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Method For Producing Fusion Protein Having Igg Fc Domain - EP3363811

The patent EP3363811 was granted to Alteogen on Apr 19, 2023. The application was originally filed on Oct 14, 2016 under application number EP16855776A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3363811

ALTEOGEN
Application Number
EP16855776A
Filing Date
Oct 14, 2016
Status
Granted And Under Opposition
Mar 17, 2023
Grant Date
Apr 19, 2023
External Links
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Patent Oppositions (4)

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BOGUTZKIJan 18, 2024KLUNKER PATENTANWALTE PARTG MBBADMISSIBLE
BOULT WADE TENNANTJan 18, 2024BOULT WADE TENNANTADMISSIBLE
JAMES POOLEJan 18, 2024CARPMAELS & RANSFORDADMISSIBLE
WUESTHOFF & WUESTHOFF PATENTANWALTE PARTG MBBJan 17, 2024WICHMANNADMISSIBLE

Patent Citations (33) New

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

Citation PhasePublication NumberPublication Link
EXAMINATIONCN103319610B
EXAMINATIONWO0075319
EXAMINATIONWO03020906
EXAMINATIONWO2004058800
EXAMINATIONWO2011134919
EXAMINATIONWO2014144198
EXAMINATIONWO2015149708
INTERNATIONAL-SEARCH-REPORTJP2012520661
INTERNATIONAL-SEARCH-REPORTJP2012525415
INTERNATIONAL-SEARCH-REPORTKR20140132016
INTERNATIONAL-SEARCH-REPORTUS9090867
OPPOSITIONCN103319610
OPPOSITIONEP3363811
OPPOSITIONJP2003501089
OPPOSITIONUS11414476
OPPOSITIONUS2014296489
OPPOSITIONWO0075319
OPPOSITIONWO03020906
OPPOSITIONWO2004058800
OPPOSITIONWO2008131374
OPPOSITIONWO2009023562
OPPOSITIONWO2014006113
OPPOSITIONWO2014020160
OPPOSITIONWO2014144198
OPPOSITIONWO2015116315
OPPOSITIONWO2015149708
OPPOSITIONWO2017189679
OTHERCN103319610
OTHERWO0075319
OTHERWO03020906
OTHERWO2004058800
OTHERWO2011134919
OTHERWO2015149708

Non-Patent Literature (NPL) Citations (63) 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- Marie M. Zhu ET AL, "Chapter 32 - Industrial Production of Therapeutic Proteins: Cell Lines, Cell Culture, and Purification", Kent and Riegel's Handbook of Industrial Chemistry and Biotechnology, (20070101), pages 1421 - 1448, XP055640979-
EXAMINATION- EVELYN TRUMMER ET AL, "Process parameter shifting: Part II. Biphasic cultivation - A tool for enhancing the volumetric productivity of batch processes using Epo-Fc expressing CHO cells", BIOTECHNOLOGY AND BIOENGINEERING, WILEY, US, vol. 94, no. 6, doi:10.1002/BIT.20958, ISSN 0006-3592, (20060820), pages 1045 - 1052, (20060530), XP002651719
EXAMINATION- YUSUF B. JOHARI ET AL, "Integrated cell and process engineering for improved transient production of a "difficult-to-express" fusion protein by CHO cells : Improving Difficult-to-Express Protein Production", BIOTECHNOLOGY AND BIOENGINEERING, US, (20151201), vol. 112, no. 12, doi:10.1002/bit.25687, ISSN 0006-3592, pages 2527 - 2542, XP055640971
EXAMINATION- HU DONGDONG ET AL, "Understanding the intracellular effects of yeast extract on the enhancement of Fc-fusion protein production in Chinese hamster ovary cell culture", APPLIED MICROBIOLOGY AND BIOTECHNOLOGY, SPRINGER BERLIN HEIDELBERG, BERLIN/HEIDELBERG, vol. 99, no. 20, doi:10.1007/S00253-015-6789-5, ISSN 0175-7598, (20150711), pages 8429 - 8440, (20150711), XP035547320
