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Alcami Biologics formed to meet market demands for biological drug development services.
Alcami Corporation has announced the launch of Alcami Biologics, a biopharmaceutical development, analytical testing, manufacturing, and packaging enterprise to advance the commercialization of biological products. The launch, announced in a March 19, 2019 press statement, is in response to increased market demand for outsourced biological drug development services, the company reports.
Alcami Biologics offers analytical development, formulation, and drug product manufacturing of monoclonal antibodies, and other protein and peptide products including biopharmaceutical classification system Class I through Class IV. The company’s laboratories perform cell line characterization studies, analytical testing and cell bank management for cell and gene therapies, drug product manufacturing, sterile fill/finish vial volumes from 2–50 mL at clinical to commercial-scale batch sizes, and stability services.
Alcami Biologics will operate from three company facilities. The Wilmington, NC laboratory will provide analytical development and testing services for protein and peptide biologics, and cell line characterization and analytical testing of cell and gene therapies. Alcami's Durham, NC-based Research Triangle Park headquarters will provide bioassay development. The Charleston, SC site will provide cGMP clinical and commercial parenteral manufacturing and lyophilization services.
"The launch of Alcami Biologics is a significant step forward in the natural progression of our core service offerings and the development of our pipeline," said Alcami chief commercial officer, Syed T. Husain, in the press statement. "We have better positioned ourselves to meet increasing worldwide demand for customized biopharmaceutical solutions and are driving innovation across our global network."