The new facility will provide new testing capabilities to meet industry and changing regulatory requirements
AAIPharma/Cambridge Major Laboratories (AAI/CML), a provider of custom manufacturing and development services for the pharmaceutical and biotechnology industries, will invest up to US$10.7m on relocating its St Louis, MO, US-based analytical testing facility to the Cortex Innovation Centre.
The firm's analytical testing business comprises three centres in St Louis, MO; Wilmington, NC; and Edison, NJ. Its current St Louis facility employs around 80 people and specialises 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 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 this year and transition from the current St Louis location will take place in the first quarter of 2017.
This expansion comes at a critical time in our company's growth
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 other sites will serve as testing support if appropriate. Each existing project will be discussed with customers to ensure a seamless transition.
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 says it will absorb the cost of method transfer exercises, re-verifications or method suitabilities related to the site move, ensuring that relevant regulatory requirements continue to be met.
'This expansion comes at a critical time in our company's growth,' said Stephan Kutzer, CEO, President and Chairman of 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.'