Fabian Higel | Global NBE CME Expert
Boehringer Ingelheim
Dr. Fabian Higel is a Global CMC Expert at Boehringer Ingelheim with more than ten years of experience in the development of biological drug products across the full lifecycle, from early discovery to market entry. He has held leadership roles across multiple functions within the biopharmaceutical industry and is responsible for shaping global scientific CMC and Quality by Design strategies, including strategic oversight of regulatory enablement and late‑stage development activities for biologics programs.
Appearances:
Festival of Biologics Day 2 @ 14:10
Developability at Boehringer Ingelheim
This talk presents Boehringer Ingelheim’s platform‑based approach to developability for biologics, supporting a broad and diverse pipeline of molecule modalities. It highlights standardized, partially automated screening work packages across upstream processing, downstream purification, and formulation development, designed to generate early, comparable insights under harmonized conditions. By embedding automation, platforming, and risk mitigation into early CMC activities, this approach enables data‑driven candidate selection, improves predictability, and lays a robust foundation for efficient, scalable manufacturing strategies.
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