Amsterdam, The Netherlands, July 23, 2013 – Kiadis Pharma B.V., a clinical stage biopharmaceutical company developing treatments for blood cancers, announced today that its Quality Control (QC) laboratory and the associated Quality system has been inspected for good-manufacturing-practice (GMP) by the Dutch Health Care Inspectorate (IGZ) and has fully met the EU GMP standards. As a result, Kiadis Pharma will receive a GMP manufacturing license and GMP certificate for its QC laboratory from the Dutch Ministry of Health, Welfare and Sport.
GMP licensing and certification enables Kiadis Pharma to perform QC release-assays for the clinical trial manufacturing of the Company’s lead product ATIR™, a cellular therapeutic that will enable partially mismatched donor stem cell transplants from family members in blood cancer patients.
Manfred Ruediger, PhD, Chief Executive Officer of Kiadis Pharma, commented: “This is an important milestone for Kiadis Pharma as we are committed to the highest standards of manufacturing. We are delighted that our QC laboratory and the associated Quality system will receive a GMP manufacturing license and GMP certificate. This not only attests to the quality that we have established at Kiadis Pharma, but secures the pathway to take ATIR™ to the next stage of development. ATIR™ is currently in an ongoing Phase II study to confirm and extend some exciting data. We expect the Phase II results in H1 2014.”
