AAI/CML provides analytical testing solutions for manufacturers' new drug entities, generic drugs, animal health products, medicated consumer health products, chemicals and biopharmaceuticals. Its analytical testing business is comprised of three centers in St. Louis, MO; Wilmington, NC; and Edison, NJ to serve its regional, national and global customers.
Its current St. Louis, MO facility employs approximately 80 full time staff and 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.
The new facility is a response to increased customer demand and the growing trend of analytical testing outsourcing within the pharmaceutical and biotechnology industries. It will house state-of-the-art equipment in addition to its existing service offerings, and will provide new testing capabilities to meet industry and changing regulatory requirements, such as glass and plastic containers testing for pharmaceutical use, elemental impurities, disinfectant qualification and efficacy studies.
The structural completion and build-out are due to be finished in the fourth quarter of 2016 and transition from the existing location will occur in the first quarter of 2017. AAI/CML's additional sites in Edison, NJ and Wilmington, NC will serve as testing support if appropriate.
Stability chambers at the new facility will be operational prior to removing this capability from the existing site so as not to interrupt any studies. Transfer of stability samples to the new facility will occur using temperature controlled equipment and will be monitored to ensure no deviations from specified conditions. The two facilities are within close proximity, with a travel time of less than 30 minutes from each other.
The new facility will have a new FDA registration number and clients will be notified in advance when their studies are planned to be relocated. AAI/CML 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.
"This expansion comes at a critical time in our company's growth," said Stephan Kutzer, chief executive officer, president and chairman, AAI/CML. "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."