Hervé Broly, PhD

Hervé is an internationally recognized bioprocess expert with over 42 years of experience in the development, manufacture, and validation of biotech processes. He is credited with 21 patents and has authored 69 scientific papers. Over his 35-year career at Merck-Serono, he served as Vice-President of the Process Development Department. Hervé's expertise spans all CMC aspects of biotechnological products for IND/CTA and BLA/MAA applications, leading to the approval of several BLA/MAA submissions. He has extensive experience in creating high-quality, compliant CMC regulatory documents and developing strategies for complex CMC challenges. Hervé has also played a crucial role in health authority interactions and inspections at company sites.