Alcami has announced its plans to expand capabilities for development and manufacturing of Active Pharmaceutical Ingredients (APIs) at its Germantown, WI facility. Alcami plans to invest in 2016 and 2017 toward the enhancement of new and existing kilo labs to introduce the development and manufacturing of highly potent APIs. The two new fully qualified cGMP state 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 square foot renovation will be operational by Q1, 2017. The newly designed space will include up to 150L reactor scale with cryogenic capabilities to service a wide range of complex chemistries. These advancements position Alcami to meet the demands of a growing highly potent API market. Coupled with Alcami’s established presence in the potent Drug Product market, this investment strengthens an industry leading end-to-end offering.
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.
“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.” stated Ted Dolan, Chief Operating Officer. The Germantown, WI facility recently completed an FDA General Inspection that resulted in zero 483 observations. This result demonstrates Alcami’s commitment to quality and regulatory compliance.