Prevention and Detection of Viral and Bacterial Contamination, Viral Clearance Strategies Masterclass

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.

Mylène brings 25 years of extensive experience in the biotechnology industry, having worked with renowned companies such as BiogenIdec, Sano , and Merck-Serono. She has demonstrated exceptional leadership in CMC, contributing directly to multiple clinical and commercial drug substance and drug product manufacturing facilities in both technical and management roles. Prior to transitioning to consultancy, Mylène led a multi-disciplinary CMC team to successfully achieve commercial approval for a biosimilar. Her expertise encompasses process development and validation, innovative technologies, process technology transfer and scale-up, manufacturing operations and investigations, CRO/CMO management, continuous improvement, regulatory requirements, and product launches.