CAMBRIDGE, Mass. and BOTHELL, Wash., Sept. 9 /PRNewswire/ -- Edimer Pharmaceuticals and CMC Biologics today announce the execution of a manufacturing contract to support the development of EDI200, a clinical-stage recombinant protein for the treatment of X-linked Hypohidrotic Ectodermal Dysplasia (XLHED), a rare genetic disease with orphan designation in the USA and Europe.
CMC Biologics was selected by Edimer for their lead product due to its depth of expertise in protein development, analytical development and its cGMP manufacturing capabilities.
Neil Kirby, Ph.D., Edimer CEO, commented, "CMC's extensive experience in the GMP manufacture of therapeutic proteins makes them an ideal company to help us move this product forward. We believe that this product has the potential for making a difference in individuals' lives that currently have no available therapeutic options."
Gustavo Mahler, Ph.D., CMC Biologics Chief Operating Officer noted, "CMC is delighted to be able to assist Edimer in the development and production of this orphan protein. Our two teams are working together in an open and collaborative manner and we are excited about the project's potential."
Ectodysplasin-A1 (EDA-A1) is a signaling protein expressed in healthy individuals that is involved in the formation of sweat glands, teeth, hair and certain glandular structures. This protein is missing in patients with XLHED. EDI200 is a form of EDA-A1 being developed by Edimer as a treatment for certain patients with XLHED. EDI200 has been shown to substitute for lack of functional EDA-A1 protein in mouse and dog models of XLHED.
About Edimer Pharmaceuticals
Edimer Pharmaceuticals (www.edimerpharma.com)
Edimer is dedicated to deliver a significant and durable improvement in the health and quality of life to future generations affected by XLHED. Edimer was established in 2009 based on research conducted at the University of Lausanne, Switzerland. Edimer's lead product candidate, EDI200, represents the first of a new class of molecules designed to correct a developmental disorder in a pediatric population.
CMC Biologics (www.cmcbio.com) is a leading contract development and manufacturing organization that provides fully integrated biopharmaceutical development and manufacturing services to clients around the world, from its facilities in Copenhagen, Denmark, and Seattle, WA. The company specializes in custom services for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical trials and in-market production. CMC Biologics' wide range of integrated services includes cell line development using its proprietary CHEF1® system, process development and comprehensive analytical testing. CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers both stirred tank and perfusion production processes.
|SOURCE Edimer Pharmaceuticals; CMC Biologics|
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