Bio2Business Featured Speaker Series

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Confirmed title: Creating a framework for effective CMO selection for late phase biopharmaceutical drug substance production
Dr Karlheinz Landauer, Managing Director, QBDC GmbH
ABSTRACT
CDMO selection for outsource-seekers is often unstructured and based solely on factual knowledge like company size, track records, available infrastructure, because this information is computable and comparable. However, the best candidates are not those with an impressive track record, reasonable pricing or the right number of bioreactors, but also those with which the outsourcer feels most comfortable, those that radiate a sense of reliability and competence.

In my presentation, I will speak about our way to make outsourcing more structured, and, thus, more sustainable and scientific. In questionnaires, we consider both factual knowledge and personal/subjective impressions, and fill them into a comprehensive scoring system, which allows a more accurate comparison of candidates. Our approach is based on Quality by Design considerations, starting with superficial screening that goes more and more in-depth while the number of CDMOs continuously decreases, until less than a handful of promising candidates are left.

BIOGRAPHY
Dr Karlheinz Landauer is an expert in Biotechnology with a PhD and MSc title in Applied Microbiology and 18+ years of work experience. He has specialized on cell line engineering, up-stream process development, scale-up and tech transfer strategies, GMP operations and was a program manager of an NBE.

After his PhD in animal cell culture medium development, he took several jobs in the above-mentioned fields with increasing responsibilities, when in 2011 he eventually was Head Manufacturing and COO at Celonic AG in Basel.

In 2016, he has founded his own company 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.

COMPANY PROFILE
QBDC GmbH
QBDC GmbH is a consultancy company and software service provider, founded 2016 in Switzerland. We offer services in various CMC topics, like robust process development, tech transfer & scale-up assistance, state-of-the-art facility design & layout, establishing and maintaining compliant quality management, development & optimization of mammalian cell culture media, qualification and validation of facilities & equipment.

Additionally, we offer easy-to-use, inexpensive software solutions for digital document (TEMIS) and data management (METIS), as well as a number of ready-made tools to support decision-making processes, like a biosimilar manufacturability assessment, CQA risk analysis, CDMO/Outsourcing selection guide, facility investment & revenue calculator.

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