Impact of Product-Related Factors on Immunogenicity of Biotherapeutics

Cited by (350)

Items 101–200 of 350

1. Targeting ligand–receptor interactions for development of cancer therapeutics
   Jun W. Kim, Jennifer R. Cochran · 2017 · Current Opinion in Chemical Biology
2. Characterization of Adeno-Associated Virus Capsid Proteins with Two Types of VP3-Related Components by Capillary Gel Electrophoresis and Mass Spectrometry
   Hiroaki Oyama, Kentaro Ishii, Takahiro Maruno, Tetsuo Torisu, Susumu Uchiyama · 2021 · Human Gene Therapy
3. Critical considerations in the formulation development of parenteral biologic drugs
   Bilikallahalli K. Muralidhara, Marcus Wong · 2020 · Drug Discovery Today
4. Impact of deglycosylation and thermal stress on conformational stability of a full length murine igG2a monoclonal antibody: Observations from molecular dynamics simulations
   Xiaoling Wang, Sandeep Kumar, Patrick M. Buck, Satish Kumar Singh · 2012 · Proteins Structure Function and Bioinformatics
5. Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries
   E. Choy, R. Caporali, R. Xavier, B. Fautrel, R. Sanmartí, M. Bao, C. Bernasconi, A. Pethö-Schramm · 2017 · Rheumatology
6. Nonclinical Immunogenicity Risk Assessment of Therapeutic Proteins
   Sophie Tourdot, Timothy Paul Hickling · 2019 · Bioanalysis
7. Probing ensemble polymorphism and single aggregate structural heterogeneity in insulin amyloid self-assembly
   Giuseppe De Luca, Dirk Fennema Galparsoro, Giuseppe Sancataldo, Maurizio Leone, Vito Foderà, Valeria Vetri · 2020 · Journal of Colloid and Interface Science
8. Bulk production of the antiviral lectin griffithsin
   Joshua L. Fuqua, Krystal Teasley Hamorsky, Guruatma Khalsa, Nobuyuki Matoba, Kenneth E. Palmer · 2015 · Plant Biotechnology Journal
9. Therapeutic Effectiveness of Interferon Alpha 2b Treatment for COVID-19 Patient Recovery
   Ricardo Pereda, Daniel C. Gonzalez, Hubert Blas Rivero, Juan Carlos Rivero, Albadio Pérez, Lissette Del Rosario López, Natacha Mezquia, Rafael Venegas, Julio Roberto Betancourt, Rodolfo Emilio Domínguez et al. · 2020 · Journal of Interferon & Cytokine Research
10. Evolving strategies and application of proteins and peptide therapeutics in cancer treatment
    Anirban Goutam Mukherjee, Uddesh Ramesh Wanjari, Abilash Valsala Gopalakrishnan, Pragya Bradu, Antara Biswas, Raja Ganesan, Kaviyarasi Renu, Abhijit Dey, Balachandar Vellingiri, Achraf El Allali et al. · 2023 · Biomedicine & Pharmacotherapy
11. MAPPs for the identification of immunogenic hotspots of biotherapeutics; an overview of the technology and its application to the biopharmaceutical arena
    Valerie E. Quarmby, Qui T. Phung, Jennie Rebecca Lill · 2018 · Expert Review of Proteomics
12. Immunogenicity risk assessment for biotherapeutics through in vitro detection of CD134 and CD137 on T helper cells
    Sivan Cohen, Srividya Myneni, Anna R. Batt, Joyce Guerrero, Jochen Brumm, Shan Chung · 2021 · mAbs
13. The Utility of Modeling and Simulation Approaches to Evaluate Immunogenicity Effect on the Therapeutic Protein Pharmacokinetics
    Juan José Pérez Ruixo, Peiming Ma, Andrew T. Chow · 2012 · The AAPS Journal
14. Biosimilars in the therapy of inflammatory bowel diseases
    Tibor Hlavatý, Juraj Letkovský · 2014 · European Journal of Gastroenterology & Hepatology
15. Elucidation of the CHO Super-Ome (CHO-SO) by Proteoinformatics
    Amit Kumar, Deniz Baycin‐Hizal, Daniel Wolozny, Lasse Ebdrup Pedersen, Nathan E. Lewis, Kelley M. Heffner, Raghothama Chaerkady, Robert Norman Cole, Joseph Shiloach, Hui Zhang et al. · 2015 · Journal of Proteome Research
16. Aggregates of IVIG or Avastin, but not HSA, modify the response to model innate immune response modulating impurities
    Swamy Kumar Polumuri, Lydia Asrat Haile, Derek D.C. Ireland, Daniela I. Verthelyi · 2018 · Scientific Reports
17. Wechselwirkungen von Proteinen mit Polymerbeschichtungen und Biomaterialien
    Qiang Wei, Tobias Becherer, Stefano Angioletti‐Uberti, Joachim Dzubiella, Christian Wischke, Axel Thomas Neffe, Andreas Lendlein, Matthias Ballauff, Rainer Haag · 2014 · Angewandte Chemie
18. Evidence for Metabolic Cleavage of a PEGylated Protein in Vivo Using Multiple Analytical Methodologies
