Karlheinz Landauer
Quality Biotech Development & Cells GmbH, Switzerland
Biography
Karlheinz Landauer holds a PhD in Applied Microbiology, focus on animal cell culture technologies, with 20 years of work experience. He has specialized in cell line engineering, upstream process development, scale-up and tech transfer strategies, GMP operations and was a program manager of an NBE (=new biological entity). He had several positions in the above-mentioned fields with increasing responsibilities. His career started at igeneon GmbH in Vienna, later he moved to Celltrion R&D Center when in 2011 he eventually was Head Manufacturing and COO at Celonic AG in Basel. In 2016, he has founded QBDC, with its core focus on consultancy for biotech companies in CMC matters, process development, tech transfer & scale-up, facility layout & design, project management, and QM & QA. At QBDC, he is driving the company towards high-quality standards and problem-solving communication strategies. For QBDC’s customers, he is an easily accessible, goal-oriented technical solution provider.
Abstract
Abstract : How to start a Biosimilar development: A risk based approach