Leonardo has over 20 years experience in Process Development (Upstream & Downstream) of mAbs, recombinant proteins (from mammalian cells and E.coli) and adenoviral vectors. Leonardo has held senior roles in a number of biopharmaceutical organisations including Menarini Biotech, IBI-Lorenzini S.p.A and ReiThera srl. Leonardo holds a Master's Degree in Biology from University “La Sapienza” - Rome.
Skills include:
- GMP Manufacturing: single use and stainless steel technologies up to 2,000 L bioreactor scale
- Regulatory support: CMC for IMPDs and BLAs.
- Process Development: USP and DSP expertise in Process optimisation and process characterisation, including QbD approaches.
- Process Validation: Design of Process Performance Qualification and their execution.
- Training: training in process development and process validation.
- Leading and mentoring.