    Victoria L. Elliott, George T. Edge, Marie M. Phelan, Lu‐Yun Lian, Rob Webster, Rory F. Finn, B. Kevin Park, Neil R. Kitteringham · 2012 · Molecular Pharmaceutics
19. Strategic Characterization of Anti-Drug Antibody Responses for The Assessment of Clinical Relevance and Impact
    Suzanna M. Tatarewicz, Daniel T. Mytych, Marta Starcevic Manning, Steven J. Swanson, Michael S. Moxness, Narendra B. Chirmule · 2014 · Bioanalysis
20. Protein freeze concentration and micro-segregation analysed in a temperature-controlled freeze container
    Ulrich Roessl, Stefan Leitgeb, Bernd Nidetzky · 2015 · Biotechnology Reports
21. Amino acid misincorporation in recombinant proteins
    H. Edward Wong, Chung‐Jr Huang, Zhongqi Zhang · 2017 · Biotechnology Advances
22. Relationship between potential aggregation-prone regions and HLA-DR-binding T-cell immune epitopes: implications for rational design of novel and follow-on therapeutic antibodies
    Kumar, Sandeep, Mitchell, Mark A., Rup, Bonita, Singh, Satish K. · 2012 · Journal of Pharmaceutical Sciences
23. CRISPR Technologies in Chinese Hamster Ovary Cell Line Engineering
    Katja Glinšek, Krištof Bozovičar, Tomaž Bratkovič · 2023 · International Journal of Molecular Sciences
24. CMC determination of nonionic surfactants in protein formulations using ultrasonic resonance technology
    Shohei Horiuchi, Gerhard Winter · 2015 · European Journal of Pharmaceutics and Biopharmaceutics
25. Clinical testing for neutralizing antibodies to interferon-β in multiple sclerosis
    Paul I. Creeke, Rachel A Farrell · 2012 · Therapeutic Advances in Neurological Disorders
26. Measuring and Modeling Hemoglobin Aggregation below the Freezing Temperature
    Mónica Rosa, Carlos Lopes, Eduardo P. Melo, Satish Kumar Singh, Vı́tor Geraldes, Miguel Ângelo Rodrigues · 2013 · The Journal of Physical Chemistry B
27. Characterization of Drug-Product-Related Impurities and Variants of a Therapeutic Monoclonal Antibody by Higher Energy C-Trap Dissociation Mass Spectrometry
    Deyun Wang, Colin Wynne, Flora Gu, Chris Becker, Jia Zhao, Hans-Martin Mueller, Huijuan Li, Mohammed Shameem, Yan‐Hui Liu · 2014 · Analytical Chemistry
28. Cell based assay identifies TLR2 and TLR4 stimulating impurities in Interferon beta
    Lydia Asrat Haile, Swamy Kumar Polumuri, Roshni Rao, Logan Kelley-Baker, Dmitry S. Kryndushkin, Rajesh Rajaiah, Tomer Israely, V. Ashutosh Rao, Daniela I. Verthelyi · 2017 · Scientific Reports
29. Managing the Impact of Immunogenicity in an Era of Immunotherapy: From Bench to Bedside
    Katharine M. Bray, Katharina Hartman, Guido Steiner, Céline Marban-Doran, Juliana Bessa, Neil Campbell, Meret Martin‐Facklam, Kay‐Gunnar Stubenrauch, Corinne Solier, Thomas Singer et al. · 2021 · Journal of Pharmaceutical Sciences
30. Antibody adsorption on the surface of water studied by neutron reflection
    Charles Smith, Zongyi Li, Robert Holman, Fang Pan, Richard A. Campbell, Mario Campana, Peixun Li, John R. P. Webster, Steven M. Bishop, Rojaramani Narwal et al. · 2017 · mAbs
31. Immunogenicity of therapeutic peptide products: bridging the gaps regarding the role of product-related risk factors
    Montserrat Puig, Sophie Shubow · 2025 · Frontiers in Immunology
32. Immunogenicity Risk Assessment for Multi-specific Therapeutics
    Mark A. Kroenke, Mark Milton, Seema Kumar, Eris Bame, Joleen T. White · 2021 · The AAPS Journal
33. Biosimilars and biobetters as tools for understanding and mitigating the immunogenicity of biotherapeutics
    Maria D.F.S. Barbosa, Sandeep Kumar, Helen C. Loughrey, Satish Kumar Singh · 2012 · Drug Discovery Today
34. Aggregation prone regions in human proteome: Insights from large‐scale data analyses
    R. Prabakaran, Dhruv Goel, Sandeep Kumar, M. Michael Gromiha · 2017 · Proteins Structure Function and Bioinformatics
35. In silico immunogenicity assessment for sequences containing unnatural amino acids: A method using existing in silico algorithm infrastructure and a vision for future enhancements
    Aimee E. Mattei, Andrés H. Gutiérrez, William D Martin, Frances E. Terry, Brian Roberts, Amy S. Rosenberg, Anne Searls De Groot · 2022 · Frontiers in Drug Discovery
