38 results about "Coagulation Factor IX" patented technology

Monoclonal antibodies directed against coagulation factor IX and their use in inhibiting thrombosis are disclosed.

The invention relates to a new, more potent, coagulation factor IX (FIX) expression cassette for gene therapy of haemophilia B (HB). Disclosed is a vector for expressing factor IX protein, the vector comprising a promoter, a nucleotide sequence encoding for a functional factor IX protein and an intron sequence, wherein the intron sequence is positioned between exon 1 and exon 2 of the nucleotide sequence encoding for a functional factor IX protein, and wherein the intron sequence has at least 80% identity to the sequence of SEQ ID NO. 1 as disclosed herein.

An objective of the present invention is to provide an effective pharmaceutical composition or a dosage regimen for preventing and / or treating bleeding, a disease accompanying bleeding, or a disease caused by bleeding. The inventors discovered that by administering a pharmaceutical composition comprising a bispecific antigen-binding molecule that recognizes (a) blood coagulation factor IX and / or activated blood coagulation factor IX and (b) blood coagulation factor X and / or activated blood coagulation factor X according to a given dosage regimen, bleeding, a disease accompanying bleeding, or a disease caused by bleeding can be prevented and / or treated more effectively.

The invention relates to a preparation method of a clinical blood coagulation inspection preparation and particularly relates to a preparation method of a blood coagulation factor IX quality control product. The preparation method comprises the following steps: carrying out affinity chromatography on the mixed blood plasma of multiple persons by using an anti-human blood coagulation factor IX monoclonal antibody immunoaffinity chromatography column, removing a blood coagulation factor IX in the mixed blood plasma of multiple persons to obtain a blood plasma in shortage of the blood coagulation factor IX; mixing the mixed blood plasma of multiple persons with the blood plasma in shortage of the blood coagulation factor IX according to a certain proportion to prepare a blood coagulation factor IX quality control product with the content of the blood coagulation factor IX at different concentration levels, adding a freeze-drying protective additive, carrying out sub-packaging, and carrying out freeze drying so as to obtain the blood coagulation factor IX quality control product. According to the blood coagulation factor IX quality control product prepared by the preparation method, the uniformity, the stability and the stability of freeze-dried aquatic product subjected to re-melting are good, and the quality control product can replace an imported product to be used for quality control on detection of blood coagulation factor IX, so that the reduction of the detection cost is facilitated and the capability of detecting the blood coagulation factor IX in China can be promoted.

A method for the preparation of prion-free vitamin K-dependent proteins in a purification sequence using chromatography, characterized in that: - at least one chromatographic step is performed using a multimodal resin; - vitamin K-containing dependent proteins are provided as an aqueous solution fraction of protein; - contacting fraction containing vitamin K-dependent protein with multimodal resin at pH 6-9; - optional washing with aqueous wash buffer prior to elution of vitamin K-dependent protein Multimodal resin for vitamin K-dependent proteins to wash away contaminants and retain vitamin K-dependent proteins; -Elute vitamin K-dependent from multimodal resins at pH 6-9 in arginine-containing buffers protein; and - optionally collecting the vitamin K-dependent protein-containing fraction in purified or enriched form.

The present invention relates to Factor IX polypeptides conjugated to heparosan (HEP) polymers, methods for the manufacture thereof and uses of such conjugates. The resultant conjugates may be used—for example—in the treatment or prevention of bleeding disorders such as haemophilia B.

The present invention relates to a method for manufacturing a highly purified human blood coagulation factor IX, including: subjecting objects containing human blood coagulation factor IX (derived from human plasma or recombinant cell culture medium) to anion exchange chromatography, cation exchange chromatography, heparin affinity chromatography, preparing the human blood coagulation factor IX, and including: subjecting the S / D treatment (Solvent / Detergent treatment) to inactive viruses or removing the viruses through nanofiltration, thereby obtaining a highly purified, safe coagulation factor IX having a specific activity of above 150 IU / mg, with substantially inactivation or removal of all impure proteins and viruses.

The invention relates to a production method for adsorbing a human complex from plasma by a fixed bed column chromatography technique, which comprises the following steps: (1) cryoprecipitation plasma removal: filtering by using a cellulose deep filter plate which is cleaned by an EDTA (ethylene diamine tetraacetic acid) solution and a sodium citrate solution; (2) filtering the plasma subjected to deep filtration through a 0.2 mu m filter element membrane while fixed bed loading; (3) balancing 2-5 column volumes in a fixed bed chromatographic column filled with anion exchange gel Capto DEAE by using a buffer solution A at the plasma loading flow rate of 60-120 cm / hour, washing the chromatographic column with a buffer solution B, and eluting the chromatographic column with a buffer solution C to obtain a PCC (prothrombin complex concentrate) product. When the calculation is based on coagulation factor IX, the yield of the PCC can reach 75-90%, and the specific activity can reach 5.5 IU / mg above.

The invention relates to pRBE-HCR-hAAT-hFIXml plasmid as well as construction and application thereof. The sequence of the plasmid is represented as SEQ ID NO.17, and the plasmid contains an hAAT promoter, an RBE (rep binding element) and an HCR (hepatic locus control region) control element. The plasmid and rep expression plasmid are injected into a mammal body at high pressure and can be used for targeted integration of an exogenous gene onto a specific site of AAVS1 (adeno-associated virus integration site1) on the No.19 chromosome of a human so as to express a coagulation factor IX of the human. With application of the expression plasmid, the coagulation factor IX of the human can be expressed stably, and the integration efficiency of an integration system in a liver is improved, so that higher expression quantity and longer expression time are achieved.