More than 20 years experience in Process Development (Upstream & Downstream) of mAbs, recombinant proteins (from mammalian cells and E.coli), and adenoviral vectors.
Expert in GMP Manufacturing (Single Use and Stainless Steel technologies) up to 2,000 L bioreactor scale. Regulatory support (CMC) for IMPD and BLA.
Skills include:
- GMP Manufacturing
- Regulatory support (CMC) for IMPD and BLA.
- Expert in Process Characterization and Process Validation.
- Process Validation. Coordination of national and international R&D projects.
- Leading and mentoring.
- Scientific Director and Co- Founder of BetaPro Consulting and CEO at Biotech Academy in Rome.
