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A Method For Controlling The Main Complex N-Glycan Structures And The Acidic Variants And Variability In Bioprocesses Producing Recombinant Proteins - EP2697251

The patent EP2697251 was granted to LEK Pharmaceuticals DD on Feb 27, 2019. The application was originally filed on Apr 12, 2012 under application number EP12713737A. The patent is currently recorded with a legal status of "Revoked".

EP2697251

LEK PHARMACEUTICALS DD
Application Number
EP12713737A
Filing Date
Apr 12, 2012
Status
Revoked
Apr 10, 2024
Grant Date
Feb 27, 2019
External Links
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Patent Oppositions (2)

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HOFFMANN EITLENov 27, 2019HOFFMANN EITLEADMISSIBLE
PATENTANWALTE ISENBRUCK BOSL HORSCHLER PARTG MBBNov 26, 2019SIMMONS & SIMMONS MUNICHADMISSIBLE

Patent Citations (14) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONUS2003204862
DESCRIPTIONUS5223409
DESCRIPTIONUS5859205
DESCRIPTIONUS6248516
DESCRIPTIONUS6300064
DESCRIPTIONUS6331415
DESCRIPTIONUS6548640
EXAMINATIONWO9512684
INTERNATIONAL-SEARCH-REPORTUS6338964
OPPOSITIONUS6338964
OPPOSITIONWO2008128227
OPPOSITIONWO2009086309
OPPOSITIONWO2010017338
OPPOSITIONWO9512684

