Christof Finkler, PhD

F. Hoffmann-La Roche AG
Director CMC Policy Technical Development
Christof Finkler received his diploma in chemistry and a doctorate in analytical chemistry from the University of Saarland under the supervision of Prof. Dr. H. Engelhardt.
In November 1997 Christof joined Roche, working in as a team leader biotechnology analytics. In his current position as Section Head Analytical Development and QC Biotech Europe he is responsible for the establishment of new analytical technologies, protein characterization, development and validation of analytical methods and supporting BLA/MAA filings for new products. Christof is the global lead of Roche QbD initiative for large molecules and a member of the EFPIA TDOC Team QbD in Analytics.

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Industry Perspectives on Practical Application of Platform Analytical Procedures
Features
Industry Perspectives on Practical Application of Platform Analytical Procedures

Pharmaceutical and biotechnology companies employ platform analytical procedures in the development stages of their synthetic and biological drug products and are beginning to leverage them for commercial products. This shift is supported by the acceptance of platform procedures in the recently adopted ICH Q2(R2) and ICH Q14. Six case studies are shared in this article to highlight how...