Special Focus on Quality-by-Design Considerations
Organized by the AAPS PPB section
Conducted by Michael Siedler, Ph.D., Abbott Bioresearch Center
Your moderator will be Wolfgang Fraunhofer, Ph.D., Abbott Laboratories
Thursday, October 6, 2011; 12:30 pm–2:00 pm
About the Webinar
Applying platform concepts in protein API manufacturing and formulation development is a valuable strategy to efficiently support advancement of preclinical and clinical-stage development projects. This webinar will assess the benefits involved when using technology platforms for the processing of biologic drug products. The speaker will give an overview on how a technology platform can be established and applied for biologics. It is important to understand the criteria that must be met to ensure that a technology platform can be successfully applied, and connecting physico-chemical parameters and target product profiles of the specific development protein to an internal database of more advanced projects (prior knowledge) is a key criterion in that process. The speaker will outline the systematic approach how Prior Knowledge can be leveraged for standardized development and product manufacturing processes in order to demonstrate that a Design & Control Space can be applied for a class of molecules with comparable characteristics (next-in-class molecules). Thus, highest product quality is assured in a coherent Quality by Design (QbD) approach.
This webinar is designed to provide insight into platform concepts and QbD strategies that can be applied to reduce cost, risk and increase chances of success for product development and approval. The speaker will discuss how a rational QbD approach can ensure resource-sparing project acceleration towards a fast FIH. Challenges associated with this approach will be discussed, and solutions using industry case studies and own experience will be provided. The speaker is a member of the ISPE CMC Biotech Working group that has provided a Mab case study to demonstrate how successful implementation of QbD approaches can look like.
- Strategies to employ platform development concepts for biologics
- The importance of prior knowledge and prerequisites needed to verify platform suitability
- Case study of a Drug product development platform to accelerate and de-risk quick FIH studies
- The importance of applying QbD throughout the development cycle of today’s biologics
About the Presenter
Michael Siedler, Ph.D., is a group leader in the NBE Preformulation, Department Global Pharmaceutical Sciences (GPSC) at the Abbott Bioresearch Center, Worcester, USA.
He joined Abbott GmbH & Co KG in 2007 as a lab manger with the Department of Global Formulation Sciences–Parenterals and was involved in the development and implementation of QbD for formulation and process development.
Prior to working with Abbott, Siedler held a position as a lab head and project manager at the Department of Pharmaceutical Technology at Scil Technology GmbH.
He received his Ph.D. in chemistry from the University of Hamburg in 2002.