AAI Pharma and CML merged in 2013, to form a full-service contract manufacturing organisation (CMO) and two-and-a-half years on the firm has said the integration between the two units has led to “dramatic advancements in efficiency.”
According to the CMO, it has managed to manufacture and release late-stage clinical trial materials from an active pharmaceutical ingredient (API) made under GMP, through to the sterile drug product within 79 days.
This is around 65% of the 230 days AAI/CML said is the industry standard for non-integrated approaches, and marks the first time the company has produced both GMP API and GMP Drug Product in continuous end-to-end fashion.
“We have streamlined and integrated to create world class solution for small to mid-sized pharma & biotech companies for clinical trial material by providing a broad range of services across all seven of our sites and businesses,” CEO Stephan Kutzer said in a statement.
“Our technical and regulatory expertise differentiates AAI/CML as we proactively guide and advise our clients through all the clinical phases. The integrated manufacturing services further complement our ProForm SelectTM service offering for a fuller end-to-end solution.”
The announcement comes weeks after the CMO announced it was investing $11m (€10m) into a new facility at its Cortex innovation centre in St Louis, Missouri.