IMMUNOGENETICS-TELETHON SERVICE FACILITY FOR PRODUCTION AND HIGH GRADE QUALITY PURIFICATION OF MONOCLONAL ANTIBODIES

Monoclonal antibodies (mAbs) are key tools produced in the laboratory for research, diagnosis and treatment of many human pathologies in virtue of their characteristics which enable a selective identification of cell targets. Standard quality mAbs on a scale of few mg are required by many research laboratories, but costs are frequently prohibitive; hence, many laboratories turn to independent production for mAbs requirements on this scale. On the other hand, the processing capacity to meet demand for mAbs of high clinical-grade quality is a major bottleneck in the biotech industry.New issues are the production capacity for new mAbs that may come out of the genome project for rare diseases, and the hampered of in vivo application of results obtained in the laboratory due to restrictive regulations and costs. Thus, the in-house production of mAbs according to GMP standards became mandatory if these potential reagents are ever to come from the bench to the bedside. The proposal for a Telethon Research Service outlines the most effective ready-to-use platform for mAbs expansion and purification up to clinical-grade standard. Samples of high purity are often produced via a highly selective single step. However, an appropriate combination of chromatographic materials in at least two or more steps followed by quality-control tests of the purified reagent is mandatory for obtaining clinical-grade mAbs, ranging from milligram-to-gram scale per batch.The optimized platform of bioprocessing is rapid, efficient, reproducible and characterized by costs which are affordable for a medium-sized laboratory.They have represented the basis for the production of high-quality clinical mAbs, a service already extended to external national and international Institutes and for implementing immunotherapeutic protocols transferred to clinical medicine, that has given to our Laboratory, as recently recognized by the Aspen Institute Italia, a co-leadership in the field of Italian biomedicine.