The International Conference on Harmonization Q8 (revision 2) guidelines on Pharmeuctical Development describe the principles of Quality by Design (QbD) and were approved in 2008. Yet in a 2014 survey of the biopharmaceutical industry only 16% of respondents said they had fully implemented QbD. In order to facilitate understanding and aid adoption of the technique, Parker domnick hunter will present a case study illustrating the core principles, useful frameworks and points to consider when implementing a QbD strategy.
This webinar describes how a control strategy can be defined based on sound science and quality risk management through the use of a case study based upon the sterilization of a biopharmaceutical by normal flow filtration. An approach to establishing process parameters based on critical quality attributes will be discussed along with the use of multivariate experiments using scale down models for process
characterization.This information will help biomanufacturers integrate their process control strategy into their overall control strategy and ultimately their post approval life cycle management plan.
Register today to start applying these concepts to your bioprocess.
Dr. Peter Schwarz,
Research & Development Manager Process Filtration
Dr. Peter Schwarz has worked with Donaldson for 10 years and is the Research & Development Manager for the global Process Filtration Division. He studied chemistry at the University Saarbruecken and got his Ph.D. with Columbia University in the City of New York/USA. During that time he won several awards like the Young Chemist Award by the Association of German Chemists or the scholarship by the State of Saarland. Based on his former position as Head of QAU he’s familiar with various quality systems like GLP etc. At Donaldson he is responsible for the liquid, steam and sterile air product portfolio.
Nick Hutchinson
Global Market Development Manager
Dr Nick Hutchinson has a Masters and Doctorate in Biochemical Engineering from University College London, UK where he focused on laboratory tools for rapid bioprocess development and characterization. He then worked at Lonza Biologics in an R&D function investigating novel methods for large-scale antibody purification before moving to an operational role scaling-up and transferring manufacturing processes between Lonza sites in the UK, Spain and USA. Nick now works in Market Development at Parker domnick hunter where his focus is in bringing Parker's strengths in Motion & Control to Bioprocessing. This will enable our customers to improve the quality and deliverability of existing and future biopharmaceuticals.
- Understand the drivers for QbD during biopharmaceutical development
- Learn how to develop a framework for identifying critical process parameters
- Learn how to define relationships between critical process parameters and quality attributes
- Learn how to create process design spaces and integrate these into an overall control strategy
- Purification Scientists
- Downstream Process Development
- Operations Managers
- Manufacturing Science and Technology
- Automation Engineers