EXAMINATION- MING SHI ET AL, "Controlled Growth of Chinese Hamster Ovary Cells and High Expression of Antibody-IL-2 Fusion Proteins by Temperature Manipulation", BIOTECHNOLOGY LETTERS, SPRINGER NETHERLANDS, DORDRECHT, (20051201), vol. 27, no. 23-24, doi:10.1007/S10529-005-3897-9, ISSN 1573-6776, pages 1879 - 1884, XP019231060
EXAMINATION- NIRAJ KUMAR ET AL, "Proliferation control strategies to improve productivity and survival during CHO based production culture; A summary of recent methods employed and the effects of proliferation control in product secreting CHO cell lines", CYTOTECHNOLOGY, KLUWER ACADEMIC PUBLISHERS, DO, (20070301), vol. 53, no. 1-3, doi:10.1007/S10616-007-9047-6, ISSN 1573-0778, pages 33 - 46, XP019499816
EXAMINATION- TIAN-CI KOU ET AL, "Detailed understanding of enhanced specific productivity in Chinese hamster ovary cells at low culture temperature", JOURNAL OF BIOSCIENCE AND BIOENGINEERING, ELSEVIER, AMSTERDAM, NL, vol. 111, no. 3, doi:10.1016/J.JBIOSC.2010.11.016, ISSN 1389-1723, (20101120), pages 365 - 369, (20101201), XP028149108
EXAMINATION- SARAH WULHFARD ET AL, "Mild hypothermia improves transient gene expression yields several fold in Chinese hamster ovary cells", BIOTECHNOLOGY PROGRESS, AMERICAN CHEMICAL SOCIETY, vol. 24, doi:10.1021/BP070286C, ISSN 8756-7938, (20080101), pages 458 - 465, (20080126), XP008163750
EXAMINATION- HENDRICK V ET AL, "Increased productivity of recombinant tissular plasminogen activator (t-PA) by butyrate and shift of temperature: a cell cycle phases analysis", CYTOTECHNOLOGY, KLUWER ACADEMIC PUBLISHERS, DO, (20010701), vol. 36, no. 1-3, doi:10.1023/A:1014088919546, ISSN 1573-0778, pages 71 - 83, XP019236697
INTERNATIONAL-SEARCH-REPORT- TSENG et al., "A Fusion Protein Composed of Receptor Binding Domain of Vascular Endothelial Growth Factor-A and Constant Region Fragment of Antibody: Angiogenesis Antagonistic Activity", Cytotechnology, (20110000), vol. 63, pages 285 - 293, XP055376195 [A] 1-21 * See the entire document. *
INTERNATIONAL-SEARCH-REPORT- CHAKRABARTI et al., "Studies to Prevent Degradation of Recombinant Fc-fusion Protein Expressed in Mammalian Cell Line and Protein Characterization", International Journal of Molecular Sciences, (20160609), vol. 17, no. 913, pages 1 - 22, XP055376196 [XP] 1-21 * See the entire document. *
OPPOSITION- "Aflibercept", Drugbank, Database accession no. DB08885-
OPPOSITION- Chamow, Steven M.; Ryll, Thomas; Lowman, Henry B.; Farson, Deborah, Therapeutic Fc-Fusion Proteins, Wiley, (2014), page 400pp-
OPPOSITION- "Chapter 27.2.4.3 - Recombinant Protein Production: Quantity and Quality", Michael C. Flickinger, Upstream Industrial Biotechnology - Expression Systems and Process Development, (20130101), XP093154636-
OPPOSITION- KAUFMANN H ET AL, "Influence of low temperature on productivity, proteome and protein phosphorylation of CHO cells.", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (19990605), vol. 63, no. 5, ISSN 0006-3592, pages 573 - 582, XP002580113-
OPPOSITION- Li Fan ; Liang Zhao ; Zhaoyang Ye ; Yating Sun ; Tianci Kou ; Yan Zhou ; Wen-Song Tan, "Effect of culture temperature on TNFR-Fc productivity in recombinant glutamine synthetase-chinese hamster ovary cells", Biotechnology Letters, Springer Netherlands, Dordrecht, Dordrecht , (20100609), vol. 32, no. 9, ISSN 1573-6776, pages 1239 - 1244, XP019813500-
