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.
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.