AAIPharma Services/Cambridge Major Laboratories (AAI/CML) said today it will spend at least $10.7 million to relocate its St. Louis, MO, analytical testing facility to the Cortex Innovation Center. AAI/CML said the new facility follows both increased demand from customers and greater use of analytical testing outsourcing within biopharma.
“This expansion comes at a critical time in our company's growth,” Stephan Kutzer, AAI/CML’s CEO, president and chairman, said in a statement. “Analytical testing is an instrumental pillar of our company and we are excited to provide our customers and the market with innovative testing solutions as part of our overall service offering including our other pillars in API, Drug Product, and Development Services.”
AAI/CML’s current St. Louis facility, at 6200 S. Lindbergh Blvd., 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. About 80 full-time staffers are based there.
The company said the new testing site will provide new testing capabilities to meet industry and regulatory requirements, such as glass and plastic containers testing for pharmaceutical use, elemental impurities, disinfectant qualification, and efficacy studies.
Structural completion and build-out for the new facility are expected to be finished in the fourth quarter of this year, with the transition from the existing location set to occur in the first quarter of 2017. AAI/CML said the new facility will be operational concurrently to ensure no interruption of customer commitments in testing during the transition period until the new site is fully operational.
AAI/CML said it will absorb the cost of method transfer exercises, re-verifications, or method suitabilities related to the site move, ensuring relevant regulatory requirements continue to be met. In early 2017, clients will be notified by AAI/CML with details of relocation activities and a new shipping address for sample submissions. Customers will be notified in advance when their studies are set to be relocated.
AAI/CML provides analytical testing solutions for manufacturers' new drug entities, generic drugs, animal health products, medicated consumer health products, chemicals, and biopharmaceuticals. The company’s analytical testing business consists of three centers of excellence—one each in St. Louis, Wilmington, NC, and Edison, NJ. The Edison and Wilmington sites will serve as testing support if appropriate.