Specializing in process research expertise and practical technical advice in solving and avoiding problems in your API synthesis so resulting in your process being both robust and scaleable
Your Synthesis Issues
Is your process ready for scale-up?
Does your process have variable yields?
Are by-products and impurities causing havoc with intermediates or API?
Do you have poorly crystalline or unstable intermediates or API?
Does your process use costly starting materials or reagents?
Is the synthesis too long or too costly?
Does the process suffer from poor chiral purity control due to chemistry or resolution?
Do you have more than one synthesis route to choose from?
Are you looking for alternate ideas?
Do you need to prepare a technology transfer package?
Are you getting value from your CMO or CRO?
As a CMO, are the syntheses trabsfered to you from pharmaceutical companies unproven and problem intensive?
Specialties: Process Research Chemistry and Development
- Scale-up issues, problem solving, defining critical process parameters
- Reaction development and optimization
- Managing CRO process research
- Technology Transfers to CMOs
- Crystallization processes for API and critical intermediates
Process Research and Development
- Designing, evaluating, and managing synthetic route development to API and intermediates for large scale synthesis
- Long-term and short-term requirements, focusing on costs, scalability, robustness, and safety.
- Trouble shooting and problem solving scale-up issues
- Reaction optimization and improvement (yield, productivity, reagents, time cycles, exotherm control, kinetics, by-product formation, safety)
- Design of experiments (DoE) to evaluate and define operating conditions and CPPs
- Chiral chemistry, resolutions, racemization/resolution, dynamic resolutions, catalytic reactions
- Support of data analysis: HPLC, GC, LCMS, NMR, DSC, XRPD, TG, DVS, KF, titrations
- Crystallization development of polymorphs, solvates, hydrates, and salts of API and critical intermediates
- Flow Chemistry
Technology Transfer
- Writing and review of technical transfer and CMC documents, and patents
- Oversight and performance review of CMO operations
- Managing and review of CRO efforts for process development
- Writing and coordination of CMC chemistry and analytical data
Contract Laboratory Work
- Available to work in your laboratories for process development or CMC issues
Training Seminars and Lectures
- Aspects of process development
- Critical Process Parameters
- Developing reactions
- Crystallizations
- Solving scale-up issues
Seminars on real world process chemistry project experiences and strategies
