| DESCRIPTION | - APPENDIX C, Buffers for Use in Protein Chemistry | - |
| DESCRIPTION | - "Engineered antibody fragments and the rise of single domains", HOLLINGER, PHUDSON, P, Engineering Therapeutic Antibodies, (20050900), vol. 15, pages 1126 - 1136 | - |
| DESCRIPTION | - GUO et al., Electrophoresis, (20080000), vol. 29, no. 12, pages 2550 - 6 | - |
| DESCRIPTION | - KENDRICK et al., "Physical stabilization of proteins in aqueous solution", RATIONAL DESIGN OF STABLE PROTEIN FORMULATIONS: THEORY AND PRACTICE | - |
| DESCRIPTION | - LIU et al., mAbs, (20100000), vol. 2, no. 5, pages 480 - 499 | - |
| DESCRIPTION | - PROTEIN PURIFICATION PRINCIPLES AND PRACTICE, Springer-Verlag, (19940000), pages 160 - 164 | - |
| DESCRIPTION | - SHIMAMOTO, MAbs, (20120000), vol. 4, no. 5, pages 586 - 91 | - |
| DESCRIPTION | - TERRANCE G. COOPER, THE TOOLS OF BIOCHEMISTRY, John Wiley & Sons, (19770000), pages 1 - 35 | - |
| DESCRIPTION | - RANDOLPH et al., "Surfactant-protein interactions", Pharm Biotechnol, (20020000), vol. 13, doi:10.1007/978-1-4615-0557-0_7, pages 159 - 75, XP055647590 | |
| DESCRIPTION | - ARAKAWA et al., "Solvent interactions in pharmaceutical formulations", Pharm Res, (19910000), vol. 8, no. 3, doi:10.1023/A:1015825027737, pages 285 - 91, XP009052919 | |
| OPPOSITION | - 3m, "Zeta Plus®BioCap™ - Disposable Filter Capsules for the Biotechnology & Pharmaceutical Industries", CUNO Product Brochure, (20070101), pages 1 - 8, XP093195632 | - |
| OPPOSITION | - 3m, "Zeta Plus® CP & SP Series", Data Sheet, (20070101), pages 1 - 5, XP093195629 | - |
| OPPOSITION | - 3m, "Zeta Plus ZA Series - Depth Filter Cartridges & Capsules", Product Data Sheet, (20090201), pages 1 - 4, XP093195626 | - |
| OPPOSITION | - Anonymous, "11320 - DMEM/F-12", ThermoFisher, Media Formulations, ThermoFisher, Media Formulations, URL: https://www.thermofisher.com/nl/en/home/technical-resources/media-formulation.55.html, XP093191312 | - |
| OPPOSITION | - Anonymous, "3M™ Zeta Plus™ VR Series Filter Cartridge | Solventum (3M ID B40070862 )", 3M Product Description, 3M, pages 1 - 8, 3M Product Description, URL: https://www.solventum.com/en-gb/home/f/b40070862/, XP093276961 | - |
| OPPOSITION | - Anonymous, "Affinity of Protein A/G for IgG Types from Different Species", New England Biolabs table of Protein A affinity, New England Biolabs, pages 1 - 1, New England Biolabs table of Protein A affinity , URL: https://www.neb.com/en/tools-and-resources/selection-charts/affinity-of-protein-ag-for-igg-types-from-different-species, XP093276189 | - |
| OPPOSITION | - Anonymous, "BECO Depth Filter Sheets", Begerow Product Line, Eaton Corp., pages 1 - 16, Begerow Product Line, XP093276404 | - |
| OPPOSITION | - Anonymous, "Clarisolve® 20 µm Pod Depth Filters, 0.55 m2 (5.92 ft2) | CS20MS05F1-X", Merck - Biopharmaceutical Manufacturing>Downstream Processing>Clarification>Clarisolve Depth Filters>Clarisolve® Depth Filter>, Merck, pages 1 - 3, Merck - Biopharmaceutical Manufacturing>Downstream Processing>Clarification>Clarisolve Depth Filters>Clarisolve® Depth Filter>, URL: https://www.merckmillipore.com/NL/en/product/Clarisolve-20-m-Pod-Depth-Filters-0.55-m2-5.92-ft2,MM_NF-CS20MS05F1-X, XP093276412 | - |
| OPPOSITION | - Anonymous, "Clarisolve® 40 µm Pod Depth Filters, 0.11 m2 (1.18 ft2) | CS40MS01F1-X", Merck - Biopharmaceutical Manufacturing>Downstream Processing>Clarification>Clarisolve Depth Filters>Clarisolve® Depth Filter>, Merck, pages 1 - 3, Merck - Biopharmaceutical Manufacturing>Downstream Processing>Clarification>Clarisolve Depth Filters>Clarisolve® Depth Filter>, URL: https://www.merckmillipore.com/NL/en/product/Clarisolve-40-m-Pod-Depth-Filters-0.11-m2-1.18-ft2,MM_NF-CS40MS01F1-X, XP093276416 | - |
| OPPOSITION | - Anonymous, "Clarisolve® 60 µm Depth Filters in µPod® Format, 23 cm2 (0.025 ft2) | CS60HX01L3", Merck - Biopharmaceutical Manufacturing>Harvest>Clarification>Clarisolve Depth Filters, Merck, pages 1 - 4, Merck - Biopharmaceutical Manufacturing>Harvest>Clarification>Clarisolve Depth Filters, URL: https://www.merckmillipore.com/NL/en/product/Clarisolve-60-m-Depth-Filters-in-Pod-Format-23-cm2-0.025-ft2,MM_NF-CS60HX01L3, XP093276420 | - |
| OPPOSITION | - Anonymous C, Oru F, Schenerman Mark, Sunday Brooks, Kozlowski Steve, Webber Keith, Gazzano-Santoro Helene, Mire-Sluis Anthony, "Analysis and Structure Characterization of Monoclonal Antibodies", BIOPROCESS INTERNATIONAL, INFORMA LIFE SCIENCES GROUP, US, US , (20150901), vol. 13, no. 8, ISSN 1542-6319, pages 1 - 7, XP093276852 | - |
| OPPOSITION | - Anonymous Dahai, Kang Jichao, "Comparing SDS-PAGE and CE-SDS for Antibody Purity Analysis", BIOPROCESS INTERNATIONAL, INFORMA LIFE SCIENCES GROUP, US, US , (20140401), vol. 12, no. 4, ISSN 1542-6319, pages 28 - 30, XP093276850 | - |
| OPPOSITION | - Anonymous, "Development Of Low Pyrogenic Response And Ultra-Low Metal Ion Extractables Zeta Plus™ Filter Medium", Customer Application Brief, 3M Purification Inc., pages 1 - 4, Customer Application Brief, URL: https://www.bioprocessonline.com/doc/development-of-low-pyrogenic-response-and-0001, XP093277005 | - |
