Abstract
A new human liquid intravenous immunoglobulin product, Flebogamma ® DIF, has been developed. This IgG is purified from human plasma by cold ethanol fractionation, PEG precipitation and ion exchange chromatography. The manufacturing process includes three different specific pathogen clearance (inactivation/removal) steps: pasteurization, solvent/detergent treatment and Planova™ nanofiltration with a pore size of 20 nm. This study evaluates the pathogen clearance capacity of seven steps in the production process for a wide range of viruses through spiking experiments: the three specific steps mentioned above and also four more production steps. Infectivity of samples was measured using a Tissue Culture Infectious Dose assay (log 10 TCID 50) or Plaque Forming Units assay (log 10 PFU). Validation studies demonstrated that each specific step cleared more than 4 log 10 for all viruses assayed. An overall viral clearance between ≥13.33 log 10 and ≥25.21 log 10, was achieved depending on the virus and the number of steps studied for each virus. It can be concluded that Flebogamma ® DIF has a very high viral safety profile.
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