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-of-the-art
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/m(3)
(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.