The foundation for success in manufacturing is an open dialog between research and manufacturing. From the initial project onboarding until final product manufacture is complete, our research scientists and manufacturing team communicate at key intervals during the developmental process. Phase appropriate development by QbD following ICH Guidelines ensures that the chemistry developed is readily scalable in a manufacturing environment and that critical process control parameters are identified.
Cambridge Major understands that maintaining a high ratio of Ph.D. scientists is essential to provide rapid and reliable chemistry services to support early preclinical quantities through full production at plant scale. Because our Ph.D. scientists follow the projects from the lab into the plant, we have the expertise to troubleshoot any possible issues that may arise during the scale up phase.
Whether you need a synthetic route completely developed, or can provide us a fully developed process, we’ll do whatever it takes to get the job done safely, efficiently, and on specification. Combine this with an obsessive focus on delivery and you’ll understand that we are the right choice for all your chemistry needs.
Process Chemistry Solutions
Cambridge Major’s reputation for providing solutions and expertise to solve our clients most difficult and challenging issues is unparalleled. Here are a few of the problems we solve daily for our clients:
- Low overall yield or high dilutions
- Difficult removal of metals to ICH limits
- Removal of dangerous or hazardous reagents or intermediates
- Difficulty eliminating chromatography from intermediates or API
- Difficulty crystallizing intermediates or API
Cambridge Major also provides comprehensive process research services aimed at scouting alternate routes to existing molecules. This can range from complete route development to targeted research on a single challenging step in a synthetic pathway.
Cambridge Major can perform process research with automated parallel experimentation, analogous to combinatorial chemistry in drug discovery. Cambridge Major has the resources to incorporate design of experiments (DOE) to set up modeling. Through DOE experiments, multiple variables are changed simultaneously to find the optimum process, as opposed to the more classical approach of changing one variable at a time (OVAT) and finding the best value for one parameter before moving on to the next.