CEINGE - Biotecnologie Avanzate

The team: Prof A Nicosia, Dr A Folgori, Dr S Colloca, Dr F Troise

Expertise: The team has developed expertise in the field of HCV and in development of biologics through lead optimization, pre-clinical toxicity, GMP manufacturing, regulatory and clinical testing. They are world-leaders in characterisation of HCV infection mechanisms and receptors and in the development of active and passive immunotherapeutics and vaccines. The team has developed and/or established a number of key supporting technologies, e.g. generation, production and characterisation of human monoclonal antibodies. They have successfully conducted Phase I and Phase Ib HCV vaccine clinical trials in healthy subjects and in HCV infected patients.

Role in the project: They are establishing a high producer stable cell clone fo production of toxicology and GMP clinical lots of the anti-SR-BI human mAb. In collaboration with P1 they will validate the in vitro activity of the antibody against different HCV strains and with P5 it will establish the effective in vivo dose for prevention of HCV infection in the chimeric mouse model. P4 will work together with P3 to establish a production and purification process for the anti-SR-BI mAb amenable to GMP manufacturing. P4 will also be responsible for appropriate pre-clinical safety and toxicology testing.