St. Louis, MO – The combined AAIPharma Services Corp. and Cambridge Major Laboratories, Inc. (AAI/CML), a provider of custom pharmaceutical manufacturing and development services, plans to relocate its St. Louis analytical testing facility to the city’s Cortex Innovation Center.
AAI/CML performs analytical testing for manufacturers’ new drug entities, generic drugs, animal health products, medicated consumer health products, chemicals and biopharmaceuticals.
The new facility is in response to a growing trend in pharmaceutical and biotechnology to outsource analytical testing, according to the company, which plans to invest some $10.7 million in the move.
With new equipment added to existing services, the facility is expected to offer new testing capabilities that meet changing regulatory and industry requirements, such as glass and plastic containers testing for pharmaceutical use, elemental impurities, disinfectant qualification, and efficacy studies.
“This expansion comes at a critical time in our company’s growth,” Stephan Kutzer, CEO, president and chairman of AAI/CM, said, calling analytical testing an “instrumental pillar” of the company.
The structural completion is expected in Q4 and transition from the existing location will take place early next year. A new FDA registration number will be issued to the facility, which will be located at 4260 Forest Park Parkway.
The plan is to notify clients in advance if particular studies will be relocated, according to the company, which added that concurrent operations will take place during the transition to assure continuity of testing commitments. In addition, company facilities in Edison, NJ and Wilmington, NC can offer support if necessary.
“This is yet another truly global bioscience company choosing Missouri for its strategic growth,” Mike Downing, director of the Missouri Department of Economic Development, said. “As the Cortex Innovation community grows, it continues to gain that much more gravity to attract further investment and job creation.”
The new facility will add 30 jobs over the next five years, bringing the full-time company head count to roughly 110 locally, according to the development department.
The Cortex Innovation Center area houses more than 160 companies and serves as a hub for technology, garnering $350 million in investment and generating 2,500 technology-related jobs since its inception in 2002, the department reported.
The current St. Louis facility specializes in chemical and microbiological analytical testing, including raw material testing, drug product release, stability, and environmental monitoring for both sterile and non-sterile drugs.
AAIPharma Services Corp. joined with Cambridge Major Laboratories, Inc. in 2013 to form an integrated custom development and manufacturing operation. With roughly 1,000 employees worldwide, the company now provides pharmaceutical and biotechnology services from seven sites in the U.S. and Europe.
(Sources: Missouri Department of Economic Development and AAIPharma Services Corp./Cambridge Major Laboratories, Inc.)