| OPPOSITION | - Anonymous, "Filtration Selection Guide - Choosing the Right Filter for Your Application", Millipore Filtration Selection Guide, Millipore Corp., pages 1 - 75, Millipore Filtration Selection Guide, URL: https://www.lenntech.com/Data-sheets/Millipore-Filtration-Selection-Guide-L.pdf, XP093191814 | - |
| OPPOSITION | - Anonymous, "Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission: Draft", Process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission - Scientific guideline, European Medicines Agency, pages 1 - 11, Process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission - Scientific guideline, URL: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-process-validation-manufacture-biotechnology-derived-active-substances-and-data-be-provided-regulatory-submission_en.pdf, XP093276861 | - |
| OPPOSITION | - Anonymous Herb, Abbott Ian, Blanchard Mark, Parampalli Ananth, Setiabudi George, Chiruvolu Vijay, Noguchi Megumi, "Considerations for Scaling-up Depth Filtration of Harvested Cell Culture Fluid", BIOPHARM INTERNATIONAL, ADVANSTAR COMMUNICATIONS, DULUTH, MN, US, US , (20090301), vol. 22, no. 3, ISSN 1542-166X, pages 58 - 66, XP093276355 | - |
| OPPOSITION | - Anonymous, "HERCEPTIN® (trastuzumab)", HIGHLIGHTS OF PRESCRIBING INFORMATION, (20101001), pages 1 - 33, XP055857081 | - |
| OPPOSITION | - Anonymous, "HIGHLIGHTS OF PRESCRIBING INFORMATION HUMIRA (adalimumab) Injection, Solution for Subcutaneous use ", HUMIRA (adalimumab) Injection, Solution for Subcutaneous use, FDA, pages 1 - 70, HUMIRA (adalimumab) Injection, Solution for Subcutaneous use , URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125057s0276lbl.pdf, XP093276195 | - |
| OPPOSITION | - Anonymous, "HIGHLIGHTS OF PRESCRIBING INFORMATION OCREVUS TM (ocrelizumab) injection, for intravenous use", OCREVUS TM (ocrelizumab) injection, for intravenous use, FDA, pages 1 - 18, OCREVUS TM (ocrelizumab) injection, for intravenous use, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761053lbl.pdf, XP093276187 | - |
| OPPOSITION | - Anonymous, "incubate - Medical Definition", Merriam-Webster dictionary, Merriam-Webster, pages 1 - 1, Merriam-Webster dictionary, URL: https://www.merriam-webster.com/dictionary/incubate#medicalDictionary, XP093276157 | - |
| OPPOSITION | - Anonymous, "Incubate", OXFORD DICTIONARY OF BIOCHEMISTRY AND MOLECULAR BIOLOGY, SECOND EDITION, Oxford University Press, (20060101), pages 340 - 340, ISBN 978-0-19-852917-0, XP093276160 | - |
| OPPOSITION | - Anonymous Jennifer C, Moreno G. Tony, Lou Yun, Parikh Rahul, Farnan Dell, "High-Throughput Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies", BIOPHARM INTERNATIONAL, ADVANSTAR COMMUNICATIONS, DULUTH, MN, US, US , (20101101), vol. 23, no. 11, ISSN 1542-166X, pages 44 - 52, XP093276871 | - |
| OPPOSITION | - Anonymous, "Millistak+® Depth Filter in µPod® format, A1HC media series, 23 cm2 surface area, Luer fitting connection | MA1HC23CL3", Millipore Product Description, MERCK KGAA, pages 1 - 3, Millipore Product Description, URL: https://www.merckmillipore.com/GB/en/product/Millistak-Depth-Filter-in-Pod-format-A1HC-media-series-23cm2-surface-area-Luer-fitting-connection,MM_NF-MA1HC23CL3, XP093276939 | - |
| OPPOSITION | - Anonymous, "Millistak+® HC Pod Depth Filter, A1HC media series, 1.1 m2 surface area, 27/pack shipped on a North American standard sized pallet | MA1HC10FS27NA", Millipore Product Description, Merck KGaA, pages 1 - 3, Millipore Product Description, URL: https://www.merckmillipore.com/GB/en/product/Millistak-HC-Pod-Depth-Filter-A1HC-media-series-1.1m2-surface-area-27-pack-shipped-on-a-North-American-standard-sized-pallet,MM_NF-MA1HC10FS27NA, XP093276937 | - |
| OPPOSITION | - Anonymous, "Millistak+® HC Pod Depth Filter, X0HC media series, 0.11 m2 surface area | MX0HC01FS1", Merck Millipore Product description, MERCK KGAA, pages 1 - 3, Merck Millipore Product description, URL: https://www.merckmillipore.com/GB/en/product/Millistak-HC-Pod-Depth-Filter-X0HC-media-series-0.11m2-surface-area,MM_NF-MX0HC01FS1?ReferrerURL=https://www.google.com/, XP093276955 | - |
| OPPOSITION | - Anonymous, "Millistak+® Pod disposable depth filter system", Data Sheet Millistak+® Pod disposable depth filter system, MilliporeSigma, pages 1 - 8, Data Sheet Millistak+® Pod disposable depth filter system, URL: https://www.weichilab.com/upload/files/202003110214505490.pdf, XP093276168 | - |
| OPPOSITION | - Anonymous, "PRODUCTION AND QUALITY CONTROL OF MONOCLONAL ANTIBODIES", European Medicines Agency, pages 237 - 262, European Medicines Agency, URL: https://www.ema.europa.eu/en/documents/scientific-guideline/production-and-quality-control-monoclonal-antibodies_en.pdf, (20240402), XP093147245 | - |
| OPPOSITION | - Anonymous, "Sartoclear P Maxicaps: Cell Clarification and containment Removal", Brochure Sartoclear P Maxicaps, Sartorius Stedim, pages 1 - 4, Brochure Sartoclear P Maxicaps, URL: http://satorius-stedim.com, XP093276453 | - |