OPPOSITION- Marie M. Zhu, Michael Mollet And Rene S. Hubert, "Chapter 32 - Industrial Production of Therapeutic Proteins: Cell Lines, Cell Culture, and Purification", Kent and Riegel's Handbook of Industrial Chemistry and Biotechnology, (20070101), pages 1421 - 1448, XP055640979-
OPPOSITION- Marie M. Zhu, Michael Mollet And Rene S. Hubert, "Chapter 32 - Industrial Production of Therapeutic Proteins: Cell Lines, Cell Culture, and Purification", Marie M. Zhu, Michael Mollet And Rene S. Hubert, James A. Kent, Kent and Riegel's Handbook of Industrial Chemistry and Biotechnology, (20070101), pages 1421 - 1448, XP055640979-
OPPOSITION- Q. Ashton Acton, Advances in Cell Line Research and Application, (20120101), page 24, 25, 30, 31, XP093154634-
OPPOSITION- Steven M Chamow, "Chapters 3.3 to 3.5", Therapeutic Fc-Fusion Proteins, Wiley Blackwell, (20140101), pages 77 - 96, ISBN 978-3-527-33317-2, XP093158204-
OPPOSITION- Vázquez-Rey and Lang, 2011, Biotech. Bioeng., 108:1494-1508-
OPPOSITION- Wei Wang, Christopher J. Roberts, Aggregation of Therapeutic Proteins passage, US , Wiley , (20100901), pages 270 - 271, ISBN 978-0-470-41196-4, XP007922430-
OPPOSITION- World Health Organisation, "International Nonproprietary Names for Pharmaceutical Substances (INN) - aflibercept entry", WHO Drug Information, (20060101), vol. 20, no. 2, pages 115 - 162, XP093156780-
OPPOSITION- Zhu, 2012, Biotech. Adv. 30:1158-1170-
OPPOSITION- Evelyn Trummer; Katharina Fauland; Silke Seidinger; Kornelia Schriebl; Christine Lattenmayer; Renate Kunert; Karola Vorauer‐Uhl; Robert Weik; Nicole Borth; Hermann Katinger; Dethardt Müller, "Process parameter shifting: Part II. Biphasic cultivation—A tool for enhancing the volumetric productivity of batch processes using Epo‐Fc expressing CHO cells", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20060530), vol. 94, no. 6, doi:10.1002/bit.20958, ISSN 0006-3592, pages 1045 - 1052, XP071052209
OPPOSITION- Evelyn Trummer, Katharina Fauland, Silke Seidinger, Kornelia Schriebl, Christine Lattenmayer, Renate Kunert, Karola Vorauer-Uhl, Robert Weik, Nicole Borth, Hermann Katinger, Dethardt Müller, "Process parameter shifting: Part II. Biphasic cultivation - A tool for enhancing the volumetric productivity of batch processes using Epo-Fc expressing CHO cells", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20060820), vol. 94, no. 6, doi:10.1002/BIT.20958, ISSN 0006-3592, pages 1045 - 1052, XP002651719
OPPOSITION- Evelyn Trummer; Katharina Fauland; Silke Seidinger; Kornelia Schriebl; Christine Lattenmayer; Renate Kunert; Karola Vorauer‐Uhl; Robert Weik; Nicole Borth; Hermann Katinger; Dethardt Müller, "Process parameter shifting: Part I. Effect of DOT, pH, and temperature on the performance of Epo‐Fc expressing CHO cells cultivated in controlled batch bioreactors", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20060530), vol. 94, no. 6, doi:10.1002/bit.21013, ISSN 0006-3592, pages 1033 - 1044, XP071052206
OPPOSITION- TRUMMER EVELYN ET AL, "Process parameter shifting: Part I. Effect of DOT, pH, and temperature on the performance of Epo-Fc expressing CHO cells cultivated in controlled batch bioreactors.", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20060820), vol. 94, no. 6, doi:10.1002/bit.21013, ISSN 0006-3592, pages 1033 - 1044, XP002486305
