Luigi joined Progress-PME in January 2020. He is a biotechnology senior consultant with extensive experience in biological drug research and development. He provides scientific expertise and manages development and manufacturing activities in preparation for pre-clinical and clinical studies (Phase I-III). As a senior scientist Luigi is experienced in efficiently executing a problem analysis, followed by planning and providing solutions. He enjoys working in a team and to get the best out of himself and the team members.
He has over 30 years’ experience in research and product development in Business and Academia.
Before joining Progress-PME, Luigi was Project Leader at the Fair Medicine Foundation. He developed new business models for the manufacture and market introduction of affordable biological drugs.
As (Senior) Project Manager at AM-Pharma Luigi was responsible for the management of the outsourced development, GMP manufacture and supply of the lead compound recAP for the treatment of Sepsis Associated Acute Kidney Injury into clinical trial. He has been instrumental in the design of the recombinant protein, cell line development, upstream and downstream process development, tech transfer, scale up and analytical development at various CMOs based in Germany, Switzerland, UK and USA.
Prior to joining AM-Pharma Luigi was a Consulting Scientist in the QC Support group within Centocor, where he was responsible for method validation, and development and implementation of Standard Operation Procedures for in-process testing and final product quality assays for a new antibody-based pharmaceutical drug product CNTO148. This also involved Assay Transfer to and from sister companies within the larger J&J organisation.
Before joining Centocor, Luigi headed the Systems Development and Protein Production groups within two start-up proteomics companies, Glaucus Proteomics and Arrante. His responsibilities included the production of recombinant proteins for clients, customer support and development of new production technologies for the manufacture of protein biochips.
In his position as Research & Development Manager with Packard BioScience (now Perkin Elmer), Luigi was responsible for the introduction of state-of-the-art molecular biology techniques, cell-based assays, training of staff, and management of the R&D department. He co-developed several Luciferase-based high throughput screening assay products. His participation in the US-based corporate business development team led to the identification of novel technologies for robotic nucleic acid isolation, which were subsequently exploited by Agencourt Biosciences. Other responsibilities included supervision of technology transfer for manufacturing of biochips, co-development of biochips with genomics and proteomics companies and the establishment of a clean room facility. As a member of the management team he gained considerable insight in the day-to-day operation of a commercial production facility for high quality biochemical reagents for the drug discovery market.
Luigi (1962) is married and has two children. He enjoys cooking and producing musical noises in his attic recording studio.
- Pre-clinical and clinical development of biopharmaceutical products
- Analytical method development and validation
- Writing IMPD/IB