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Stable Anti-Ifnar1 Formulation - EP3769781

The patent EP3769781 was granted to Astrazeneca on Apr 19, 2023. The application was originally filed on Aug 18, 2016 under application number EP20174805A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3769781

ASTRAZENECA
Application Number
EP20174805A
Filing Date
Aug 18, 2016
Status
Granted And Under Opposition
Mar 17, 2023
Grant Date
Apr 19, 2023
External Links
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MAIWALDJan 18, 2024MAIWALDADMISSIBLE

Patent Citations (13) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONUS2011059078
DESCRIPTIONUS4816567
DESCRIPTIONUS7662381
EXAMINATIONUS2014127227
OPPOSITIONWO2009100309
OPPOSITIONWO2013063510
OPPOSITIONWO2014036071
OPPOSITIONWO2014036076
OPPOSITIONWO2014066468
OPPOSITIONWO2016034648
OPPOSITIONWO2016109822
OPPOSITIONWO2017031288
SEARCHWO2009100309

Non-Patent Literature (NPL) Citations (27) 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
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EXAMINATION- HA E ET AL, "PEROXIDE FORMATION IN POLYSORBATE 80 AND PROTEIN STABILITY", JOURNAL OF PHARMACEUTICAL SCIENCES, AMERICAN CHEMICAL SOCIETY AND AMERICAN PHARMACEUTICAL ASSOCIATION, US, (20021001), vol. 91, no. 10, doi:10.1002/JPS.10216, ISSN 0022-3549, pages 2252 - 2264, XP001148131
EXAMINATION- Naoto Inoue ET AL, "Arginine and lysine reduce the high viscosity of serum albumin solutions for pharmaceutical injection", Journal of Bioscience and Bioengineering, (20140501), vol. 117, no. 5, doi:10.1016/j.jbiosc.2013.10.016, ISSN 1389-1723, pages 539 - 543, XP055135662
EXAMINATION- Naoto Inoue ET AL, "Specific Decrease in Solution Viscosity of Antibodies by Arginine for Therapeutic Formulations", Molecular Pharmaceutics, (20140602), vol. 11, no. 6, doi:10.1021/mp5000218, ISSN 1543-8384, pages 1889 - 1896, XP055134481
EXAMINATION- Meera Agarkhed ET AL, "Effect of Polysorbate 80 Concentration on Thermal and Photostability of a Monoclonal Antibody", AAPS PharmSciTech, (20121114), vol. 14, no. 1, doi:10.1208/s12249-012-9878-0, pages 1 - 9, XP055350741
OPPOSITION- Carl Roth®, "Biological Buffers", Technical Info, (20200201), pages 1 - 5, XP093157798-
OPPOSITION- "Chapter 8 - Development of delivery device technology to deal with the challenges of highly viscous mAb formulations at high concentration", Steven J. Shire, Monoclonal Antibodies: Meeting the Challenges in Manufacturing, Formulation, Delivery and Stability of Final Drug Product, Woodhead Publishing, (20150101), pages 153 - 162, XP093157792-
OPPOSITION- WANG W; SINGH S; ZENG D L; KING K; NEMA S, "Antibody Structure , Instability and Formulation", Journal of Pharmaceutical Sciences, US , (20070101), vol. 96, no. 1, doi:10.1002/jps.20727, ISSN 0022-3549, pages 1 - 26, XP009084505
OPPOSITION- Nicholas W. Warne, "Development of high concentration protein biopharmaceuticals: The use of platform approaches in formulation development", European journal of pharmaceutics and biopharmaceutics, ELSEVIER SCIENCE PUBLISHERS B.V., AMSTERDAM., NL, NL , (20110601), vol. 78, no. 2, doi:10.1016/j.ejpb.2011.03.004, ISSN 0939-6411, pages 208 - 212, XP055534222
