TETEROW, GERMANY, — Miltenyi Biotec GmbH today announced that the German medical regulatory authorities, the Arzneimittelüberwachungsbehörde (AMÜSt) of Mecklenburg-Vorpommern and the Paul-Ehrlich-Institut (PEI), have granted a license for the manufacture of the clinical lead candidate, MB101, at its GMP facility in Teterow, Germany. MB101 is a proprietary humanized, monoclonal antibody directed against an undisclosed target and is manufactured under recombinant conditions in a mammalian cell line (CHO cells).

“This is a major achievement for Miltenyi Biotec and the MB101 project team. By receiving the manufacturing license, we have finalized an essential project milestone for our clinical trial material of MB101,” explained Dr. Ulf Bethke, Global Head Clinical Products. “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.”

As a fully integrated biopharmaceutical company, Miltenyi Biotec executed all key MB101 project activities in house, including antibody engineering and humanization, cell line development, GMP-compliant manufacturing of drug substance and drug product, QC testing, antibody characterization, and stability studies.