause of impurity formation and fate of impurities
- Analytical development in parallel
- Separation science expertise for isolation and characterization of impurities and preparation of impurity standards
- Tech transfer and process justification documentation
- IND/DMF support