Alcami To Expand HPAPI Capacity
Alcami, a custom development and manufacturing services firm, plans to expand its manufacturing capacity for active pharmaceutical ingredients (APIs) at its facility in Germantown, Wisconsin for highly potent APIs (HPAPIs). Alcami plans to invest in 2016 and 2017 toward enhancement of new and existing kilo labs to introduce the development and manufacturing of HPAPIs.
Two new cGMP-compliant HPAPI production suites will focus on primary containment technologieso with engineering controls designed to meet occupational exposure limit (OEL) of minimally 0.03 Î¼g/cubic meter (SafeBridge Category 3).
The expansion will include a 5,000-square-foot renovation that will be operational by the first quarter of 2017.The newly designed space will include up to 150-liter reactor scale-up with cryogenic capabilities. These advancements follow operational and technology enhancements across development, clinical, and commercial manufacturing to increase production capacity by 50%. The company has global API operations in Germantown, and Weert, The Netherlands.