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news.The Arzneimittelüberwachungsbehörde (AMÜSt) of Mecklenburg-Vorpommern and the Paul-Ehrlich-Institut (PEI), the German medical regulatory authorities, have granted manufacturing license for therapeutic antibody MB101 to Miltenyi Biotec.
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The license allows the company to manufacture the humanized, monoclonal antibody under recombinant conditions in a mammalian cell line (CHO cells) in its GMP facility in Teterow, Germany.
Miltenyi clinical products global head Dr Ulf Bethke said that an essential project milestone for the company’s clinical trial material of MB101 was finalized by receiving the manufacturing license.
"MB101 is a promising candidate within our therapeutic antibody development pipeline, for which we are currently preparing a clinical Phase I study scheduled to begin in the 2nd half of 2013," Bethke added.
Vital MB101 project activities such as antibody engineering and humanization, cell line development, GMP-compliant manufacturing of drug substance and drug product, QC testing, antibody characterization, and stability studies were all accomplished at the facility.