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Control Of Trace Metals During Production Of Anti-Cd38 Antibodies - EP3880824

The patent EP3880824 was granted to Janssen Biotech on Jul 24, 2024. The application was originally filed on Nov 13, 2019 under application number EP19885702A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3880824

JANSSEN BIOTECH
Application Number
EP19885702A
Filing Date
Nov 13, 2019
Status
Granted And Under Opposition
Jun 20, 2024
Grant Date
Jul 24, 2024
External Links
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DEHMEL & BETTENHAUSEN PATENTANWALTE PARTMBBApr 24, 2025RUCKERLADMISSIBLE

Patent Citations (44) New

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

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OPPOSITIONWO2008008360
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SEARCHWO2015130728

Non-Patent Literature (NPL) Citations (16) 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
OPPOSITION- Anonymous, "Darzalex (daratumumab)/Injection (761036Orig1s000)", Chemistry Review, FDA, (20151022), pages 1 - 74, Chemistry Review, URL: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/761036Orig1s000ChemR.pdf, XP093273145-
OPPOSITION- Anonymous, "International Nonproprietary Names for Pharmaceutical Substances (INN)", WHO Drug Information, (20090101), vol. 23, no. 2, pages 129 - 192, XP055858023-
OPPOSITION- D15 - Report on the Deliberation Results (English Version) of the Pharmaceutical Evaluation Division of the Japanese Pharmaceutical Safety and Environmental Health Bureau Ministry of Health, Labour and Welfare, Approval of Darzalex, 12 September 2017-
OPPOSITION- Wilson Scott, Barry Drew, Joanna Grayham, And Chandana Sharma, "Raw Material Characterization: Effect of Trace Metal Variability on Protein Glycosylation", SAFC White paper, Sigma-Aldrich, (20150610), pages 1 - 1, SAFC White paper, URL: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/420/281/effect-of-trace-metal-variability-on-protein-glycosylation.pdf, XP093273136-
OPPOSITION- Michael J. Gramer; Jackie J. Eckblad; Ruth Donahue; Joseph Brown; Carrie Shultz; Kent Vickerman; Patrick Priem; Ewald T.J. van den Bremer; Jolanda Gerritsen; Patrick H.C. van Berkel, "Modulation of antibody galactosylation through feeding of uridine, manganese chloride, and galactose", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20110218), vol. 108, no. 7, doi:10.1002/bit.23075, ISSN 0006-3592, pages 1591 - 1602, XP071113776
OPPOSITION- Rhian K. Grainger; David C. James, "CHO cell line specific prediction and control of recombinant monoclonal antibody N‐glycosylation", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20130606), vol. 110, no. 11, doi:10.1002/bit.24959, ISSN 0006-3592, pages 2970 - 2983, XP071145936
OPPOSITION- Ryan J. Graham, Hemlata Bhatia, Seongkyu Yoon, "Consequences of trace metal variability and supplementation on Chinese hamster ovary (CHO) cell culture performance: A review of key mechanisms and considerations", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20191201), vol. 116, no. 12, doi:10.1002/bit.27140, ISSN 0006-3592, pages 3446 - 3456, XP055767101
OPPOSITION- Jenna Williamson; Jennifer Miller; Joseph McLaughlin; Rodney Combs; Chia Chu, "Scale‐dependent manganese leaching from stainless steel impacts terminal galactosylation in monoclonal antibodies", Biotechnology Progress, American Chemical Society, Hoboken, USA, Hoboken, USA, (20180806), vol. 34, no. 5, doi:10.1002/btpr.2662, ISSN 8756-7938, pages 1290 - 1297, XP072295339
OPPOSITION- Patrick H. C. van Berkel; Jolanda Gerritsen; Gerrard Perdok; Jesper Valbjørn; Tom Vink; Jan G. J. van de Winkel; Paul W. H. I. Parren, "N‐linked glycosylation is an important parameter for optimal selection of cell lines producing biopharmaceutical human IgG", Biotechnology Progress, American Chemical Society, Hoboken, USA, Hoboken, USA, (20090113), vol. 25, no. 1, doi:10.1002/btpr.92, ISSN 8756-7938, pages 244 - 251, XP072296059
OPPOSITION- T. Shantha Raju, Robert E. Jordan, "Galactosylation variations in marketed therapeutic antibodies", mAbs, (20120501), vol. 4, no. 3, doi:10.4161/mabs.19868, ISSN 19420862, pages 385 - 391, XP055138140
SEARCH- MICHAEL J GRAMER ET AL, "Modulation of antibody galactosylation through feeding of uridine, manganese chloride, and galactose", BIOTECHNOLOGY AND BIOENGINEERING, JOHN WILEY, HOBOKEN, USA, (20110218), vol. 108, no. 7, doi:10.1002/BIT.23075, ISSN 0006-3592, pages 1591 - 1602, XP071113776 [Y] 1-15 * the whole document *
SEARCH- EFREN PACIS ET AL, "Effects of cell culture conditions on antibody N-linked glycosylation-what affects high mannose 5 glycoform", BIOTECHNOLOGY AND BIOENGINEERING, JOHN WILEY, HOBOKEN, USA, (20110524), vol. 108, no. 10, doi:10.1002/BIT.23200, ISSN 0006-3592, pages 2348 - 2358, XP071115329 [A] 1-15 * the whole document *
SEARCH- MELISSA M ST AMAND ET AL, "Identification of manipulated variables for a glycosylation control strategy", BIOTECHNOLOGY AND BIOENGINEERING, JOHN WILEY, HOBOKEN, USA, (20140522), vol. 111, no. 10, doi:10.1002/BIT.25251, ISSN 0006-3592, pages 1957 - 1970, XP071153388 [Y] 1-15 * the whole document *
SEARCH- SURVE TANAYA ET AL, "Manganese increases high mannose glycoform on monoclonal antibody expressed in CHO when glucose is absent or limiting: Implications for use of alternate sugars", BIOTECHNOLOGY PROGRESS, (20141229), vol. 31, no. 2, doi:10.1002/btpr.2029, ISSN 8756-7938, pages 460 - 467, XP055927999 [Y] 1-15 * the whole document *
SEARCH- PRABHU ANUJA ET AL, "Nickel and cobalt affect galactosylation of recombinant IgG expressed in CHO cells", BIOMETALS, KLUWER ACADEMIC PUBLISHERS, NL, vol. 32, no. 1, doi:10.1007/S10534-018-0152-0, ISSN 0966-0844, (20181016), pages 11 - 19, (20181016), XP036691706 [A] 1-15 * the whole document *
SEARCH- RADHAKRISHNAN DEVESH ET AL, "Controlling the Glycosylation Profile in mAbs Using Time-Dependent Media Supplementation", ANTIBODIES, (20171221), vol. 7, no. 1, doi:10.3390/antib7010001, page 1, XP055928006 [Y] 1-15 * the whole document *

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