Kedrion S.p.a.

Claudia Nardini

Claudio Farina

Alessandra Lazzarotti

Filippo Mori

Ester Ascione

Ilaria Nardini

Arianna Petrucci

Marcella Maddaluno

Andrea Morelli

Sabrina Esposito

Rodolfo Franceschini

Cristina Angelini

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

There is described a chromatographic purification process that allows highly purified von Willebrand factor (vWF) and Fibronectin (Fn) to be obtained, starting from a biological fraction enriched in vWF and Fn and easily scaled up to industrial level. Chromatographic purification was obtained by a strong anionic exchange resin. The concentrates obtained have a high specific activity and, given the low content of contaminant proteins, are particularly suitable for therapeutic use.

Process for highly selective purification of two plasma proteins: von willebrand factor (vWF) and fibronectin (Fn)

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

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Lucca, Italy

Claudia Nardini