| OPPOSITION | - Anonymous, "Seitz® P-series Depth Filter Sheets", Product leaflet, Product leaflet, (20171219), XP055436620 | - |
| OPPOSITION | - Anonymous, "Supracap ™ Depth Filter Capsules", Brochure Supracap ™ Depth Filter Capsules, Pall Life Sciences, pages 1 - 12, Brochure Supracap ™ Depth Filter Capsules, URL: http://www.pall.com/biopharm, XP093276431 | - |
| OPPOSITION | - Anonymous, "Using Millistak+ HC Filters for Mammalian Cell Culture Clarification", EMD Millipore Application Note, Millipore Corp., pages 1 - 30, EMD Millipore Application Note, URL: http://www.millipore.com, XP093277021 | - |
| OPPOSITION | - Anonymous, "Viresolve® Prefilter: Extractables Characterization", Application Note, Merck KGaA, Darmstadt, Germany, Darmstadt, Germany, pages 1 - 7, Application Note, URL: https://www.merckmillipore.com/INTERSHOP/web/WFS/Merck-JP-Site/ja_JP/-/JPY/ShowDocument-File?ProductSKU=MM_NF-C7474&DocumentId=201306.13160.ProNet&DocumentType=TI&Language=EN&Country=NF&Origin=PDP, XP093276993 | - |
| OPPOSITION | - Anonymous, "Zeta Plus® BioCap™ Disposable Filter Capsules", Product Data Sheet, (19970101), pages FP, 1 - 7, XP093195612 | - |
| OPPOSITION | - Anonymous, "Zeta Plus™ C (P) & S (P) Series - Lenticular Depth Filter Cartridges ", Product Information Zeta Plus™ C (P) & S (P) Series, 3M United Kingdom plc, pages 1 - 4, Product Information Zeta Plus™ C (P) & S (P) Series, URL: https://www.fuhr-gmbh.com/pdf_dateien/3m/e_zetaplus_cs.pdf, XP093276170 | - |
| OPPOSITION | - Anonymous, "Zeta Plus ™ DELI and DELP Series Filter Media", Brochure: Zeta Plus™ DELI and DELP, 3M Purification Inc., pages 1 - 4, Brochure: Zeta Plus™ DELI and DELP , URL: https://multimedia.3m.com/mws/media/493982O/zeta-plus-tm-del-series-depth-filter.pdf, XP093276185 | - |
| OPPOSITION | - Anonymous, "Zeta Plus ™ EXT SP Series Lenticular Depth Filter Cartridges", Leaflet: Zeta Plus ™ EXT SP Series, 3M/ Lenntech, pages 1 - 5, Leaflet: Zeta Plus ™ EXT SP Series, URL: https://www.lenntech.com/Data-sheets/ZetaPlus-EXT-SP-Series-C.pdf, XP093277168 | - |
| OPPOSITION | - Blanc Tim, "Details of a Monoclonal Antibody's Reduction and Re-oxidation from Cell Culture through Purification", CE in Biotechnology & Pharmaceutical Industries: 12th Symposium on the Practical Applications for the Analysis of Proteins, Nucleotides and Small Molecules (CE Pharm 2010); October 17-21, 2010 Vancouver Marriott Pinnacle Vancouver, BC Canada, CASSS, (20101019), page 1,9,26, XP093276845 | - |
| OPPOSITION | - Blanc Tim, Gordon Freckleton, Tun Liu, Richard Seipert, Mark Richards, Joseph Troiano, Daniel Valez, Girish Pendse, Michael Barry, Richard Crowley, Qinwei Zhou, "Details of a monoclonal antibody's reduction and re-oxidation from cell culture through purification", Presentation at CE in Biotechnology & Pharmaceutical Industries: 12th Symposium on the Practical Applications for the Analysis of Proteins, Nucleotides and Small Molecules (CE Pharm 2010); October 17-21, 2010 Vancouver Marriott Pinnacle Vancouver, BC Canada, CASSS, (20101019), pages 1 - 40, XP093276840 | - |
| OPPOSITION | - Capozzi G., Modena G., "Chapter 17 - Oxidation of thiols", The Chemistry of the Thiol Group, (19740101), pages 785 - 839, XP093195623 | - |
| OPPOSITION | - D160 - Email exchange with American Chemical Society (ACS) - 16 April 2025 | - |
| OPPOSITION | - D162 - Evidence relating to 2016_BIOT_Abstracts availability | - |
| OPPOSITION | - D56 - Overview of support for amended claims in the application as filed | - |
| OPPOSITION | - Emdmillipore, "Millistak+® Pod Disposable Depth Filter ", Performance Guide, (20130601), pages 1 - 28, XP093195614 | - |
| OPPOSITION | - Emea, "Guideline On Development, Production, Characterisation and Specifications for Monoclonal Antibodies and Related Products", EMEA/CHMP/BWP/157653/2007, (20081218), pages 1 - 11, XP093195606 | - |
| OPPOSITION | - Faber Rene, Yang Yujing, Gottschalk Uwe, "Salt Tolerant Interaction Chromatography for Large-Scale Polishing with Convective Media", BIOPHARM INTERNATIONAL, ADVANSTAR COMMUNICATIONS, DULUTH, MN, US, US , (20091002), vol. 2009, no. Suppl. 7, ISSN 1542-166X, XP093195615 | - |
| OPPOSITION | - Gennaro Lynn, Felten Chantal, Oscar Salas-Salano, "Optimization Approaches in the Routine Analysis of Monoclonal Anitbodies by Capillary Electrophoresis", LCGC Europe, Advanstar Communications (UK) Ltd., United Kingdom, United Kingdom , (20081201), vol. 21, no. 12, ISSN 1471-6577, pages 615 - 622, XP093195079 | - |
| OPPOSITION | - Hoang Hai, "BIOT 213 Re-oxidization of partially reduced monoclonal antibody by charged depth filters ", Abstracts of Papers ; ACS National Meeting & Exposition, American Chemical Society, US, US , (20160313), vol. 251, ISSN 0065-7727, pages 1 - 1, XP093276202 | - |
