http://rdf.ncbi.nlm.nih.gov/pubchem/patent/ES-2421736-T3

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http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61P31-12
http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61P43-00
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filingDate 1999-06-09-04:00^^<http://www.w3.org/2001/XMLSchema#date>
grantDate 2013-09-05-04:00^^<http://www.w3.org/2001/XMLSchema#date>
inventor http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_0ccb79c37ba6e5005ee9b77c0b9032f2
http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_5a5aac9153b27f41950dc0f28f02bbeb
publicationDate 2013-09-05-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber ES-2421736-T3
titleOfInvention Procedure for the preparation of immunoglobulins for intravenous administration and other immunoglobulin products
abstract A method for purifying immunoglobulin G (IgG) from a crude plasma protein fraction contains immunoglobulin, wherein the procedure comprises the steps of: (a) preparing an aqueous suspension of the crude plasma protein fraction containing immunoglobulin, so that the IgG concentration in the aqueous suspension is at least about 4 g / l, elpH of the immunoglobulin-containing suspension is within the range of 5.1 to 5.7 and the immunoglobulin-containing suspension is further filtered by depth filtration; (b) adding a substantially non-denaturing, water-soluble protein precipitating agent to said filtered suspension of step (a) in an amount sufficient to cause precipitation of a high proportion of non-immunoglobulin G proteins, aggregate immunoglobulins and particles including potentially infectious particles such as viral particles, without causing substantial precipitation of the monomeric immunoglobulin G, thereby forming a mixture of solid precipitate and supernatant liquid material; wherein the precipitating agent is PEG 3350, PEG 4000 or PEG 6000 within the range of 4 to 10% by weight and incubate from about 2 hours to about 12 hours at a temperature between 2 ° C and 8 ° C; (c) clarifying and recovering a supernatant material containing immunoglobulin G from the mixture of step (b); and thoroughly filter the clarified supernatant material to remove large particles and aggregates; (d) apply the clarified supernatant material containing immunoglobulin G of step (c) to a resin EAEA Sepharose Fast Flow (DEAE) and subsequently to a CM resin Sepharose Fast Flow (CM), where the DEAE resin and CM resin are connected in series and where the buffer used for EAE and CM chromatography is the same buffer, the pH of said buffer is in the range of 5.4 to 5.9 and the conductivity is in the range of 1.0 to 1.4 mS / cm, wash with a column volume of a washed buffer and then disconnect the DEAE and CM columns; (e) wash away the protein contaminants and precipitated proteins from the CM resin of step (d) with a buffer having a pH and an ionic strength sufficient to remove the contaminants from the resin without causing substantial elution of immunoglobulin G , wherein the buffer has a pH between 5.2 and 5.8; (f) eluting immunoglobulin G from the CM resin of step (e) with a substantially non-denaturing buffer having a pH and ionic strength sufficient to cause an effective elution of immunoglobulin G, thereby recovering an eluate containing immunoglobulin G; wherein the elution is performed as a stage with gradient elution from about 125 mM to about 350mM sodium chloride and a pH in the range of 5.2 to 5.8; (g) carry out a diafiltration / ultrafiltration with the eluate containing immunoglobulin G of step (f) to concentrate and / or dialyze the eluate until the conductivity of the ultrafiltered solution is reduced to a value lower than approximately 1.3 mS / cm and wherein the pH is maintained within the range of 4.0 to 6.0, and optionally add a stabilizing agent; (h) perform a virus inactivation step, and (i) if desired, subject the purified solution containing IgG to additional treatments in order to adapt it to a formulation as a liquid product.
priorityDate 1998-06-09-04:00^^<http://www.w3.org/2001/XMLSchema#date>
type http://data.epo.org/linked-data/def/patent/Publication

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Total number of triples: 24.