Lyophilization Above Collapse - EP3572073

The patent EP3572073 was granted to Wyeth on Dec 20, 2023. The application was originally filed on Aug 5, 2009 under application number EP19181153A. The patent is currently recorded with a legal status of "Revoked".

EP3572073

WYETH
Application Number
EP19181153A
Filing Date
Aug 5, 2009
Status
Revoked
May 9, 2025
Grant Date
Dec 20, 2023
External Links
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STRAWMANSep 18, 2024VOSSIUS & PARTNER PATENTANWALTE RECHTSANWALTE MBBADMISSIBLE

Patent Citations (12) New

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

Citation PhasePublication Number
OPPOSITIONEP2323629
OPPOSITIONEP3572073
OPPOSITIONRU2111426
OPPOSITIONWO2005117962
OPPOSITIONWO2006029467
OPPOSITIONWO2006081320
OPPOSITIONWO2009158529
OPPOSITIONWO2010017296
OPPOSITIONWO9414422
OPPOSITIONWO9944604
SEARCHWO2005117962
SEARCHWO9414422

Non-Patent Literature (NPL) Citations (22) New

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

Citation PhaseReference Text
DESCRIPTION- ADAMS et al., "Optimizing the lyophilization cycle and the consequences of collapse on the pharmaceutical acceptability of Erwinia L-Asparaginase", J. of Pharmaceutical Sciences, (19961200), vol. 8606, no. 12
DESCRIPTION- "Collapse during freeze-drying-Qualitative and quantitative aspects", MACKENZIE, Freeze-Drying and Advanced Food Technology, Academic Press, (19740000), pages 277 - 307
DESCRIPTION- "Fundamentals of freeze-drying", NAIL S. L. et al., Development and manufacture of protein pharmaceuticals, Kluwer Academic/Plenum Publishers, pages 281 - 353
DESCRIPTION- PIKAL et al., "Freeze-drying of proteins. Part 2: formulation selection", BioPharm, (19900000), vol. 3, pages 26 - 30
DESCRIPTION- SHALAEV et al., "Thermophysical properties of pharmaceutically compatible buffers at sub-zero temperatures: implications for freeze-drying", Pharmaceutical Research, (20020000), vol. 19, no. 2, pages 195 - 201, XP002640246
DESCRIPTION- S. PASSOT et al., "Effect of product temperature during primary drying on the long-term stability of lyophilized proteins", Pharm. Dev. and Tech., (20070000), vol. 12, pages 543 - 553
DESCRIPTION- WILLIAMS N. A. et al., "The lyophilization of pharmaceuticals; A literature review", J. Parenteral Sci. Technol., vol. 38, pages 48 - 59, XP000670830
DESCRIPTION- R. BELLOWS et al., "Freeze-drying of aqueous solutions: maximum allowable operating temperature", Cryobiology, (19720000), vol. 9, doi:doi:10.1016/0011-2240(72)90179-4, pages 559 - 561, XP055212212
DESCRIPTION- PIKAL et al., "The collapse temperature in freeze-drying: dependence of measurement methodology and rate of water removal from the glassy phase", International Journal of Pharmaceutics, (19900000), vol. 62, doi:doi:10.1016/0378-5173(90)90231-R, pages 165 - 186, XP025544164
DESCRIPTION- WANG et al., "Lyophilization and development of solid protein pharmaceuticals", Int. J. Pharm., vol. 203, doi:doi:10.1016/S0378-5173(00)00423-3, pages 1 - 60, XP002428586
DESCRIPTION- CARPENTER, J. F. et al., "Rational design of stable lyophilized protein formulations: some practical advice", Pharmaceutical Research, (19970000), vol. 14, no. 8, doi:doi:10.1023/A:1012180707283, pages 969 - 975, XP002303280
DESCRIPTION- TANG X. et al., "Design of freeze-drying processes for pharmaceuticals: Practical advice", Pharm. Res., (20040000), vol. 21, doi:doi:10.1023/B:PHAM.0000016234.73023.75, pages 191 - 200, XP002370775