| OPPOSITION | - Hoang Hai, "BIOT 213 Re-oxidization of partially reduced monoclonal antibody by charged depth filters", Abstracts of Papers ; ACS National Meeting & Exposition, American Chemical Society, US, US , (20160313), vol. 251, ISSN 0065-7727, pages 148 - 148, XP093277164 | - |
| OPPOSITION | - Jornitz Maik W., Meltzer Theodore H., "Filtration and Purification in the Biopharmaceutical Industry (passage)", Filtration and Purification in the Biopharmaceutical Industry, 2nd ed., Informa Healthcare, (20080101), page 540, ISBN 0-8493-7953-9, XP093195625 | - |
| OPPOSITION | - Kadey, Jr. Frederic L., "Diatomite", Industrial Minerals and Rocks, Society of Mining Engineers of the American Institute of Mining, Metallurgical, and Petroleum Engineers, (19830101), pages 677 - 708, ISBN 0-89520-417-7, XP093195613 | - |
| OPPOSITION | - Millipore, "Millistak+® Pods", Validation Guide, (20150201), pages FP, 1 - 105, XP093195636 | - |
| OPPOSITION | - Millipore Sigma, "Pod Depth Filters", User Guide, (20210501), pages 1 - 12, XP093195630 | - |
| OPPOSITION | - "Millistak+® Pod Disposable Depth Filter System", Data Sheet Millipore, Millipore Corporation, pages 1 - 4, Data Sheet Millipore, URL: http://fscimage.fishersci.com/cmsassets/downloads/segment/Scientific/pdf/Millipore/millistak_pod.pdf, (20131114), XP055088250 | - |
| OPPOSITION | - O'brien Thomas P, Brown Laura A, Battersby Dennis G, Rudolph Aimee S, Raman L P, "Large-Scale, Single-Use Depth Filtration Systems for Mammalian Cell Culture Clarification", BioProcess International, (20120501), vol. 10, no. 5s, pages 50 - 57, XP093195594 | - |
| OPPOSITION | - Schreffler John, Bailley Matthew, Klimek Tom, Agneta Peter, Wiltsie W Erick, Felo Michael, Maisey Pam, Zuo Xun, Routhier Eric, "Characterization of Postcapture Impurity Removal Across an Adsorptive Depth Filter", BioProcess TECHNICAL, (20150301), vol. 13, no. 3, pages 36 - 45, XP093195617 | - |
| OPPOSITION | - Shukla, A.A. ; Thommes, J., "Recent advances in large-scale production of monoclonal antibodies and related proteins", TRENDS IN BIOTECHNOLOGY., ELSEVIER PUBLICATIONS, CAMBRIDGE., GB, GB , (20100501), vol. 28, no. 5, ISSN 0167-7799, pages 253 - 261, XP027020088 | - |
| OPPOSITION | - Shukla Abhinav A, Mostafa Sigma, Wilson Mark, Lange Dirk, "Vertical Integration of Disposables in Biopharmaceutical Drug Substance Manufacturing", BIOPROCESS INTERNATIONAL, INFORMA LIFE SCIENCES GROUP, US, US , (20120601), vol. 10, no. 6, ISSN 1542-6319, pages 34 - 47, XP093276231 | - |
| OPPOSITION | - Sonderegger Corinna, "Antibody reduction and more recent challenges to the scale-up of cho manufacturing processes", Wilbio 14th Waterside Conference in San Francisco, April 20-22, 2009, Sandoz AG, (20090420), pages 1 - 14, XP093276833 | - |
| OPPOSITION | - Sonderegger Corinna, "Quality-by-Design based Process Development for Biopharmaceuticalsconcepts and case studies", BioPharmAsia Singapore, Sep. 9-10th 2008, Sandoz, (20080909), pages 1 - 34, XP093276524 | - |
| OPPOSITION | - Thillaivinayagalingam Piranavan, Anthony R Newcombe, "Validation of Intermediate Hold Times", BIOPROCESS INTERNATIONAL, INFORMA LIFE SCIENCES GROUP, US, US , (20110401), vol. 9, no. 4, ISSN 1542-6319, pages 52 - 57, XP093276464 | - |
| OPPOSITION | - Wehr Tim, Wehr Tim, "Capillary electrophoresis in the biopharmaceutical industry: Part I", LC GC NORTH AMERICA, ADVANSTAR COMMUNICATIONS, DULUTH, MN, US, US , (20050701), vol. 23, no. 7, ISSN 1527-5949, pages 676 - 681, XP093195074 | - |
| OPPOSITION | - Wenz Christian, "Performance of commercially available gels for protein characterization by capillary gel electrophoresis with UV detection on the Agilent 7100 CE System", Agilent Technologies - Application Note, Agilent Technologies - Application Note, URL: https://www.agilent.com/cs/library/applications/5990-7976EN.pdf, XP093195077 | - |
| OPPOSITION | - Yavorsky Dav, Robert Blanck, Charles Lambalot, Roger Brunkow, "The clarification of bioreactor cell cultures for biopharmaceuticals", Pharmaceutical Technolog, (20030301), pages 62 - 76, XP093195067 | - |
| OPPOSITION | - Engh Kenneth R., "Diatomite", KIRK-OTHMER ENCYCLOPEDIA OF CHEMICAL TECHNOLOGY (4th edition), Hoboken, NJ, USA , Wiley-Interscience , (20140101), pages 1 - 11, doi:10.1002/0471238961.0409012005140708.a01.pub2, ISBN 978-0-471-48494-3, XP093195600 | |
| OPPOSITION | - Alice Wang; Rachael Lewus; Anurag S. Rathore, "Comparison of different options for harvest of a therapeutic protein product from high cell density yeast fermentation broth", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20060126), vol. 94, no. 1, doi:10.1002/bit.20816, ISSN 0006-3592, pages 91 - 104, XP071052269 | |
| OPPOSITION | - Melody Trexler‐Schmidt; Sandy Sargis; Jason Chiu; Stefanie Sze‐Khoo; Melissa Mun; Yung‐Hsiang Kao; Michael W. Laird, "Identification and prevention of antibody disulfide bond reduction during cell culture manufacturing", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20100222), vol. 106, no. 3, doi:10.1002/bit.22699, ISSN 0006-3592, pages 452 - 461, XP071155447 | |