OPPOSITION- Naoto Inoue, Eisuke Takai, Tsutomu Arakawa, Kentaro Shiraki, "Arginine and lysine reduce the high viscosity of serum albumin solutions for pharmaceutical injection", Journal of Bioscience and Bioengineering, Society for Biotechnology, (20140501), vol. 117, no. 5, doi:10.1016/j.jbiosc.2013.10.016, ISSN 13891723, pages 539 - 543, XP055135662
OPPOSITION- Shujing Wang, Ning Zhang, Tao Hu, Weiguo Dai, Xiuying Feng, Xinyi Zhang, Feng Qian, "Viscosity-Lowering Effect of Amino Acids and Salts on Highly Concentrated Solutions of Two IgG1 Monoclonal Antibodies", Molecular Pharmaceutics, American Chemical Society, US, US , (20151207), vol. 12, no. 12, doi:10.1021/acs.molpharmaceut.5b00643, ISSN 1543-8384, pages 4478 - 4487, XP055385371
OPPOSITION- Naoto Inoue, Eisuke Takai, Tsutomu Arakawa, Kentaro Shiraki, "Specific Decrease in Solution Viscosity of Antibodies by Arginine for Therapeutic Formulations", Molecular Pharmaceutics, American Chemical Society, (20140602), vol. 11, no. 6, doi:10.1021/mp5000218, ISSN 15438384, pages 1889 - 1896, XP055134481
OPPOSITION- Anonymous, "Krebs-Henseleit (KH) Buffer", Cold Spring Harbor Protocols, doi:10.1101/pdb.rec581, (20060601), pages 1 - 1, Cold Spring Harbor Protocols , URL: https://cshprotocols.cshlp.org/content/2006/1/pdb.rec581.full?text_only=true, (20240604), XP093170085
OPPOSITION- Carmen Gonzalez-Castillo, "Coronary flow-induced inotropism is modulated by binding of dextrans to the endothelial luminal surface", American Journal of Physiology Heart and Circulatory Physiology, American Physiological Society, US, US , (20030401), vol. 284, no. 4, doi:10.1152/ajpheart.00323.2002, ISSN 0363-6135, pages H1348 - H1357, XP093157795
OPPOSITION- Avram Goldberg;Thomas Geppert;Elena Schiopu;Tracy Frech;Vivien Hsu;Robert W Simms;Stanford L Peng;Yihong Yao;Nairouz Elgeioushi;Linda Chang;Bing Wang;Stephen Yoo, "Dose-escalation of human anti-interferon-? receptor monoclonal antibody MEDI-546 in subjects with systemic sclerosis: a phase 1, multicenter, open label study", Arthritis Research & Therapy, GB , (20140224), vol. 16, no. 1, doi:10.1186/ar4492, ISSN 1478-6354, pages 1 - 12, XP021184149
SEARCH- SHARMA V K ET AL, The fomulation and delivery of monoclonal antibodies, THERAPEUTIC MONOCLONAL ANTIBODIES : FROM BENCH TO CLINIC, WILEY, HOBOKEN, NJ, PAGE(S) 675 - 711, (20090101), ISBN 978-0-470-11791-0, XP009143115 [A] 1-15 * page 14 *
SEARCH- WANG W ET AL, "ANTIBODY STRUCTURE, INSTABILITY, AND FORMULATION", JOURNAL OF PHARMACEUTICAL SCIENCES, AMERICAN CHEMICAL SOCIETY AND AMERICAN PHARMACEUTICAL ASSOCIATION, US, (20070101), vol. 96, no. 1, doi:10.1002/JPS.20727, ISSN 0022-3549, pages 1 - 26, XP009084505 [A] 1-15 * page 15 *
SEARCH- BRUCE A. KERWIN, "Polysorbates 20 and 80 used in the formulation of protein biotherapeutics: Structure and degradation pathways", DISSOLUTION PROFILE OF NOVEL COMPOSITE PELLET CORES BASED ON DIFFERENT RATIOS OF MICROCRYSTALLINE CELLULOSE AND ISOMALT, (20080801), vol. 97, no. 8, doi:10.1002/jps.21190, ISSN 0022-3549, pages 2924 - 2935, XP055015864 [A] 1-15 * abstract *
SEARCH- SZYMCZYK KATARZYNA ET AL, "Aggregation behavior of Triton X-114 and Tween 80 at various temperatures and concentrations studied by density and viscosity measurements", JOURNAL OF THERMAL ANALYSIS AND CALORIMETRY, KLUWER, DORDRECHT, NL, vol. 126, no. 1, doi:10.1007/S10973-016-5631-3, ISSN 1388-6150, (20160705), pages 315 - 326, (20160705), XP036052597 [AP] 1-15 * page 324, column R *

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