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.

FACILITIES - U.S. DEVELOPMENT HEADQUARTERS

Cambridge Major Laboratories' US Development Headquarters is housed in a state-of-the-art 60,000 square foot GMP facility. The site has all of the capabilities required to provide API development and API manufacturing services from early pre-clinical to post-NDA commercial production. The facility has a wide range of technologies including plant scale hydrogenation and cryogenics (-90C).

General features of the US Development Facility are as follows:

4 Process R&D Laboratories (glassware to 50L)
5 GMP Kilo Lab Suites (glassware to 50L)
4 GMP Plant Process Areas (26 reactors from 50 gal to 500 gal)
3 Separate Analytical/QC Laboratories
3 HEPA Filtered Drying Suites
1 HEPA Filtered Packaging Suite
ICH Stability Chambers
GMP Storage/Warehousing Areas

The facility incorporates all of the latest technologies for HVAC and Process control. The HVAC systems are controlled by a Building Automation System (BAS) which monitors the temperature, pressures and humidity of the processing areas (labs and plant). Each processing area contains its own Air Handling Unit with once-through air.

Resources

Equipment List

ABOUT US

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