MORRISVILLE, North Carolina, March 1, 2022 /PRNewswire/ — Alcami, a US-based pharmaceutical contract development and manufacturing organization (CDMO), today announced the addition of a Non-GMP Formulation Development (FDL) laboratory from 3,800 square feet. The space dedicated to the development of non-GMP formulations, which is co-located with Alcami’s parenteral manufacturing operation which offers four isolator filling lines for liquid and freeze-dried products, is ready to support customers with preclinical and clinical development programs.
“This is a truly unique offering that will provide our customers’ current and future development programs with flexibility, speed, and streamlined progression through the drug development lifecycle,” commented Louise roomVice President of Formulation Development and Technology Transfer at Alcami Corporation.
Alcami’s non-GMP formulation development lab is equipped with a high-powered suite, freeze-drying cycle development center, stability chambers to facilitate lead candidate selection and equipment to support a wide variety of early-stage research and development activities, including bench-scale manufacturing of drug product to support preclinical studies. In addition, it is fully integrated into Alcami’s RTP campus, which spans over 100,000 square feet.
“We are excited to offer our customers a seamless transition from characterization, formulation and analytical development to GMP-compliant manufacturing and analytical release,” added Louise room.
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 cycle. Leveraging 675,000 sq. ft. across United States, Alcami serves pharmaceutical and biotechnology companies of all sizes by providing customizable and innovative solutions for analytical development, clinical-to-commercial manufacturing of sterile and oral solids, packaging, microbiology, cGMP biostorage, environmental monitoring and pharmaceutical assistance services. Alcami’s private equity includes Madison Dearborn Partners and Ampersand Capital Partners. For more information, visit alcaminow.com.