| OPPOSITION | - Yung‐Hsiang Kao; Daniel P. Hewitt; Melody Trexler‐Schmidt; Michael W. Laird, "Mechanism of antibody reduction in cell culture production processes", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20100629), vol. 107, no. 4, doi:10.1002/bit.22848, ISSN 0006-3592, pages 622 - 632, XP071152739 | |
| OPPOSITION | - Sharon X. Gao; Ying Zhang; Kensey Stansberry‐Perkins; Alex Buko; Shujun Bai; Vanessa Nguyen; Mark L. Brader, "Fragmentation of a highly purified monoclonal antibody attributed to residual CHO cell protease activity", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20101117), vol. 108, no. 4, doi:10.1002/bit.22982, ISSN 0006-3592, pages 977 - 982, XP071104140 | |
| OPPOSITION | - María Vázquez‐Rey; Dietmar A. Lang, "Aggregates in monoclonal antibody manufacturing processes", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20110420), vol. 108, no. 7, doi:10.1002/bit.23155, ISSN 0006-3592, pages 1494 - 1508, XP071113761 | |
| OPPOSITION | - Timothy Iskra; Glen R. Bolton; Jonathan L. Coffman; Ranga Godavarti, "The effect of protein a cycle number on the performance and lifetime of an anion exchange polishing step", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20121210), vol. 110, no. 4, doi:10.1002/bit.24781, ISSN 0006-3592, pages 1142 - 1152, XP071113994 | |
| OPPOSITION | - Melissa Mun; Stefanie Khoo; Aline Do Minh; James Dvornicky; Melody Trexler‐Schmidt; Yung‐Hsiang Kao; Michael W. Laird, "Air sparging for prevention of antibody disulfide bond reduction in harvested CHO cell culture fluid", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20141223), vol. 112, no. 4, doi:10.1002/bit.25495, ISSN 0006-3592, pages 734 - 742, XP071096717 | |
| OPPOSITION | - Nripen Singh; Abhiram Arunkumar; Srinivas Chollangi; Zhijun George Tan; Michael Borys; Zheng Jian Li, "Clarification technologies for monoclonal antibody manufacturing processes: Current state and future perspectives", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20150929), vol. 113, no. 4, doi:10.1002/bit.25810, ISSN 0006-3592, pages 698 - 716, XP071098101 | |
| OPPOSITION | - Wai Keen Chung; Brian Russell; Yanhong Yang; Michael Handlogten; Suzanne Hudak; Mingyan Cao; Jihong Wang; David Robbins; Sanjeev Ahuja; Min Zhu, "Effects of antibody disulfide bond reduction on purification process performance and final drug substance stability", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20170306), vol. 114, no. 6, doi:10.1002/bit.26265, ISSN 0006-3592, pages 1264 - 1274, XP071153334 | |
| OPPOSITION | - Brian O’MaraZhong‐Hua GaoManju KurugantiRobert MallettGautam NayarLaura SmithJeffrey D. MeyerJon TherriaultCameron MillerJohn CisneyJohn Fann, "Impact of depth filtration on disulfide bond reduction during downstream processing of monoclonal antibodies from CHO cell cultures", Biotechnology and Bioengineering, John Wiley, Hoboken, USA, Hoboken, USA, (20190404), vol. 116, no. 7, doi:10.1002/bit.26964, ISSN 0006-3592, pages 1669 - 1683, XP071108839 | |
| OPPOSITION | - P. A. Marichal‐Gallardo; M. M. Álvarez, "State‐of‐the‐art in downstream processing of monoclonal antibodies: Process trends in design and validation", Biotechnology Progress, American Chemical Society, Hoboken, USA, Hoboken, USA, (20120626), vol. 28, no. 4, doi:10.1002/btpr.1567, ISSN 8756-7938, pages 899 - 916, XP072294049 | |
| OPPOSITION | - Adith Venkiteshwaran; Jace Fogle; Purbasa Patnaik; Ron Kowle; Dayue Chen, "Mechanistic evaluation of virus clearance by depth filtration", Biotechnology Progress, American Chemical Society, Hoboken, USA, Hoboken, USA, (20150304), vol. 31, no. 2, doi:10.1002/btpr.2061, ISSN 8756-7938, pages 431 - 437, XP072293407 | |
| OPPOSITION | - Richard R. Rustandi; Michael W. Washabaugh; Yang Wang, "Applications of CE SDS gel in development of biopharmaceutical antibody‐based products", Electrophoresis, Verlag Chemie, Hoboken, USA, Hoboken, USA, (20080919), vol. 29, no. 17, doi:10.1002/elps.200700958, ISSN 0173-0835, pages 3612 - 3620, XP071498944 | |
| OPPOSITION | - Amy Guo; Mei Han; Theresa Martinez; Randal R. Ketchem; Shawn Novick; Claudia Jochheim; Alain Balland, "Electrophoretic evidence for the presence of structural isoforms specific for the IgG2 isotype", Electrophoresis, Verlag Chemie, Hoboken, USA, Hoboken, USA, (20080521), vol. 29, no. 12, doi:10.1002/elps.200800083, ISSN 0173-0835, pages 2550 - 2556, XP071499511 | |
| OPPOSITION | - David A. Michels; Monica Parker; Oscar Salas‐Solano, "Quantitative impurity analysis of monoclonal antibody size heterogeneity by CE‐LIF: Example of development and validation through a quality‐by‐design framework", Electrophoresis, Verlag Chemie, Hoboken, USA, Hoboken, USA, (20120319), vol. 33, no. 5, doi:10.1002/elps.201100528, ISSN 0173-0835, pages 815 - 826, XP071501700 | |
| OPPOSITION | - Burgstaller Daniel, Krepper Walpurga, Haas Josselyn, Maszelin Marine, Mohoric Jure, Pajnic Katja, Jungbauer Alois, Satzer Peter, "Continuous cell flocculation for recombinant antibody harvesting", Journal of Chemical Technology and Biotechnology, wiley, Hoboken, USA, Hoboken, USA, (20180701), vol. 93, no. 7, doi:10.1002/jctb.5500, ISSN 0268-2575, pages 1881 - 1890, XP093276345 | |
