Knowledge Center
Webinar - Quality by Design in the development of drug substance processes
Speakers
Marco Gil,ÌýGeneral Manager, ËÄÉ«AV New JerseyÌý
Rui Loureiro,ÌýProcess Chemistry Development Director
This webinar will illustrate how ËÄÉ«AV has been applying QbD principles in Drug Substance process development. The risk assessment and the design of experiments are two of the most critical activities in the overall methodology. A critical discussion about the key features to address in these phases will be addressed, namely, who to involve, what information should be available and how previous knowledge can be used in streamlining the overall process. Given the complexity of chemical processes, also a critical discussion about risk assessment based on the number of chemical and isolation steps will be performed as a basis to define the steps/unit operations to study.ÌýA case study will be presented covering some aspects of the methodology (preliminary risk assessment, designing experiments and design space definition), how PAT can be used to effectively enhance process understanding in the development phase. Process metrics and business driver’s comparison will be shown based on our experience.
Key learning objectives:
- Linking Critical Quality Attributes to Potential Critical Process Parameters and/or Material Attributes
- Assessing risk using the number of steps to final Drug substance as a factor
- How PAT may be used to enhance process understanding and Design Space definition
Watch On-demand
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