SC1: Continuous Processing Masterclass

Monday 18 March, 13:00 – 16:00

The 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.

Continuous Bio-processing is currently an innovation focus of many companies, universities and regulatory bodies. The main target is process intensification which should allow cost reduction. The short course will:

• Clarify definitions in this field
• Give an overview of possible continuously run up- and down-stream unit operations
• Explain development strategies
• Highlight factors to consider for process integration and give examples
• Show possible on/at and off-line process monitoring and control strategies
• Summarize important quality considerations

Mabs will serve as main examples during the course, but principles can also be applied to other product classes.

Biography

Margit Holzer is a biochemical engineer with extensive expertise in the development and implementation of biochemical/technological production processes. She holds a PhD in biotechnology from the University of Natural Resources and Applied Life Sciences in Vienna (Austria). Margit has worked all over Europe for Boehringer-Ingelheim and Novasep, she held various positions in R&D, production and manufacturing, quality, technology, including several executive positions such as Technology Director. Amongst other achievements, she has led a successful FDA inspection on a pharma and biopharma production site as quality director. She has also created and headed a Business Unit. She has been involved in the process development of more than 50 different biopharmaceuticals of different origins (recombinant and non-recombinant cell cultures, yeasts, microorganisms, viruses, plants and fluids from vertebras). Currently she works as Scientific Director at Ulysse-Consult.