Case Study: Design Space Development for Large Molecules in Upstream Processing Concept




 

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Following a target-directed process development approach we design processes delivering the desired quality (QbD)’ by science based development supported by multi-variate data analysis. Recent case-studies will focus on the successes as well as challenges in achieving the desired glycosylation and charge isoforms of monoclonal antibodies by upstream development.

Continuing from the knowledge gained during process development, we systematically characterise the process at small-scale to establish a Design Space predictive for large-scale performance with the goal to gain post-launch flexibility for continuous improvement. Our concept and the challenges of small-scale model qualification, setting a quality target product profile for the cell culture harvest, defining upstream process parameter criticality and the Design Space will be explained with recent case-studies.

Presented by Dr. Corinna Sonderegger, Technical Development Strategy and Planning Manager, Global Biopharmaceutical Operations Sandoz Austria, at IQPC's PAT and Quality by Design for Biopharmaceuticals in May 2010.

Sonderegger discusses:

  • How to effectively establish a design space for biopharmaceutical product
  • Outlining the tools and techniques you will require
  • Effectively using a thorough understanding of CQA’s to establish your design space

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