Alcami, a U.S.-based pharmaceutical contract development and manufacturing organization (CDMO), is strengthening its capabilities with the addition of a 3,800 square foot 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,” said Louise Hall, vice president of formulation development and technology transfer, 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. In addition, it is fully integrated within Alcami’s RTP campus, encompassing over 100,000 square feet of space.

Hall added, “We are pleased to provide our clients with a seamless transition from characterization to formulation and analytical development through GMP manufacturing and analytical release.”