The future of method development is in Analytical Quality by Design, but which tools do we need to get there?
15 Jul 2020
Analytical Quality by Design (AQbD) will start to play a more predominant role in analytical field. Implementing AQbD in your workflows can have several advantages, for example it can make post-approval changes of an analytical method less complicated and time consuming.
An AQbD flow is built-up of different parts, the most important being the Analytical Target Profile (ATP), which defines the requirements of the Critical Quality Attribute (CQA); from there an analytical technique can be selected. Furthermore, the use of a Design of Experiment (DoE) approach is increasing in popularity in analytical method development, as it enables fast and efficient development of robust methods.
In this webinar, Dr. Mark Eggink, Principal Scientist, Byondis, will present on the analysis of an ATP, the AQbD flow, and the benefits of using DoE software in combination with separation software during method development of a size exclusion chromatography method for a mAb/ADC.
- Analytical Quality by Design
- Analytical Target Profile
- Implementation of AQbD in biopharmaceutical development
- Design of Experiments software for monoclonal and ADC assays
Who Should Attend?
- Principal Investigators
- R&D Directors