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news.Anthera Pharmaceuticals has selected the Merck BioManufacturing Network in the UK, to manufacture the large scale GMP clinical and pre-commercial supplies of A-623, an investigational novel peptibody in development for a number of autoimmune diseases.
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A-623 will be manufactured in the Billingham, UK facility of the network.
Anthera Pharma has previously begun enrollment in Pearl-SC, a Phase 2b clinical study in Lupus patients, which was designed to demonstrate that inhibition of both membrane bound and soluble BAFF with A-623 will improve patient clinical outcomes as measured by a composite SLE responder index.
Anthera Pharma president and CEO Paul Truex said establishing a rapid and high quality supply of A-623 for the current and future clinical programs is a critical element of our strategic plan and provides a number of potential development options.
"The selection of the Merck BioManufacturing Network provides world-class, large molecule manufacturing capabilities at all stages of production with the necessary expertise to accelerate the development of A-623 in Systemic Lupus Erythematosus and other autoimmune diseases," Truex said.
Merck BioManufacturing Network (known outside the US and Canada as MSD BioManufacturing Network) is a full service CMO providing development and manufacturing services for biologics to pharmaceutical and biotechnology companies.