| OPPOSITION | - Gramer Michael J., "Product Quality Considerations for Mammalian Cell Culture Process Development and Manufacturing", Mammalian Cell Cultures for Biologics Manufacturing, Berlin, Heidelberg, Springer Berlin Heidelberg, (20130101), pages 123 - 166, doi:10.1007/10_2013_214, ISSN 0724-6145, ISBN 978-3-642-54050-9, XP093039744 | |
| OPPOSITION | - Ma S., Nashabeh W., "Analysis of Protein Therapeutics by Capillary Electrophoresis", CE in Biotechnology: Practical Applications for Protein and Peptide Analyses, Wiesbaden, Vieweg+Teubner Verlag, (20010101), pages 75 - 89, doi:10.1007/978-3-322-83021-0_9, ISSN 1615-2255, ISBN 978-3-322-83021-0, XP055908674 | |
| OPPOSITION | - S. Mendioroz, M. J. Belzunce, J. A. Pajares, "Thermogravimetric study of diatomites", JOURNAL OF THERMAL ANALYSIS., HEYDEN AND SON, LONDON., GB, GB , (19891101), vol. 35, no. 7, doi:10.1007/BF01911874, ISSN 0368-4466, pages 2097 - 2104, XP055410300 | |
| OPPOSITION | - Zydney, Van Reis, Butler Michael; Webb, Moo-Young Murray, Webb Colin, "Bioseparations: Membrane Processes ", Comprehensive Biotechnology, Academic Press, (20110720), pages 499 - 520, doi:10.1016/B978-0-08-088504-9.00440-2, ISBN 978-0-444-53352-4, XP009561098 | |
| OPPOSITION | - Conner John, Wuchterl Don, Lopez Maria, Minshall Bill, Prusti Rabi, Boclair Dave, Peterson Jay, Allen Chris, "Chapter 26 - The Biomanufacturing of Biotechnology Products", Biotechnology Entrepreneurship: Starting, Managing, and Leading Biotech Companies, Elsevier Inc, (20140626), pages 351 - 385, doi:10.1016/B978-0-12-404730-3.00026-9, ISBN 9780124047471, XP009561130 | |
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| OPPOSITION | - Suminda Hapuarachchi; Szilan Fodor; Izydor Apostol; Gang Huang;, "Use of capillary electrophoresissodium dodecyl sulfate to monitor disulfide scrambled forms of an Fc fusion protein during purification process", Analytical Biochemistry, Academic Press, Amsterdam, NL, Amsterdam, NL , (20110314), vol. 414, no. 2, doi:10.1016/j.ab.2011.03.017, ISSN 0003-2697, pages 187 - 195, XP028210307 | |
| OPPOSITION | - Birch, J.R. ; Racher, A.J., "Antibody production", Advanced Drug Delivery Reviews, Elsevier, Amsterdam , NL, Amsterdam , NL , (20060807), vol. 58, no. 5-6, doi:10.1016/j.addr.2005.12.006, ISSN 0169-409X, pages 671 - 685, XP024892148 | |
| OPPOSITION | - Kristen L. Koterba; Trissa Borgschulte; Michael W. Laird;, "Thioredoxin 1 is responsible for antibody disulfide reduction in CHO cell culture", Journal of Biotechnology, Elsevier, Amsterdam NL, Amsterdam NL , (20111116), vol. 157, no. 1, doi:10.1016/j.jbiotec.2011.11.009, ISSN 0168-1656, pages 261 - 267, XP028395757 | |
| OPPOSITION | - Shukla, A.A. Hubbard, B. Tressel, T. Guhan, S. Low, D., "Downstream processing of monoclonal antibodies-Application of platform approaches", Journal of Chromatography B, ELSEVIER, AMSTERDAM., NL, NL , (20070312), vol. 848, no. 1, doi:10.1016/j.jchromb.2006.09.026, ISSN 1570-0232, pages 28 - 39, XP005922825 | |
| OPPOSITION | - Flatman, S. Alam, I. Gerard, J. Mussa, N., "Process analytics for purification of monoclonal antibodies", Journal of Chromatography B, ELSEVIER, AMSTERDAM., NL, NL , (20070312), vol. 848, no. 1, doi:10.1016/j.jchromb.2006.11.018, ISSN 1570-0232, pages 79 - 87, XP005922829 | |
| OPPOSITION | - Wang Tian, Liu Yaoqing Diana, Cai Bing, Huang Gang, Flynn Gregory C., "Investigation of antibody disulfide reduction and re-oxidation and impact to biological activities", Journal of Pharmaceutical and Biomedical Analysis, Elsevier B.V., AMSTERDAM, NL, AMSTERDAM, NL , (20150105), vol. 102, doi:10.1016/j.jpba.2014.10.023, ISSN 0731-7085, pages 519 - 528, XP093276235 | |
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| OPPOSITION | - Tomic Sladjana; Besnard Lise; Fürst Benjamin; Reithmeier Rainer; Wichmann Rolf; Schelling Pierre; Hakemeyer Christian , "Complete clarification solution for processing high density cell culture harvests", SEPARATION AND PURIFICATION TECHNOLOGY, ELSEVIER SCIENCE, AMSTERDAM, NL, NL , (19000101), vol. 141, doi:10.1016/j.seppur.2014.12.002, ISSN 1383-5866, pages 269 - 275, XP029132484 | |
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| OPPOSITION | - Oscar Salas-Solano, Chantal Felten, "15 Capillary electrophoresis and bioanalysis", Capillary electrophoresis methods for pharmaceutical analysis, Elsevier , (20080911), pages 401 - 424, doi:10.1016/S0149-6395(07)00015-3, ISBN 978-0-12-372573-8, XP055551375 | |
| OPPOSITION | - MAGNUSSON C G , BJOERNSTEDT M, HOLMGREN A, "Human IgG is substrate for the thioredoxin system: differential cleavage pattern of interchain disulfide bridges in IgG subclasses.", Molecular Immunology, PERGAMON, GB, GB , (19970701), vol. 34, no. 10, doi:10.1016/S0161-5890(97)00092-8, ISSN 0161-5890, pages 709 - 717, XP002497450 | |
