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52 results about "Factor X" patented technology

Factor X, also known by the eponym Stuart–Prower factor, is an enzyme (EC 3.4.21.6) of the coagulation cascade. It is a serine endopeptidase (protease group S1, PA clan). Factor X is synthesized in the liver and requires vitamin K for its synthesis.

Integrated process for the production of therapeutics (human albumin, intravenous immunoglobulins, clotting factor viii and clotting factor ix) from human plasma

The invention relates to an integrated scheme for fractionation and purification of plasma products (human albumin, intravenous immunoglobulin (IVIG), clotting factor VIII and clotting factor IX) by sequential chromatography and virus reduction steps. The therapeutically administrable protein IVIG has purity levels exceeding 98%, aggregates and dimers at less than 0.2%, Fc function of >90% and anti-complementary activity of less than 0.5 CH50 per mg of Ig. The distribution of IgG isomers is comparable to the ranges seen in normal plasma. Human albumin for therapeutic use, purified by this integrated scheme has an electrophoretic purity of close to 100%, with monomers exceeding 98%. The levels of aluminium and pre-kallikrein activator are below the detection limit for the respective tests. The Factor IX preparations have a specific activity of ≧200 IU/mg. The impurity levels of Factor-II, Factor VII, Factor X are at least 10-fold lesser (≦0.5% instead of 5%) and the heparin impurity of ≦0.01 IU (against 0.5 IU limit for this impurity) is 50-fold lesser the specified pharmacopoeial limits.
The purification carried out by an all-chromatography scheme, avoids the use of ethanol precipitation in the entire manufacturing process of the said four plasma products. The invention describes an integrated process for purifying four different proteins from human plasma to high therapeutic grade purity levels, with a potential to purify more therapeutic proteins from a given plasma sample by incorporating additional chromatography steps in the sequence.
Owner:ICHOR BIOLOGICS PTE LTD

Method for detecting quality of Angelica

ActiveCN110376310AFully reflect the efficacy of the characterizationWell supported by scientific dataComponent separationLipid formationFactor X
The invention discloses a method for detecting the quality of Angelica. Pharmacokinetics parameter screening standards such as a lipid-water partition coefficient, an oral bioavailability and a drug-forming property of each matching compound are referred, a compound group with excellent pharmacokinetics and high safety are subjected to second screening, and compounds are taken as 'pharmaceutical component group' associated with the efficacy of the Angelica. Then a measured in vitro/in vivo biological activity of the Angelica is used as a monitoring factor Y and the Angelica 'pharmaceutical component group' is taken as an observation factor X according to the 'substance-efficacy' interaction of the Angelica, a partial least squares regression model of the Angelica biological activity and the 'pharmaceutical component group' is established, components which are positively correlated with the Angelica biological activity and have a high correlation coefficient are found, and the components are taken as a 'quality marker' for the quality evaluation of the Angelica. Finally, a method for determining the content of the 'quality marker' of the Angelica is established by the liquid-mass spectrometry technology, and an industrialization path is provided for the overall quality traceability and control of Angelica medicinal materials or decoction pieces.
Owner:SHAANXI UNIV OF CHINESE MEDICINE
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