Prof. Dr. Dirk LütkemeyerManaging Director
Dirk Lütkemeyer, co-founder and managing director of BIBITEC, has more than 20 years of experience and expertise in the area of cultivation of mammalian cells and the purification of proteins. He established and headed a production plant for mammalian cells from 2003 to 2007. During the same period he was member of the board of Newlab Bioquality AG, a service provider for quality control of biopharmaceuticals. Since 2004 he is "qualified person" in accordance to German medicinal law. His teaching activities as a full Professor are in the area of downstream processing and GMP at the University of Applied Sciences in Bielefeld.
Dr. Jörg StuteChemist, head of downstream processing, head of project manager
Jörg Stute has more than 15 years experience in protein purification and joined the team of BIBITEC in 2003. As head of downstream processing he was responsible for the practical application of numerous successful EPO purification processes for clinical trials phase III and additional batches for validation purposes. He managed several process validation studies for the EPO production company Norbitec GmbH and is also involved in the management of projects with academia and industry.
Dr. Kai IdingBiologist, head of upstream processing
Kai Iding has more than 15 years experience in cell cultivation. He has worked in cooperation with renowned national and international companies including Novo Nordisk A/S, Roche Diagnostics GmbH, and Sartorius AG. In 2003 he joined the team of BIBITEC and is in charge of the development of upstream processing strategies, medium optimization and cGMP production.
Dr. Andreas OckenfelsChemist, head of quality control and quality assurance (interim)
Andreas Ockenfels has more than 15 years experience in quality control and quality assurance in the pharmaceutical industry especially under GLP and GMP. He was several years in the position of Director Quality Management at NewLab BioQuality AG and Charles River Biopharmaceutical Services GmbH. During that time he was responsible for different sites. He managed several projects with regard of the implementation, reorganization and harmonization of quality systems at testing and production sites. He managed several projects with regard of the implementation, reorganization and harmonization of quality systems at testing and production sites. Since 2011 he works as independent consultant with focus on quality assurance and control under GMP. During that time he worked several months in a FDA remediation program at a subsidiary of a global pharmaceutical company in Austria, performed several audits of suppliers for the pharmaceutical industry or managed inspections by the FDA.