OPPOSITION- Anonymous, "Sublimation (phase transition)", Wikipedia, (20240724), pages 1 - 10, Wikipedia, URL: https://en.wikipedia.org/w/index.php?title=Sublimation_(phase_transition)&oldid=1236383297, XP093224113
OPPOSITION- JOHNSON R E, KIRCHHOFF C F, GAUD H T, "Mannitol-sucrose mixtures- Versatile formulations for protein lyophilization.", Journal of Pharmaceutical Sciences, Wiley, United States, United States, (20020401), vol. 91, no. 4, doi:10.1002/jps.10094, ISSN 0022-3549, pages 914 - 922, XP002502335
OPPOSITION- Wang D.Q., Hey J.M., Nail S.L., "Effect of Collapse on the Stability of Freeze-Dried Recombinant Factor VIII and α-amylase", Journal of Pharmaceutical Sciences, Wiley, United States, United States, (20040501), vol. 93, no. 5, doi:10.1002/jps.20065, ISSN 0022-3549, pages 1253 - 1263, XP009558264
OPPOSITION- Chatterjee Koustuv, Shalaev Evgenyi Y, Suryanarayanan Raj, "Partially Crystalline Systems in Lyophilization: II. Withstanding Collapse at High Primary Drying Temperatures and Impact on Protein Activity Recovery", Journal of Pharmaceutical Sciences, Wiley, United States, United States, (20050401), vol. 94, no. 4, doi:10.1002/jps.20304, ISSN 0022-3549, pages 809 - 820, XP093224094
OPPOSITION- Luthra Sumit, Obert Jean-Philippe, Kalonia Devendra S., Pikal Michael J., "Investigation of Drying Stresses on Proteins during Lyophilization: Differentiation between Primary and Secondary-Drying Stresses on Lactate Dehydrogenase Using a Humidity Controlled Mini Freeze-Dryer", Journal of Pharmaceutical Sciences, Wiley, United States, United States, (20070101), vol. 96, no. 1, doi:10.1002/jps.20758, ISSN 0022-3549, pages 61 - 70, XP093224098
OPPOSITION- James D. Colandene, Linda M. Maldonado, Alma T. Creagh, John S. Vrettos, Kenneth G. Goad, Thomas M. Spitznagel, "Lyophilization cycle development for a high-concentration monoclonal antibody formulation lacking a crystalline bulking agent", Journal of Pharmaceutical Sciences, American Chemical Society and American Pharmaceutical Association, (20070601), vol. 96, no. 6, doi:10.1002/jps.20812, ISSN 00223549, pages 1598 - 1608, XP055083354
OPPOSITION- Richard J. Bellows, C.Judson King, "Freeze-drying of aqueous solutions: Maximum allowable operating temperature", Cryobiology, Academic Press, (19721201), vol. 9, no. 6, doi:10.1016/0011-2240(72)90179-4, ISSN 00112240, pages 559 - 561, XP055212212
OPPOSITION- Jiang, S. Nail, S.L., "Effect of process conditions on recovery of protein activity after freezing and freeze-drying", European journal of pharmaceutics and biopharmaceutics, ELSEVIER SCIENCE PUBLISHERS B.V., AMSTERDAM., NL, NL , (19980501), vol. 45, no. 3, doi:10.1016/S0939-6411(98)00007-1, ISSN 0939-6411, pages 249 - 257, XP004256979
OPPOSITION- Lu Xiaofeng, Pikal Michael J., "Freeze‐Drying of Mannitol-Trehalose-Sodium Chloride‐Based Formulations: The Impact of Annealing on Dry Layer Resistance to Mass Transfer and Cake Structure", PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY, NEW YORK, NY, US, US , (20040101), vol. 9, no. 1, doi:10.1081/PDT-120027421, ISSN 1083-7450, pages 85 - 95, XP009558265
SEARCH- RICHARD J. BELLOWS ET AL, "Freeze-drying of aqueous solutions: Maximum allowable operating temperature", CRYOBIOLOGY, (19721201), vol. 9, no. 6, doi:10.1016/0011-2240(72)90179-4, ISSN 0011-2240, pages 559 - 561, XP055212212 [AD] 1-21 * page 559, column 1 *

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