COMPANY DESCRIPTION
Alcami is a leading contract development and manufacturing organization headquartered in North Carolina, with over 40 years of track record in advancing products through every stage of the development lifecycle to commercial launch. Leveraging its five US-based campuses, Alcami serves pharmaceutical and biotech companies of all sizes for small molecules and biologics, providing a broad range of innovative solutions from analytical development and testing, clinical and commercial sterile and oral solid dose drug product manufacturing, packaging, to cGMP biostorage, environmental monitoring, and pharmaceutical support services. Whether you are a virtual start-up or a large pharmaceutical company, Alcami is committed to delivering seamless coordination to advance your development and manufacturing projects faster. Our deep expertise, state-of- the-art facilities and comprehensive solutions are delivered with exceptional service and maximum flexibility.
COMPANY BACKGROUND
From its humble start over 40 years ago, Alcami has grown to a leading CDMO with 5 campuses across the United States with integrated services from analytical development and testing to drug product manufacturing and biostorage. Our team brings a founder’s mentality and client-centered focus united by a common cause, entrepreneurial spirit, and a passion for customer service. Our unique combination of industry experience, technical expertise, and operational excellence set the foundation for client success while benefiting patients around the globe. We believe these characteristics should influence everything we do in business and life.
MARKETS & FACILITIES
Alcami has been supporting biopharma companies in over 35 countries. Our capabilities include a broad range of routine and custom analytical testing services, small molecule and biologics development and manufacturing, sterile fill-finish and oral solid dose manufacturing, cGMP cold storage, environmental monitoring and cleanroom services, along with a suite of Pharma Support Services – Metrology and Calibration, and Commissioning, Qualification and Validation (CQV) services. We are regularly inspected by global health authorities including the FDA, MPA, Health Canada, TGA, PMDA, MHRA, ANVISA, and IMB. Our facilities are in good standing with all regulatory authorities, including DEA, EPA, and OSHA. Our harmonized Quality Management Systems across all sites and dedicated customer service teams provide reliable expertise and consistent quality you can count on.