Robert Pletzanauer

Robert Pletzanauer

Company: Takeda

Job title: Head of Process Analytics

Seminars:

Joint Q&A Session 9:30 am

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day: Day One

Exploring the Evolution of Analytical Techniques for Gene Therapy Drug Development 8:30 am

Welcome to the digital age!? • Switching from PCR to ddPCR • Changing from gel to capillary Old but still Gold!? – Analytical UltracentrifugationRead more

day: Day One

Panel: CMC Regulatory Challenges 11:30 am

Length of the storage conditions, GMP status of the storage facilities • Process Controls and Validation Appropriate product characterization and process definition to ensure robust comparability data. Raw Material Qualification: Qualification processes and data for key starting materials Analytical Test MethodsRead more

day: ANALYTICAL REGULATORY FOCUS DAY

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