Abstract: 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.
Abstract: 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.
Abstract: The present invention describes pharmaceutical compositions containing APOTf for use in preventing (or delaying the onset) and treating autoimmune diseases. Based on the experimental data obtained, the molecule has the surprising capacity to favorably modify the immune response profile both in vitro and in vivo.
Abstract: 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.
Abstract: The present invention provides a process for purifying FV starting from human plasma or a fractionation intermediate thereof, that is simple, scalable to the industrial level and relatively inexpensive compared to the methods described in the literature to date. The invention consists of the use of two anion exchange chromatography steps, the first of which has the purpose of separating the FV from the PTC component factors, while the second has the purpose of isolating the protein of interest from the majority of plasma proteins by means of selective interaction with the weak anion exchange support used. The process developed has also had a viral inactivation step and a viral removal step included, contributing to the safety of the final product obtained, without however significantly altering the process total recovery of FV, and without necessitating the introduction of additional steps for eliminating the inactivating agents used, thanks to the order in which the various steps are conducted.
Abstract: The present invention provides a process for purifying FV starting from human plasma or a fractionation intermediate thereof, that is simple, scalable to the industrial level and relatively inexpensive compared to the methods described in the literature to date. The invention consists of the use of two anion exchange chromatography steps, the first of which has the purpose of separating the FV from the PTC component factors, while the second has the purpose of isolating the protein of interest from the majority of plasma proteins by means of selective interaction with the weak anion exchange support used. The process developed has also had a viral inactivation step and a viral removal step included, contributing to the safety of the final product obtained, without however significantly altering the process total recovery of FV, and without necessitating the introduction of additional steps for eliminating the inactivating agents used, thanks to the order in which the various steps are conducted.
Abstract: 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.