Francois Bertelli

Expert in antibody drug conjugates (ADC) and bispecifics design, molecular modelling, production and characterisation. Pre-clinical in vitro/in vivo project management for mAbs, ADCs, Bispecifics, and T-cell recruitment in Oncology and Immuno-Oncology. Antibody format generation and humanisation, Antigen cloning, expression, purification and characterisation (All analytical methods and Biacore kinetics determination). CMC Management of upstream and downstream Process Characterisation and Validation of Antibody/Antigen (Mammalian Cell culture and Fermentation) for manufacturing using cGMP methods. Work closely with CRO/CMOs for process development. As part of the Technical Operations team for Rare Reagents production and purification, I evaluate and improve the processes for large-scale protein production such as Monoclonal antibodies (Hollow-fiber, perfusion, wavebags, spinners) and the purification processes (Chromatography, Ultrafiltration, Dialysis, TFF). Supporting the Process Validation projects, making sure that activities are compliant with QMS and external guidelines (FDA & EU). * Facilitate risk assessment/FMEA process. * Perform QMS maintenance activities and implement quality improvement activities. * Assures the accuracy and correctness of documentation used during process validation activities. * Provide GMP guidance. 15 years experience in Assay Development and High-Throughput-Screening Project Management. I have a track record in prosecution of drug discovery programmes from idea to candidate nomination, across broad disease, target and physiological systems. I have experience of both leading teams directly and indirectly through matrix-based disciplines Broad knowledge of most of the therapeutic areas for which several HTS campaigns have been run successfully. I have received the project management foundation certficate PRINCE2. Specialties: Pharmacology, Enzymology, Cell-based assays, kinase and Protein-Protein Interaction assays. Project Management Drug Discovery. Protein Charaterisation.