Non-Patent Literature (NPL) Citations (26) 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- LIPSCOMB ML; PALOMARES LA; HERNANDEZ V; RAMIREZ OT; KOMPALA DS, "Effect of production method and gene amplification on the glycosylation pattern of a secreted reporter protein in CHO cells", BIOTECHNOL PROG., (2005), vol. 21, pages 40 - 49-
DESCRIPTION- TRUMMER E; FAULAND K; SEIDINGER S; SCHRIEBL K; LATTENMAYER C; KUNERT R; VORAUER-UHL K; WEIK R; BORTH N; KATINGER H, "Process parameter shifting: Part II. Biphasic cultivation-A tool for enhancing the volumetric productivity of batch processes using Epo-Fc expressing CHO cells", BIOTECHNOL BIOENG., (2006), vol. 94, doi:doi:10.1002/BIT.20958, pages 1045 - 1052, XP002651719
DESCRIPTION- TAKUMA S; HIRASHIMA C; PIRET JM, "Dependence on glucose limitation of the pC02 influences on CHO cell growth, metabolism and IgG production", BIOTECHNOL BIOENG., (2007), vol. 97, doi:doi:10.1002/bit.21376, pages 1479 - 1488, XP002537214
DESCRIPTION- ZANGHI JA; SCHMELZER AE; MENDOZA TP; KNOP RH; MILLER WM, "Bicarbonate concentration and osmolality are key determinants in the inhibition of CHO cell polysialylation under elevated pCO(2) or pH", BIOTECHNOL BIOENG., (1999), vol. 65, doi:doi:10.1002/(SICI)1097-0290(19991020)65:2<182::AID-BIT8>3.0.CO;2-D, pages 182 - 191, XP002651718
DESCRIPTION- BUTLER M., "Optimisation of the cellular metabolism of glycosylation for recombinant proteins produced by mammalian cell systems", CYTOTECHNOLOGY, (2006), vol. 50, doi:doi:10.1007/s10616-005-4537-x, pages 57 - 76, XP019393897
EXAMINATION- JEFFERIS ROY, "Glycosylation as a strategy to improve antibody-based therapeutics", NATURE REVIEWS. DRUG DISCOVERY, NATURE PUBLISHING GROUP, GB, (20090301), vol. 8, no. 3, doi:10.1038/NRD2804, ISSN 1474-1784, pages 226 - 234, XP002600969
INTERNATIONAL-SEARCH-REPORT- TRUMMER E 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 20060820 JOHN WILEY AND SONS INC. US, (20060820), vol. 94, no. 6, doi:DOI:10.1002/BIT.20958, pages 1045 - 1052, XP002651719 [A] 1-15 * Page 1049. left column; Discussion *
INTERNATIONAL-SEARCH-REPORT- TAKUMA SHINYA ET AL, "Dependence on glucose limitation of the pCO(2) influences on CHO cell growth, metabolism and IgG production", BIOTECHNOLOGY AND BIOENGINEERING, WILEY & SONS, HOBOKEN, NJ, US, (20070801), vol. 97, no. 6, doi:DOI:10.1002/BIT.21376, ISSN 0006-3592, pages 1479 - 1488, XP002537214 [A] 1-15 * Page 1485 Effects of pCO2 and conclusion *
INTERNATIONAL-SEARCH-REPORT- ZANGHI J A ET AL, "Bicarbonate concentration and osmolality are key determinants in the inhibition of CHO cell polysialylation under elevated pCO2 or pH", BIOTECHNOLOGY AND BIOENGINEERING 19991020 JOHN WILEY AND SONS INC. US, (19991020), vol. 65, no. 2, doi:DOI:10.1002/(SICI)1097-0290(19991020)65:2<182::AID-BIT8>3.0.CO;2-D, pages 182 - 191, XP002651718 [A] 1-15 * Discussion *
INTERNATIONAL-SEARCH-REPORT- SCHMELZER A E ET AL, Hyperosmotic stress and elevated pCO2 alter monoclonal antibody charge distribution and monosaccharide content, BIOTECHNOLOGY PROGRESS 2002 AMERICAN CHEMICAL SOCIETY US, VOL. 18, NR. 2, PAGE(S) 346 - 353, (2002), XP002651720 [A] 1-15 * Cell culture on page 347, Monosaccharide analysis on page 348 and Discussion *
INTERNATIONAL-SEARCH-REPORT- ZHU M M ET AL, "Effects of elevated pCO2 and osmolality on growth of CHO cells and production of antibody-fusion protein B1: A case study", BIOTECHNOLOGY PROGRESS JANUARY/FEBRUARY 2005 AMERICAN CHEMICAL SOCIETY US, (200501), vol. 21, no. 1, doi:DOI:10.1021/BP049815S, pages 70 - 77, XP002651721 [A] 1-15 * Introduction and conclusion *
OPPOSITION- J. MUTHING et al., "Effects of Buffering Conditions and Culture pH on Production Rates and Glycosylation of Clinical Phase I Anti-melanoma Mouse IgG3 Monoclonal Antibody R24", Biotechnol. Bioeng., (20030000), vol. 83, no. 3, pages 321 - 334, XP002576592-
OPPOSITION- M. GAWLITZEK et al., "Ammonium Alters N-Glycan Structures of Recombinant TNFR-IgG: Degradative Versus Biosynthetic Mechanisms", Biotechnol. Bioeng ., (20000000), vol. 68, no. 6, pages 637 - 646, XP008079772-
OPPOSITION- E. 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", Biotechnol. Bioeng., (20060000), vol. 94, no. 6, doi:10.1002/BIT.20958, pages 1045 - 1052, XP002651719
OPPOSITION- S. TAKUMA et al., "Dependence on Glucose Limitation of the pC02 Influences on CHO Cell Growth, Metabolism and IgG Production", Biotechnol. Bioeng., (20070000), vol. 97, no. 6, doi:10.1002/bit.21376, pages 1479 - 1488, XP002537214
OPPOSITION- TAKUMA et al., "Dependence on glucose limitation of the pCO(2) influences on CHO cell growth, metabolism and IgG production", Biotechnol. Bioeng., (20070000), vol. 97, pages 1479 - 1488, XP002537214
OPPOSITION- M.J.GRAMER et al., "Modulation of Antibody Galactosylation Through Feeding of Uridine, Manganes Chloride, and Galactose", Biotechnol. Bioeng., vol. 108, no. 7, (20110215), pages 1591 - 1601, XP002688515
OPPOSITION- I. JIMENEZ DEL VAL et al., "Towards the Implementation of Quality by Design to the Production of Therapeutic Monoclonal Antibodies with Desired Glycosylation Patterns", Biotechnol. Prog., (20100000), vol. 26, no. 6, doi:10.1002/btpr.470, pages 1505 - 1527, XP055615705
OPPOSITION- A. ZANGHI et al., "Bicarbonate Concentration and Osmolality Are Key Determinants in the Inhibition of CHO Cell Polysialylation Under Elevated pC02 or pH", Biotechnol. Bioeng., (19990000), vol. 65, no. 2, doi:10.1002/(SICI)1097-0290(19991020)65:2<182::AID-BIT8>3.0.CO;2-D, pages 182 - 191, XP002651718
OPPOSITION- ZANGHI et al., ""Bicarbonate concentration and osmolality are key determinants in the inhibition of CHO cell polysialylation under elevated pCO2 or pH", Biotechnol. Bioeng., (19990000), vol. 65, pages 182 - 191, XP002651718
OPPOSITION- A. E. SCHMELZER et al., "Hyperosmotic Stress and Elevated pCO2 Alter Monoclonal Antibody Charge Distribution and Monosaccharide Content", Biotechnol. Prog., (20020000), vol. 18, doi:10.1021/BP010187D, pages 346 - 353, XP002651720
OPPOSITION- SCHMELZER et al., "Hyperosmotic Stress and Elevated pCO2 Alter Monoclonal Antibody Charge Distribution and Monosaccharide Content", Biotechnol. Prog., (20020000), vol. 18, pages 346 - 353, XP002651720
OPPOSITION- ZHU et al., "Effects of elevated pCO2 and osmolality on growth of CHO cells and production of antibody-fusion protein B1: A case study", Biotechnol. Prog., (20050000), vol. 21, pages 70 - 77, XP002651721
OPPOSITION- HOSSLER et al., "Optimal and consistent protein glycosylation in mammalian cell culture", Glycobiology, (20090000), vol. 19, pages 936 - 949, XP055112498
OPPOSITION- P. HOSSLER et al., "Optimal and consistent protein glycosylation in mammalian cell culture", Glycobiology, (20090000), vol. 19, no. 9, doi:10.1093/glycob/cwp079, pages 936 - 949, XP055112498
OPPOSITION- LI et al., "Cell culture processes for monoclonal antibody production", mAbs, (20100000), vol. 2, pages 466 - 477, XP055166177

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