Monday, 19 March 2018 | 13:00 to 16:00
SC2: Continuous Processing Masterclass
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, PhD, Owner, Ulysse Consult
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.