| OPPOSITION | - Oscar Salas-Solano, Brandon Tomlinson, Sarah Du, Monica Parker, Alex Strahan, Stacey Ma, "Optimization and Validation of a Quantitative Capillary Electrophoresis Sodium Dodecyl Sulfate Method for Quality Control and Stability Monitoring of Monoclonal Antibodies", Analytical Chemistry, American Chemical Society, (20060901), vol. 78, no. 18, doi:10.1021/ac060828p, pages 6583 - 6594, XP055551312 | |
| OPPOSITION | - David A. Michels, Lowell J. Brady, Amy Guo, Alain Balland, "Fluorescent Derivatization Method of Proteins for Characterization by Capillary Electrophoresis- Sodium Dodecyl Sulfate with Laser-Induced Fluorescence Detection", Analytical Chemistry, American Chemical Society, (20070801), vol. 79, no. 15, doi:10.1021/ac0705521, pages 5963 - 5971, XP055551326 | |
| OPPOSITION | - Michels David A., Lowell J. Brady, Amy Guo, Alain Balland, "Supporting Information: Fluorescent derivatization method of proteins for characterization by capillary electrophoresis-sodium dodecyl sulfate with laser-induced fluorescence detection", Analytical Chemistry, American Chemical Society, (20070801), vol. 79, no. 15, doi:10.1021/ac0705521, ISSN 0003-2700, pages 1 - 6, XP093276897 | |
| OPPOSITION | - Hunt, Et Al, "Capillary electrophoresis sodium dodecyl sulfate nongel sieving analysis of a therapeutic recombinant monoclonal antibody: a biotechnology perspective", Anal Chem., (19990101), vol. 71, no. 13, doi:10.1021/ac981209m, pages 2390 - 2397, XP055534370 | |
| OPPOSITION | - Theresa Martinez, Amy Guo, Martin J. Allen, Mei Han, Danielle Pace, Jay Jones, Ron Gillespie, Randal R. Ketchem, Yuling Zhang, Alain Balland, "Disulfide connectivity of human immunoglobulin G2 structural isoforms.", Journal of Biological Chemistry, American Society for Biochemistry and Molecular Biology, US, US , (20080715), vol. 47, no. 28, doi:10.1021/BI800576C, ISSN 0021-9258, pages 7496 - 7508, XP002512403 | |
| OPPOSITION | - Wei Zhang; Marta J. Czupryn, "Free Sulfhydryl in Recombinant Monoclonal Antibodies", Biotechnology Progress, American Chemical Society, Hoboken, USA, Hoboken, USA, (20080905), vol. 18, no. 3, doi:10.1021/bp025511z, ISSN 8756-7938, pages 509 - 513, XP072297313 | |
| OPPOSITION | - Wendy B. Chaderjian; Edward T. Chin; Reed J. Harris; Tina M. Etcheverry, "Effect of Copper Sulfate on Performance of a Serum‐Free CHO Cell Culture Process and the Level of Free Thiol in the Recombinant Antibody Expressed", Biotechnology Progress, American Chemical Society, Hoboken, USA, Hoboken, USA, (20080905), vol. 21, no. 2, doi:10.1021/bp0497029, ISSN 8756-7938, pages 550 - 553, XP072297065 | |
| OPPOSITION | - Yinges Yigzaw; Robert Piper; Minh Tran; Abhinav A. Shukla, "Exploitation of the Adsorptive Properties of Depth Filters for Host Cell Protein Removal during Monoclonal Antibody Purification", Biotechnology Progress, American Chemical Society, Hoboken, USA, Hoboken, USA, (20080916), vol. 22, no. 1, doi:10.1021/bp050274w, ISSN 8756-7938, pages 288 - 296, XP072299095 | |
| OPPOSITION | - Brian Kelley, "Very Large Scale Monoclonal Antibody Purification: The Case for Conventional Unit Operations", Biotechnology Progress, American Chemical Society, Hoboken, USA, Hoboken, USA, (20080905), vol. 23, no. 5, doi:10.1021/bp070117s, ISSN 8756-7938, pages 995 - 1008, XP072297051 | |
| OPPOSITION | - David J. Roush; Yuefeng Lu, "Advances in Primary Recovery: Centrifugation and Membrane Technology", Biotechnology Progress, American Chemical Society, Hoboken, USA, Hoboken, USA, (20080905), vol. 24, no. 3, doi:10.1021/bp070414x, ISSN 8756-7938, pages 488 - 495, XP072295410 | |
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| OPPOSITION | - HOLLIGER PHILIPP; HUDSON PETER J, "ENGINEERED ANTIBODY FRAGMENTS AND THE RISE OF SINGLE DOMAINS", Nature Biotechnology, Nature Publishing Group US, New York, New York, (20050901), vol. 23, no. 9, doi:10.1038/nbt1142, ISSN 1087-0156, pages 1126 - 1136, XP008076746 | |
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| OPPOSITION | - FAHRNER R L, ET AL., "Industrial Purification of Pharmaceutical Antibodies: Development, Operation, and Validation of Chromatography Processes", BIOTECHNOLOGY AND GENETIC ENGINEERING REVIEWS, INTERCEPT LTD., ANDOVER, GB, GB , (20010701), vol. 18, doi:10.1080/02648725.2001.10648017, ISSN 0264-8725, pages 301 - 327, XP008034714 | |
| OPPOSITION | - Wang Wei-Han, Cheung-Lau Jasmina, Chen Yan, Lewis Michael, Tang Qing Mike, "Specific and high-resolution identification of monoclonal antibody fragments detected by capillary electrophoresis-sodium dodecyl sulfate using reversed-phase HPLC with top-down mass spectrometry analysis", mAbs, Landes Bioscience, US, US , (20191003), vol. 11, no. 7, doi:10.1080/19420862.2019.1646554, ISSN 1942-0862, pages 1233 - 1244, XP093276246 | |
