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Immunoglobulin Preparation And Storage System For An Immunoglobulin Preparation - EP2538975

The patent EP2538975 was granted to CSL Behring on Sep 18, 2019. The application was originally filed on Feb 24, 2011 under application number EP11707382A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP2538975

CSL BEHRING
Application Number
EP11707382A
Filing Date
Feb 24, 2011
Status
Granted And Under Opposition
Aug 16, 2019
Grant Date
Sep 18, 2019
External Links
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OCTAPHARMAJun 18, 2020ULLRICH & NAUMANN PARTG MBBADMISSIBLE

Patent Citations (5) New

Patent citations refer to prior patents cited during different phases such as opposition or international search.

Citation PhasePublication NumberPublication Link
OPPOSITIONEP2453874
OPPOSITIONUS2008275220
OPPOSITIONWO2005049078
OPPOSITIONWO2007092829
OPPOSITIONWO2011008770

Non-Patent Literature (NPL) Citations (21) New

NPL citations refer to non-patent references such as research papers, articles, or other publications cited during examination or opposition phases.

Citation PhaseReference TextLink
DESCRIPTION- S. MISBAH ET AL., CLINICAL AND EXPERIMENTAL IMMUNOLOGY, vol. 158, no. 1, pages 51 - 59-
EXAMINATION- WERNER MAEDER ET AL, "Local tolerance and stability up to 24 months of a new 20% proline-stabilized polyclonal immunoglobulin for subcutaneous administration", BIOLOGICALS, ACADEMIC PRESS LTD., LONDON, GB, vol. 39, no. 1, doi:10.1016/J.BIOLOGICALS.2010.11.004, ISSN 1045-1056, (20110111), pages 43 - 49, (20101202), XP028139185
INTERNATIONAL-SEARCH-REPORT- CLELAND ET AL, "The development of stable protein formulations: A close look at protein aggregation, deamidation and oxidation", CRITICAL REVIEWS IN THERAPEUTIC DRUG CARRIER SYSTEMS, BEGELL HOUSE PUBLISHING INC, US, (19930101), vol. 10, no. 4, ISSN 0743-4863, pages 307 - 377, XP002083452 [A] 1-18 * pages 341-352 *-
INTERNATIONAL-SEARCH-REPORT- QI PEI ET AL, "Characterization of the Photodegradation of a Human IgG1 Monoclonal Antibody Formulated as a High-Concentration Liquid Dosage Form", JOURNAL OF PHARMACEUTICAL SCIENCES, (200909), vol. 98, no. 9, ISSN 0022-3549, pages 3117 - 3130, XP002592759 [X] 1-18 * the whole document *
INTERNATIONAL-SEARCH-REPORT- BOLLI REINHARD ET AL, "L-Proline reduces IgG dimer content and enhances the stability of intravenous immunoglobulin (IVIG) solutions.", BIOLOGICALS : JOURNAL OF THE INTERNATIONAL ASSOCIATION OF BIOLOGICAL STANDARDIZATION JAN 2010 LNKD- PUBMED:19931468, (201001), vol. 38, no. 1, ISSN 1095-8320, pages 150 - 157, XP026939888 [A] 1-18 * page 153, paragraph 3 - page 154, paragraph 1 *
INTERNATIONAL-SEARCH-REPORT- CRAMER M ET AL, "Stability over 36 months of a new liquid 10% polyclonal immunoglobulin product (IgPro10, Privigen) stabilized with L-proline.", VOX SANGUINIS APR 2009 LNKD- PUBMED:19207169, (200904), vol. 96, no. 3, ISSN 1423-0410, pages 219 - 225, XP002592761 [A] 1-18
OPPOSITION- Anonymous, "human normal immunoglobulin for intravenous administration", European pharmacopoeia, (19970101), pages 1 - 6, XP055759087-
OPPOSITION- Anonymous, "HUMAN NORMAL IMMUNOGLOBULIN FOR SUBCUTANEOUS ADMINISTRATION", EUROPEAN PHARMACOPOEIA 8.3, (20150101), pages 1 - 3, XP093134137-
