08.12.16
Alcami plans to expand capabilities for the development and manufacture of Active Pharmaceutical Ingredients (APIs) at its Germantown, WI facility. The two new cGMP Highly Potent API (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 (SafeBridge Category 3).
The 5,000 sq.-ft. renovation will be operational by 1Q17. The new space will include up to 150L reactor scale with cryogenic capabilities to service a wide range of complex chemistries.
These enhancements follow operational and technology enhancements across development, clinical and commercial manufacturing to increase production capacity by 50for its global API operations in Germantown and Weert, The Netherlands.
"This investment in highly potent capabilities is consistent with our vision to be a technology leader and address unmet market needs. Alcami is committed to ongoing investments in our people, technology, equipment, and capabilities to enable us to exceed our customers' needs – from preclinical to commercial," said Ted Dolan, Chief Operating Officer.
The Germantown, WI facility recently completed an FDA General Inspection that resulted in no 483 observations.
The 5,000 sq.-ft. renovation will be operational by 1Q17. The new space will include up to 150L reactor scale with cryogenic capabilities to service a wide range of complex chemistries.
These enhancements follow operational and technology enhancements across development, clinical and commercial manufacturing to increase production capacity by 50for its global API operations in Germantown and Weert, The Netherlands.
"This investment in highly potent capabilities is consistent with our vision to be a technology leader and address unmet market needs. Alcami is committed to ongoing investments in our people, technology, equipment, and capabilities to enable us to exceed our customers' needs – from preclinical to commercial," said Ted Dolan, Chief Operating Officer.
The Germantown, WI facility recently completed an FDA General Inspection that resulted in no 483 observations.