| OPPOSITION | - Wang Wei-Han, Cheung-Lau Jasmina, Chen Yan, Lewis Michael, Tang Qing Mike, "Supplemental Material: Specific and high-resolution identification of monoclonal antibody fragments detected by capillary electrophoresis-sodium dodecyl sulfate using reversed-phase HPLC with top-down mass spectrometry analysis", mAbs, Landes Bioscience, US, US , (20191003), vol. 11, no. 7, doi:10.1080/19420862.2019.1646554, ISSN 1942-0862, pages 1 - 15, XP093277180 | |
| OPPOSITION | - P. S. Rommer; A. Dudesek; O. Stüve; U.K. Zettl, "Monoclonal antibodies in treatment of multiple sclerosis", Clinical and experimental immunology, Wiley-Blackwell Publishing Ltd., GB, GB , (20140204), vol. 175, no. 3, doi:10.1111/cei.12197, ISSN 0009-9104, pages 373 - 384, XP071084519 | |
| OPPOSITION | - Zhang Jinyou, "Manufacture of Mammalian Cell Biopharmaceuticals", Manual of Industrial Microbiology and Biotechnology, ASM Press, (20100325), pages 179 - 195, doi:10.1128/9781555816827.ch13, ISBN 978-1-55581-512-7, XP093276886 | |
| OPPOSITION | - Brian Mullan;Bryan Dravis;Amareth Lim;Ambrose Clarke;Susan Janes;Pete Lambooy;Don Olson;Tomas O’Riordan;Bruce Ricart;Alexander G Tul, "Disulphide bond reduction of a therapeutic monoclonal antibody during cell culture manufacturing operations", BMC Proceedings, BioMed Central Ltd, London UK, London UK , (20111122), vol. 5, no. Suppl 8, doi:10.1186/1753-6561-5-S8-P110, ISSN 1753-6561, page P110, XP021114361 | |
| OPPOSITION | - Julie Ruaudel, Martin Bertschinger, Sonia Letestu, Roberto Giovannini, Paul Wassmann, Pierre Moretti, "Antibody disulfide bond reduction during process development: Insights using a scale-down model process", BMC Proceedings, BioMed Central Ltd, (20151214), vol. 9, no. S9, doi:10.1186/1753-6561-9-S9-P24, XP055591553 | |
| OPPOSITION | - C. Nattrass;C. J. Horwell;D. E. Damby;A. Kermanizadeh;D. M. Brown;V. Stone, "The global variability of diatomaceous earth toxicity: a physicochemical and in vitro investigation", Journal of Occupational Medicine and Toxicology, BioMed Central Ltd, Lo, Lo , (20150710), vol. 10, no. 1, doi:10.1186/s12995-015-0064-7, ISSN 1745-6673, page 23, XP021228690 | |
| OPPOSITION | - Feng Li, Brian Lee, Joe X. Zhou, Tim Tressel, Xiaoming Yang, "Current therapeutic antibody production and process optimization", BIOPROCESSING JOURNAL: ADVANCES AND TRENDS IN BIOLOGICAL PRODUCT DEVELOPMENT, WILLIAMSBURG BIOPROCESSING FOUNDATION, US, US , (20050901), vol. 5, no. 4, doi:10.12665/J54.LiZhou, ISSN 1538-8786, pages 23 - 30, XP002519952 | |
| OPPOSITION | - Jenkins Nigel, Castro Maria, Windeatt Simon, Perone Marcelo, "21. Control of Proteolysis in Cell Culture", Animal cell biotechnology : methods and protocols, Totowa, NJ, Humana Press, (19990101), vol. 8, pages 263 - 276, doi:10.1385/0-89603-547-6:263, ISSN 1940-6061, ISBN 0-89603-547-6, XP009561099 | |
| OPPOSITION | - Reka Arianit A., Pavlovski Blagoj, Fazlija Emira, Berisha Avni, Pacarizi Musaj, Daghmehchi Maria, Sacalis Carmen, Jovanovski Gligor, Makreski Petre, Oral Ayhan, "Diatomaceous Earth: Characterization, thermal modification, and application", OPEN CHEM., (20210101), vol. 19, no. 1, doi:10.1515/chem-2020-0049, ISSN 2391-5420, pages 451 - 461, XP093195604 | |
| OPPOSITION | - Katariina M Hutterer, Robert W Hong, Jonathon Lull, Xiaoyang Zhao, Tian Wang, Rex Pei, M Eleanor Le, Oleg Borisov, Rob Piper, Yaoqing Diana Liu, Krista Petty, Izydor Apostol, Gregory C Flynn, "Monoclonal antibody disulfide reduction during manufacturing: Untangling process effects from product effects.", mAbs, Landes Bioscience, US, US , (20130101), vol. 5, no. 4, doi:10.4161/mabs.2475, ISSN 1942-0862, pages 608 - 613, XP055514733 | |
| OPPOSITION | - Hui F. Liu, Ma Junfen, Winter Charles, Bayer Robert, "Recovery and purification process development for monoclonal antibody production", mAbs, (20100901), vol. 2, no. 5, doi:10.4161/mabs.2.5.12645, ISSN 19420862, pages 480 - 499, XP055027612 | |
| OPPOSITION | - Leslie A. Khawli, Sirj Goswami, Ryan Hutchinson, Zephania W. Kwong, Jihong Yang, Xiangdan Wang, Zhenling Yao, Alavattam Sreedhara, Tony Cano, Devin Tesar, Ihsan Nijem, David E. Allison, Pin Yee Wong, Yung-Hsiang Kao, Cynthia Quan, Amita Joshi, Reed J. Harris, Paul Motchnik, "Charge variants in IgG1: Isolation, characterization, in vitro binding properties and pharmacokinetics in rats", mAbs, (20101101), vol. 2, no. 6, doi:10.4161/mabs.2.6.13333, ISSN 19420862, pages 613 - 624, XP055090287 | |
| OPPOSITION | - Hongcheng Liu, Kimberly May, "Disulfide bond structures of IgG molecules : Structural variations, chemical modifications and possible impacts to stability and biological function", mAbs, Landes Bioscience, US, US , (20120101), vol. 4, no. 1, doi:10.4161/mabs.4.1.18347, ISSN 1942-0862, pages 17 - 23, XP055696189 | |
| OPPOSITION | - Catalin Doneanu, Alex Xenopoulos, Keith Fadgen, Jim Murphy, St. John Skilton, Holly Prentice, Martha Stapels, Weibin Chen, "Analysis of host-cell proteins in biotherapeutic proteins by comprehensive online two-dimensional liquid chromatography/mass spectrometry", mAbs, Landes Bioscience, US, US , (20120101), vol. 4, no. 1, doi:10.4161/mabs.4.1.18748, ISSN 1942-0862, pages 24 - 44, XP055297897 | |
