AAI/CML To Invest $10.7 Million for New Analytical Testing Facility

AAIPharma Services Corp./Cambridge Major Laboratories, Inc. (AAI/CML), a provider of custom manufacturing and development services for the pharmaceutical and biotechnology industries, plans to invest at least $10.7 million to relocate i analytical testing facility in St. Louis, Missouri to the Cortex Innovation Center in St. Louis.

AAI/CML provides innovative 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 of excellence in St. Louis, Missouri; Wilmington, North Carolina; and Edison, New Jersey to serve its regional, national and global customers.

Its current St. Louis 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 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. 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's additional sites in Edison, New Jersey and Wilmington, North Carolina 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. Clients will be notified prior to shipment of stability samples.

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. In early 2017, clients will be notified by AAI/CML with details of relocation activities and a new shipping address for sample submissions.

Source: AAI/CML

Leave a Reply

Your email address will not be published. Required fields are marked *