OPPOSITION- BOLLI REINHARD ET AL, "L-Proline reduces IgG dimer content and enhances the stability of intravenous immunoglobulin (IVIG) solutions.", BIOLOGICALS : JOURNAL OF THE INTERNATIONAL ASSOCIATION OF BIOLOGICAL STANDARDIZATION JAN 2010 LNKD- PUBMED:19931468, (20100101), vol. 38, no. 1, pages 150 - 157, XP002592760-
OPPOSITION- CLELAND ET AL., "The development of stable protein formulations: A close look at protein aggregation, deamidation and oxidation", Critical Reviews in Therapeutic Drug Carrier Systems, Begell House Publishing Inc., US, US, (19930101), vol. 10., no. 04., ISSN 0743-4863, pages 307 - 377., XP002083452-
OPPOSITION- Ganguly Ananya, Chandigarh Pearson, Chennai Delhi, "Liquid Solution and Colligative Properties", Fundamentals of PHYSICAL CHEMISTRY for Competitive Examinations, second edition, Pearson, (20120101), pages 1 - 4, Fundamentals of PHYSICAL CHEMISTRY for Competitive Examinations, second edition, (20240222), XP093134135-
OPPOSITION- MAEDER WERNER ET AL, "Local tolerance and stability up to 24 months of a new 20% proline-stabilized polyclonal immunoglobulin for subcutaneous administration.", BIOLOGICALS : JOURNAL OF THE INTERNATIONAL ASSOCIATION OF BIOLOGICAL STANDARDIZATION JAN 2011 LNKD- PUBMED:21257320, (20110101), vol. 39, no. 1, pages 43 - 49, XP002639418-
OPPOSITION- Rao Patricia E., Kroon Daniel J., "Orthoclone OKT3 Chemical Mechanisms and Functional Effects of Degradation of a Therapeutic Monoclonal Antibody", Rao Patricia E., Kroon Daniel J., Y. John Wang and Rodney Pearlman, Stability and Characterization of Protein and Peptide Drugs: Case Histories, Plenum Press, New York, (19930101), pages 135 - 158, XP093134127-
OPPOSITION- TEMPELTON et al., "Rapid Headspace Oxygen Analysis for Pharmaceutical Packaging Applications", Pharmaceutical Technology, (20020700), pages 44 - 61, XP055038908-
OPPOSITION- Zlb Behring Gmbh, "Immune Globulin Subcutaneous (Human) Vivaglobin�", Insert Leaflet, (20160101), pages 1 - 14, XP055415077-
OPPOSITION- WANG et al., "Antibody structure, instability, and formulation", J Pharm Sci, (20070000), vol. 96, no. 1, doi:10.1002/jps.20727, pages 1 - 26, XP009084505
OPPOSITION- QI et al., "Characterization of the Photodegradation of a Human IgG1 Monoclonal Antibody Formulated as a High-Concentration Liquid Dosage Form", JOURNAL OF PHARMACEUTICAL SCIENCES, (20090000), vol. 98, no. 9, doi:10.1002/JPS.21617, XP002592759
OPPOSITION- DAUGHERTY et al., "Formulation and delivery issues for monoclonal antibody therapeutics", Adv Drug Deliv Rev., (20060000), vol. 58, no. 5- 6, doi:10.1016/j.addr.2006.03.011, pages 686 - 706, XP024892149
OPPOSITION- WANG, "Lyophilization and development of solid protein pharmaceuticals", Int J Phann. 2000, (20000000), vol. 203, no. 1-2, doi:10.1016/S0378-5173(00)00423-3, pages 1 - 60, XP002428586
OPPOSITION- CRAMER et al., "Stability over 36 months of a new liquid 10% polyclonal immunoglobulin product (IgPro10, Privigen) stabilized with L- proline", VOX SANGUINIS, (20090400), vol. 96, no. 3, doi:10.1111/J.1423-0410.2008.01143.X, XP002592761
OTHER- Cannell John S., "Fundamentals of stability testing", INTERNATIONAL JOURNAL OF COSMETIC SCIENCE., KLUWER ACADEMIC PUBLISHERS, DORDRECHT., NL, NL , (19851201), vol. 7, no. 6, doi:10.1111/j.1467-2494.1985.tb00423.x, ISSN 0142-5463, pages 291 - 303, XP093109755

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