Cambridge Major Laboratories (CML) is a leading global chemistry outsourcing partner to the pharmaceutical and biotechnology industries. CML produces pharmaceutical intermediates and Active Pharmaceutical Ingredients (API), from early preclinical development to commercial manufacture. Operating from FDA-inspected facilities in the U.S. and Europe, CML is organized along five key integrated Centers of Excellence:
5 Centers of Excellence:
We understand 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 get the job done safely, efficiently, and on specification.
CML’s state of the art manufacturing facilities meet global regulatory requirements, GMP compliance standards, and are FDA inspected and approved. By leveraging the range of equipment in our manufacturing facilities, our pharmaceutical contract manufacturing services can support the drug discovery process through API synthesis for all stages of clinical trials. We conduct GMP manufacturing of APIs from grams to multi-ton quantities.
Solid State Chemistry
CML combines its leading position in process chemistry with solid state chemistry to provide clients the most optimal solutions ranging from polymorph screens to optimizing crystallization conditions along a synthetic pathway. In a world where development timelines are continually squeezed, there is an opportunity to optimize the drug substance development path by having the solid state chemist work in close collaboration with the process chemist at every step of the synthesis pathway.
CML provides a wide variety of analytical support services for development and manufacturing, consistent with the appropriate phase of drug development. Our method development philosophy is “fit for purpose,” meaning we will provide the appropriate level of development/validation to support your API based on where your compound is in the development cycle.
The Quality Assurance (QA) team at CML ensures that every stage of the development and manufacturing process meets customer and regulatory expectations. Whether the product is going into the domestic or international market, CML will ensure that all compliance and quality standards are met.
Regions where services are provided:
Cambridge Major serves clients across the United States, Europe, Asia and around the world.
W130 N10497 Washington Drive
Germantown, WI 53022