Programme
Symposium C1
Innovative Production Technologies for Biologics
Monday 22 May 2017
15:00-18:00
Stockholmsmässan : K11
Introduction:
The need for high quality biologic drugs, including biosimilars, is fueling innovation in biopharmaceutical manufacturing technologies. This symposium outlines opportunities and challenges associated with new technologies such as single-use bioreactors, continuous purification processing, and real-time quality analysis that have been effectively explored to enable fast scale-up of high-quality complex products. Furthermore, experts will delineate important adaptations in quality risk management that are necessary to assure safety of biologics when employing innovative production technologies.
Chair: Hanns-Christian Mahler (Switzerland)
Programme
15:00 – 15:35 Innovation in Biologics Drug Product development & manufacture
Hanns-Christian Mahler, Lonza, Switzerland
15:35 – 16:10 Quality risk assessment and management for application of single-use systems
Akihko Hirose, National Institute of Health Sciences, Japan
16:10 – 16:30 BREAK
16:30 – 17:05 Control strategies for surfactants in biopharmaceuticals
Roman Mathaes, Lonza, Switzerland
17:05 – 17:40 Assessing the impact of manufacturing processes on drug product composition and stability
Mark Bolgar, Bristol-Myers Squibb, USA
17:40 – 18:00 Panel discussion
Hanns-Christian Mahler, Lonza, Switzerland
