Kedrion S.p.a.

Alessandra Lazzarotti

Claudio Farina

Claudia Nardini

Ester Ascione

Andrea Morelli

Sabrina Esposito

Arianna Petrucci

Marcella Maddaluno

The present invention provides a process for the production of human plasminogen starting from human plasma or a fractionation intermediate thereof. The main stages of the process are: a step of virus inactivation, in which human plasma is contacted with a solvent/detergent mixture, a single affinity chromatographic step and a virus removal nanofiltration step. This process is scalable up to industrial level and it provides, without adding any protease inhibitor, a functional and intact finished product suitable to be administered for the treatment of human diseases due to genetic plasminogen deficiency.

Process for plasminogen purification starting from human plasma

The invention relates to a novel, industrial-scale process for the purification of gamma-immunoglobulins (IgG) starting from plasma or fractions thereof. The method involves two chromatographic steps, i.e. a cation exchange capture chromatography, and then a polishing anion exchange chromatography, ensuring a highly purified end product, which contains no aggregates, and high yields. The process also involves a virus inactivation step by means of a solvent/detergent treatment to inactivate the viruses with a lipid envelope, and a virus removal step by nanofiltering to ensure the removal of the non-enveloped viruses.

Process for the industrial-scale purification of gamma globulins from human plasma for industrial applications

Growing community of inventors

Massa, Italy

Alessandra Lazzarotti