To grow mammalian cells, researchers need to provide an optimal in vitro environment. The key feature of successful cell growth is the culture medium. "Achieving Super Soup" requires finesse and know-how in order to combine the right ingredients at the right times under the right conditions to achieve high titers. This workshop will provide a foundation for optimizing cell culture media presented by real-world experts who will also tailor a portion of the course to fit concerns and challenges faced by the workshop participants.
Frederic Girard, PhD, Managing Director, Eurofins Spinnovation Analytical
Jochen B. Sieck, PhD, Head, Perfusion Systems and Cell Culture Media R&D, Merck Life Science
TThe manufacture of biopharmaceuticals using semi- or fully continuous processes has the potential to improve product quality and increase the productivity of biomanufacturing facilities. This Short Course details the principles and practical challenges of implementing a continuous process strategy. Using examples and shared experiences, the course covers continuous processing definitions and drivers, technologies and processes, process development and control, and quality considerations.
Instructor: Margit Holzer, PhD, Owner, Ulysse Consult
The QbD Roadmap provides a conceptual structure for the development activities of the drug manufacturing process. Coming from the Target Product Profile and subsequent determination of the Critical Quality Attributes (CQAs), the criticality of the process parameters that might have an impact on the CQAs are assessed using risk analysis. Subsequently, the impact of the critical process parameters (CPPs) on the CQAs is typically evaluated using a combined Design of Experiment and Data-driven process modeling strategy.
Gerald Striedner, PhD, Associate Professor, Biotechnology, University of Natural Resources and Life Sciences (BOKU)
Moritz von Stosch, PhD, Senior Manager, Fermentation, GlaxoSmithKline Pharma GmbH
Attendees will gain a critical overview of the complexity and diversity of the aggregation and sub-visible particles of peptide and protein biopharmaceuticals and on strategies to overcome these issues.
Topics to be covered include: Different aggregation mechanisms; Available techniques for detection of aggregation and impurities (leachables) and how these methods can be applied. Combining analytical methods to ensure detection of aggregates, and new technologies for characterization aggregates will be presented. Aggregation of biopharmaceuticals in human plasma and regulatory aspects will also be addressed.
Tudor Arvinte, PhD, Professor, School of Pharmacy Geneva Lausanne, Switzerland and Chairman, CEO, Therapeomic, Inc.
*Separate Registration Required