Roberta Marchione

• Oversight of CMC, product development and supply activities for mAb and ADC products

• Implementation and execution of the CMC strategy for monoclonal antibodies • Preparation of CMC regulatory documentation for Ph I/II submissions (IMPD/IND)

• Execution of CMC strategy for development of biopharmaceuticals from pre-clinical to clinical phase • Operational support for CMC-related activities • Preparation of CMC regulatory documentation

• Management of the CMC activities, including ongoing stability studies and DP shelf-life assignment • Monitoring of out-sourced manufacturing activities (CMO, bioassays, labelling/packaging activities) • Writing and review of study plans, SOPs, study reports and CMC sections for regulatory submissions • Laboratory-based team and Project management • Quality document management • Quality assurance support

Manufacturing of protein-based anti-tumor vaccines: • Design, execution and evaluation of protein expression experiments for screening, manufacturability assessment, process development and preclinical research • Optimization of protein expression in bacterial host strains • Implementation of purification strategies, solubility screening and analytical characterization • Protein production supplies in 2-50 mg scale • Interpretation of results and data analysis • Communications to internal and external audiences

Structural and functional characterization of EBV late gene transcriptional pre-initiation complex

Development of a cell-based assay to monitor the nuclear export of unspliced HIV RNA transcripts

Vectorization of therapeutic proteins in cancer cells through a cell-penetrating peptide derived from the EBV ZEBRA protein

Training within European mobility program “Leonardo da Vinci” at HumProTher Laboratory, TIMC-IMAG (UMR 5525), University of Grenoble, France Expression and purification of therapeutic recombinant proteins

Design and synthesis of a substratum mimic to use as a specific ligand for Ribosome Inactivating Proteins