About Cambridge Major Laboratories

Cambridge Major Laboratories, Inc. (CML) is a leading global chemistry outsourcing partner to the pharmaceutical and biotechnology industries. Cambridge Major produces pharmaceutical intermediates and Active Pharmaceutical Ingredients (API), from early preclinical development to commercial manufacture.

Company Description

As a leader in advanced chemistry services, Cambridge Major boasts an impeccable reputation for delivering some of the most challenging projects, while meeting the tightest timelines. Cambridge Major’s reach is truly global. Operating three facilities in the U.S. and Europe, CML is organized by five key integrated Centers of Excellence; Process chemistry, API Manufacturing, Analytical Services, Solid State Chemistry and Quality Assurance.

PROCESS CHEMISTRY

Custom Synthesis 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. This 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

Route Scouting

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.

Resources

PROCESS CHEMISTRY

From Discovery through commercial manufacture of active pharmaceutical ingredients – We Deliver

5 Centers of Excellence

Cambridge Major is organized along five key integrated Centers of Excellence, providing our clients with end-to-end solutions.

Request a Quote

Interested in having Cambridge Major quote on an upcoming project? Tell us more about your project goals and a member of our team will be in touch to discuss a potential partnership.