According to Alcami, a pharmaceutical and biotechnology supplier with facilities in the Netherlands and the US, the additional highly Potent API production capacity will help to meet a growing industry demand.
The project will include an upgrade of existing kilo labs, as well as two new fully qualified cGMP Highly Potent API production suites.
Designed with an emphasis on primary containment technologies, the suites will be dedicated to the development and manufacturing of Highly Potent APIs for the potent Drug Product market. These will meet the established Occupational Exposure Limit (OEL).
The new facilities will incorporate up to 150L reactor scale with cryogenic capabilities. Construction will begin this year to be operational by Q1, 2017.
Chief Operating Officer, Ted Nolan, said the investment in highly potent capabilities will “address unmet market needs.”
The expansion will increase Alcami’s API production capacity by 50%.
The announcement comes just five months after the amalgamation of AAIPharma Services Corporation and Cambridge Major Laboratories, Inc. to form the organisation today known as ‘Alcami’.
Since then the firm has expanded production and testing capacity.
In June, it converted Approximately 5,000 square feet of space at its technology center in Wilmington, North Carolina into a laboratory.
The conversion included space for dissolution testing (Apparatus I, II, III, IV and intrinsic dissolution), Karl Fischer testing (humidity controlled room), microbiology, and formulations development.