OPPOSITION- Yusuf B. Johari; Scott D. Estes; Christina S. Alves; Marty S. Sinacore; David C. James, "Integrated cell and process engineering for improved transient production of a “difficult‐to‐express“ fusion protein by CHO cells", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20150907), vol. 112, no. 12, doi:10.1002/bit.25687, ISSN 0006-3592, pages 2527 - 2542, XP071155179
OPPOSITION- Yusuf B. Johari, Scott D. Estes, Christina S. Alves, Marty S. Sinacore, David C. James, "Integrated cell and process engineering for improved transient production of a "difficult-to-express" fusion protein by CHO cells : Improving Difficult-to-Express Protein Production", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20151201), vol. 112, no. 12, doi:10.1002/bit.25687, ISSN 0006-3592, pages 2527 - 2542, XP055640971
OPPOSITION- KAUFMANN HITTO, ET AL, "Influence of low temperature on productivity, proteome and protein phosphorylation of CHO cells", BIOTECHNOLOGY AND BIOENGINEERING - COMBINATORIAL CHEMISTRY., WILEY, NEW YORK, NY., US, US , (19990605), vol. 63, no. 5, doi:10.1002/(SICI)1097-0290(19990605)63:5<573::AID-BIT7>3.0.CO;2-Y, pages 573 - 582, XP002389455
OPPOSITION- Marie M. Zhu, "Industrial Production of Therapeutic Proteins: Cell Lines, Cell Culture, and Purification", Kent and Riegel's Handbook of Industrial Chemistry and Biotechnology, Eleventh Edition, Cham, Springer Science+Business Media, LLC., (20170503), pages 1421 - 1448, doi:10.1007/978-3-319-52287-6_29, ISBN 978-0-387-27842-1, XP093158194
OPPOSITION- Hu Dongdong; Sun Yating; Liu Xuping; Liu Jintao; Zhang Xintao; Zhao Liang; Wang Haibin; Tan Wen-Song; Fan Li, "Understanding the intracellular effects of yeast extract on the enhancement of Fc-fusion protein production in Chinese hamster ovary cell culture", Applied Microbiology and Biotechnology, Springer Berlin Heidelberg, Berlin/Heidelberg, Berlin/Heidelberg, (20150711), vol. 99, no. 20, doi:10.1007/s00253-015-6789-5, ISSN 0175-7598, pages 8429 - 8440, XP035547320
OPPOSITION- Kumar Niraj; Gammell Patrick; Clynes Martin, "Proliferation control strategies to improve productivity and survival during CHO based production culture", Cytotechnology, Springer Netherlands, Dordrecht, Dordrecht, (20070301), vol. 53, no. 1-3, doi:10.1007/s10616-007-9047-6, ISSN 0920-9069, pages 33 - 46, XP037912763
OPPOSITION- George Trichonas, "Aflibercept for the Treatment of Age-Related Macular Degeneration", Ophthalmology and Therapy, (20130625), vol. 2, no. 2, doi:10.1007/s40123-013-0015-2, ISSN 2193-8245, pages 89 - 98, XP093156774
OPPOSITION- Jianwei Zhu, "Mammalian cell protein expression for biopharmaceutical production", BIOTECHNOLOGY ADVANCES., ELSEVIER PUBLISHING, BARKING., GB, GB , (20120901), vol. 30, no. 5, doi:10.1016/j.biotechadv.2011.08.022, ISSN 0734-9750, pages 1158 - 1170, XP055276897
OPPOSITION- Tian-Ci Kou; Li Fan; Yan Zhou; Zhao-Yang Ye; Xu-Ping Liu; Liang Zhao; Wen-Song Tan;, "Detailed understanding of enhanced specific productivity in Chinese hamster ovary cells at low culture temperature", Journal of bioscience and bioengineering, ELSEVIER, AMSTERDAM, NL, NL , (20101120), vol. 111, no. 3, doi:10.1016/j.jbiosc.2010.11.016, ISSN 1389-1723, pages 365 - 369, XP028149108
