Agenda

08.00 - 09.00 Registration
09.00 - 10.15 Hazard Identification
10.15 - 10.30 Break
10.30 - 12.00 Hazard Identification
12.00 - 13.00 Lunch
13.00 - 14.15 Risk Assessment
14.15 - 14.30 Break
14.30 - 16.00 Risk Treatment Plan

Company intro:
BIA Separations specializes in chromatographic purification of the most challenging biomolecules. The ability of a purification process to deal with big vulnerable molecules and stubborn impurities, for example, hcDNA, is a distinctive advantage. BIA’s downstream platforms are based on unique monolithic chromatographic media, namely, CIM® monolithic columns, distinguished for their flow independent performance, resulting in fast separation, concentration, purification and analytics. Elaborate column design reduces shear stress that vulnerable molecules are subjected to, thus significantly increases final recovery. Cutting-edge applications focus on downstream processing of exosomes, viruses (AAV, Influenza, etc.), plasmid DNA, bacteriophages and mRNA. We provide products that range from small analytical columns to large industrial prep-scale columns (including cGMP and disposable units in IEX, HIC, affinity and customized formats). As such, our products are used in research, laboratory, pilot and industrial production stages and are extremely simple to use, with no packing of columns needed.
Lecturers Bio:
Pete Gagnon is a widely respected global authority in the field of downstream processing. He is the author or more than 100 scientific publications and inventor on more than 100 awarded patents in the United States, Europe, and Asia. His expertise covers purification of monoclonal antibodies, virus particles, extra-cellular vesicles, plasmid DNA, and mRNA. He is currently Chief Scientific Officer at BIA Separations, a European manufacturer of specialized chromatography media for purification of gene therapy products.

WHAT TO EXPECT FROM ANNEX 1 & QUALITY RISK MANAGEMENT