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CDMO Alcami adds HPAPI capacity and cryogenic capabilities to its Wisconsin facility.
CDMO Alcami, formed earlier in 2016 through a combination of AAIPharma Services and Cambridge Major Laboratories, plans to expand capabilities for development and manufacturing of APIs at its Germantown, WI facility, the company announced on Aug. 11, 2016. The company plans to enhance new and existing kilo labs to introduce the development and manufacturing of highly potent APIs (HPAPIs).
Two new cGMP HPAPI production suites will focus on primary containment technologies with engineering controls designed to meet the established Occupational Exposure Limit (OEL) of minimally 0.03 μg/m3 (i.e., SafeBridge Category 3). The 5000-ft2 renovation will be operational by the first quarter of 2017. The newly designed space will include reactors of up to 150-L scale and cryogenic capabilities to service a wide range of complex chemistries.
These advancements follow operational and technology enhancements across development, clinical, and commercial manufacturing to increase production capacity by 50%. This positions Alcami’s global API operations (Germantown, WI and Weert, The Netherlands) to meet the increasing demand of new clinical candidates, of which greater than 70% originate from small and mid-size pharma and biotech. The Germantown, WI facility recently completed an FDA General Inspection that resulted in zero 483 observations, the company notes.