Alcami, a U.S.-based pharmaceutical contract development and manufacturing organization (CDMO), announced the addition of a 3,800 ft² Non-GMP Formulation Development Laboratory (FDL). The dedicated Non-GMP formulation development space, which is co-located within the same facility as Alcami’s parenteral manufacturing operation that offers four isolator filling lines for liquid and lyophilized products, is ready to support customers with Preclinical and Clinical development programs.
“This is a truly a unique offering that will provide our clients’ current and future development programs with flexibility, speed, and a streamlined progression throughout the drug development lifecycle,” commented Louise Hall, Vice President of Formulation Development & Technology Transfer at Alcami Corporation.
Alcami’s Non-GMP Formulation Development Laboratory is outfitted with a high potency suite, lyophilization cycle development center, stability chambers to facilitate lead candidate selection, and the equipment to support a wide variety of research and early-phase development activities, including bench-scale manufacturing of drug product to support Preclinical studies. Furthermore, it is fully integrated within Alcami’s RTP campus, encompassing over 100,000 ft².
“We are pleased to provide our clients with a seamless transition from characterization to formulation and analytical development through GMP manufacturing and analytical release,” added Louise Hall.
About Alcami:
Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. Leveraging 675,000 ft² across the United States, Alcami serves pharmaceutical and biotech companies of all sizes providing customizable and innovative solutions for analytical development, clinical to commercial sterile and oral solid manufacturing, packaging, microbiology, cGMP biostorage, environmental monitoring, and pharmaceutical support services. Alcami’s private equity ownership includes Madison Dearborn Partners and Ampersand Capital Partners.