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OPPOSITION- Kim, S. Mohamedali, K.A. Cheung, L.H. Rosenblum, M.G., "Overexpression of biologically active VEGF"1"2"1 fusion proteins in Escherichia coli", Journal of Biotechnology, Elsevier, Amsterdam NL, Amsterdam NL , (20070124), vol. 128, no. 3, doi:10.1016/j.jbiotec.2006.11.027, ISSN 0168-1656, pages 638 - 647, XP005856759
OPPOSITION- Christian Kaisermayer et al., "Biphasic cultivation strategy to avoid Epo-Fc aggregation and optimize protein expression", Journal of Biotechnology, (2016), vol. 227, doi:10.1016/j.jbiotec.2016.03.054, XP093082164
OPPOSITION- Kaisermayer Christian, Reinhart David, Gili Andreas, Chang Martina, Aberg Per-Mikael, Castan Andreas, Kunert Renate, "Biphasic cultivation strategy to avoid Epo-Fc aggregation and optimize protein expression", Journal of Biotechnology, Elsevier, Amsterdam NL, Amsterdam NL , (20160601), vol. 227, doi:10.1016/j.jbiotec.2016.03.054, ISSN 0168-1656, pages 3 - 9, XP093082164
OPPOSITION- J. Rodriguez; M. Spearman; N. Huzel; M. Butler, "Enhanced Production of Monomeric Interferon‐β by CHO Cells through the Control of Culture Conditions", Biotechnology Progress, American Chemical Society, Hoboken, USA, Hoboken, USA, (20080905), vol. 21, no. 1, doi:10.1021/bp049807b, ISSN 8756-7938, pages 22 - 30, XP072298558
OPPOSITION- J Rodriguez et al., "Enhanced Production of Monomeric Interferon-B by CHO Cells through the Control of Culture Conditions", Biotehcnol. Prog., (2005), vol. 21, doi:10.1021/BP049807B, XP002572995
OPPOSITION- Kazuaki Furukawa et al., "Enhancement of productivity of recombinant alpha-amidating enzyme by low temperature culture", Cytotechnology, (1999), vol. 31, doi:10.1023/A:1008059803038, XP019236635
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OPPOSITION- Cromwell Mary E.; Hilario Eric; Jacobson Fred, "Protein aggregation and bioprocessing", The AAPS Journal, Springer New York, New York, New York , (20060901), vol. 8, no. 3, doi:10.1208/aapsj080366, pages E572 - E579, XP036197987
OPPOSITION- Sanjukta Chakrabarti, Et Al, "Studies to Prevent Degradation of Recombinant Fc-Fusion Protein Expressed in Mammalian Cell Line and Protein Characterization", International Journal of Molecular Sciences, (20160609), vol. 17, no. 6, doi:10.3390/ijms17060913, pages 1 - 22, XP055376196
OPPOSITION- Sanjukta Chakrabarti, Et Al, "Studies to Prevent Degradation of Recombinant Fc-Fusion Protein Expressed in Mammalian Cell Line and Protein Characterization", International Journal of Molecular Sciences, vol. 17, no. 6, doi:10.3390/ijms17060913, pages 1 - 22, XP055376196
OTHER- FAN et al., "Effect of culture temperature on TNFR-Fc productivity in recombinant glutamine synthetase-chinese hamster ovary cells", Biotechnol Lett, (20100000), vol. 32, pages 1239 - 1244, XP019813500-
OTHER- Zhu et al., "Chapter 32 - Industrial Production of Therapeutic Proteins: Cell Lines, Cell Culture, and Purification", Kent and Riegel's Handbook of Industrial Chemistry and Biotechnology, (2007), pages 1421 - 1448, XP055640979-
OTHER- TRUMMER et al., "Process parameter shifting: Part II. Biphasic cultivation - A tool for enhancing the volumetric productivity of batch processes using Epo-Fc expressing CHO cells", Biotechnology and Bioengineering, (20060000), vol. 94, no. 6, pages 1045 - 1052, XP002651719
