MORRISVILLE, N.C., July 28, 2020 -- Alcami, a US-based contract development and manufacturing organization (CDMO), is pleased to announce that its 56,000 square foot expansion in Research Triangle Park (RTP), reached the first milestone of operational readiness with the start of GMP laboratory testing this month. This brand-new site with state-of-the-art design and controls became part of Alcami when TriPharm Services was acquired in January 2020. 20,000 square feet will be dedicated to microbiology, formulation development, and analytical chemistry services. Specific investment has been made to offer industry-leading environmental monitoring services from this site in 2020. Operational capabilities will continue to build across the next two years with the completion of Phase 1 of the manufacturing facility in Q4 2020, which will bring the first two filling suites online and the next major milestone.
In support of this build-up, Alcami has added more than 30 employees to the RTP campus and 80 employees company-wide in 2020. Recruiting is ongoing for more than 60 additional positions across all Alcami sites. Alcami is working with the FDA to combine the new site with the existing Alcami laboratory located in Durham, NC, under a single FDA establishment identifier (FEI). The RTP laboratory and manufacturing operations are fully integrated under Alcami’s established quality systems and oversight.
“Alcami offers a unique solution to current supply chain risks with redundant capabilities from an entirely US-based network of facilities that have regulatory qualification to supply major international markets,” said Walt Kaczmarek, Chief Executive Officer of Alcami. “We are pleased to provide modern, reliable manufacturing capacity to support the rapid growth of injectable pharmaceutical and biologic products.”
Alcami is a contract development, manufacturing, and testing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. Approximately 900 Alcami employees across five campuses in the United States serve biologics and pharmaceutical companies of all sizes, helping to deliver breakthrough therapies to patients faster. Alcami provides customizable and innovative solutions for API development and manufacturing, solid state chemistry, formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (oral solid dose and parenteral), packaging, and stability services. Alcami’s private equity owners include Madison Dearborn Partners and Ampersand Capital Partners. For more information, please visit www.alcaminow.com, www.mdcp.com, or www.ampersandcapital.com.