OTHER- JOHARI et al., "Integrated cell and process engineering for improved transient production of a “difficult-to-express“ fusion protein by CHO cells", Biotechnology and Bioengineering, (20150000), vol. 112, no. 12, pages 2527 - 2542, XP055640971
OTHER- HU et al., "Understanding the intracellular effects of yeast extract on the enhancement of Fc-fusion protein production in Chinese hamster ovary cell culture", Applied Microbiology and Biotechnology, (20150000), vol. 99, pages 8429 - 8440, XP035547320
OTHER- SHI et al., "Controlled Growth of Chinese Hamster Ovary Cells and High Expression of Antibody-IL-2 Fusion Proteins by Temperature Manipulation", Biotechnology Letters, (20050000), vol. 27, pages 1879 - 1884, XP019231060
OTHER- KUMAR et al., "Proliferation control strategies to improve productivity and survival during CHO based production culture; A summary of recent methods employed and the effects of proliferation control in product secreting CHO cell lines", Cytotechnology, (20070000), vol. 53, pages 33 - 46, XP019499816
OTHER- KOU et al., "Detailed understanding of enhanced specific productivity in Chinese hamster ovary cells at low culture temperature", Journal of Bioscience and Bioengineering, (20110000), vol. 111, no. 3, pages 365 - 369, XP028149108
OTHER- WULHFARD et al., "Mild hypothermia improves transient gene expression yields several fold in Chinese hamster ovary cells", Biotechnol Prog, (20080000), vol. 24, pages 458 - 465, XP008163750
OTHER- HENDRICK et al., "Increased productivity of recombinant tissular plasminogen activator (t-PA) by butyrate and shift of temperature: a cell cycle phases analysis", Cytotechnology, (20010000), vol. 36, pages 71 - 83, XP019236697
SEARCH- EVELYN TRUMMER ET AL, "Process parameter shifting: Part I. Effect of DOT, pH, and temperature on the performance of Epo-Fc expressing CHO cells cultivated in controlled batch bioreactors", BIOTECHNOLOGY AND BIOENGINEERING, US, (20060101), vol. 94, no. 6, doi:10.1002/bit.21013, ISSN 0006-3592, pages 1033 - 1044, XP055544852 [X] 16-21 * page 1037, column 1, paragraph 2 - paragraph l * * page 1041, column 2, paragraph 3 - page 1043, column 1, paragraph 2; table 1 * [Y] 1-15
SEARCH- MARIA VAZQUEZ-REY ET AL, "Aggregates in monoclonal antibody manufacturing processes", BIOTECHNOLOGY AND BIOENGINEERING, US, (20110420), vol. 108, no. 7, doi:10.1002/bit.23155, ISSN 0006-3592, pages 1494 - 1508, XP055365984 [Y] 1-15 * page 1497, column 2, paragraph 3 - page 1498, column 1, paragraph 2 *
SEARCH- JIANWEI ZHU, "Mammalian cell protein expression for biopharmaceutical production", BIOTECHNOLOGY ADVANCES., GB, (20120901), vol. 30, no. 5, doi:10.1016/j.biotechadv.2011.08.022, ISSN 0734-9750, pages 1158 - 1170, XP055276897 [X] 16-21 * page 1164, column 1, paragraph 1 - paragraph 2 * * page 1167, column 1, paragraph 3 * [Y] 1-15
SEARCH- D.J. GALBRAITH ET AL, "Control of Culture Environment for Improved Polyethylenimine-Mediated Transient Production of Recombinant Monoclonal Antibodies by CHO Cells", BIOTECHNOLOGY PROGRESS, (20060602), vol. 22, no. 3, doi:10.1021/bp050339v, ISSN 8756-7938, pages 753 - 762, XP055544807 [X] 16-21 * page 756, column 2, paragraph 4 - page 758, column 1, paragraph 3; figure 3C * [Y] 1-15

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