36. Online 2D-LC-MS/MS Assay To Quantify Therapeutic Protein in Human Serum in the Presence of Pre-existing Antidrug Antibodies
    Yinghua Shen, Guodong Zhang, Jinsong Yang, Yongchang Qiu, Thomas G. McCauley, Luying Pan, Jiang Wu · 2015 · Analytical Chemistry
37. Biosimilar recombinant follicle stimulating hormones in infertility treatment
    Daniele Santi, Manuela Simoni · 2014 · Expert Opinion on Biological Therapy
38. Recombinant Murine Growth Hormone Particles are More Immunogenic with Intravenous than Subcutaneous Administration
    Merry Christie, Raul Martin Torres, Ross M. Kedl, Theodore W. Randolph, John F. Carpenter · 2013 · Journal of Pharmaceutical Sciences
39. Identification of an IgG CDR sequence contributing to co‐purification of the host cell protease cathepsin D
    Jared S. Bee, L.M. Machiesky, Li Peng, Kristin C. Jusino, Matthew Dickson, Jeffrey Gill, Douglas Johnson, Hung‐Yu Lin, Kenneth Miller, Jenny Heidbrink Thompson et al. · 2016 · Biotechnology Progress
40. Advancements in Understanding Immunogenicity of Biotherapeutics in the Intraocular Space
    Eric Wakshull, Valerie E. Quarmby, Hanns‐Christian Mahler, Hongwen M. Rivers, Dhananjay Jere, Meg Ferrell Ramos, Piotr J. Szczesny, Karoline Bechtold-Peters, Sharmila Masli, Swati Gupta · 2017 · The AAPS Journal
41. Tolerogenic Nanoparticles Impacting B and T Lymphocyte Responses Delay Autoimmune Arthritis in K/BxN Mice
    Amrita Srivastava, Britni M. Arlian, Lijuan Pang, Takashi Kishimoto, James C. Paulson · 2021 · ACS Chemical Biology
42. Influence of Aggregation and Route of Injection on the Biodistribution of Mouse Serum Albumin
    Grzegorz Kijanka, Małgorzata Prokopowicz, Huub Schellekens, Vera Brinks · 2014 · PLoS ONE
43. Particle contamination of parenteralia and in-line filtration of proteinaceous drugs
    Benjamin Patrick Werner, Gerhard Winter · 2015 · International Journal of Pharmaceutics
44. Impact of Pre-Existing or Induced Anti-PEG IgM on the Pharmacokinetics of Peginterferon Alfa-2a (Pegasys) in Mice
    Nehal E. Elsadek, Eri Hondo, Taro Shimizu, Haruka Takata, Amr Selim Abu Lila, Sherif E. Emam, Hidenori Ando, Yu Ishima, Tatsuhiro Ishida · 2020 · Molecular Pharmaceutics
45. Regulatory and strategic considerations for addressing immunogenicity and related responses in biopharmaceutical development programs
    Tyler Collier Vandivort, David B. Horton, Steven B. Johnson · 2020 · Journal of Clinical and Translational Science
46. An in vitro assessment of the response of THP‐1 macrophages to varying stiffness of a glycol‐chitosan hydrogel for vocal fold tissue engineering applications
    Patrick T. Coburn, Alexandre C. Herbay, Mattia Berrini, Nicole Y. K. Li‐Jessen · 2020 · Journal of Biomedical Materials Research Part A
47. Rational optimization of a monoclonal antibody for simultaneous improvements in its solution properties and biological activity
    Sandeep Kumar, Kirk Roffi, Dheeraj S. Tomar, David J. Cirelli, Nicholas Luksha, Danielle Meyer, Jeffrey Mitchell, Martin J Allen, Li Li · 2018 · Protein Engineering Design and Selection
48. Identification of upstream culture conditions and harvest time parameters that affect host cell protein clearance
    Louis J. Wilson, Will Lewis, Richard Kucia-Tran, D. Bracewell · 2019 · Biotechnology progress (Print)
49. Electrostatic interactions modulate the differential aggregation propensities of IgG1 and IgG4P antibodies and inform charged residue substitutions for improved developability
    James T. Heads, Richard Lamb, Sebastian Kelm, Ralph Adams, Peter Elliott, Kerry L. Tyson, Sarfaraj Topia, Shauna M. West, Ruodan Nan, Alison V. Turner et al. · 2019 · Protein Engineering Design and Selection
50. The impact of the immune system on the safety and efficiency of enzyme replacement therapy in lysosomal storage disorders
    Alexander A. Broomfield, Simon Allan Jones, Stephen Miles Hughes, Brian Bigger · 2016 · Journal of Inherited Metabolic Disease
51. Determinants of immunogenic response to protein therapeutics
    Satish K. Singh, Leslie P. Cousens, David Álvarez, Pramod B. Mahajan · 2012 · Biologicals
52. Effect of Treatment Regimen on the Immunogenicity of Human Interferon Beta in Immune Tolerant Mice
    Grzegorz Kijanka, Wim Jiskoot, Huub Schellekens, Vera Brinks · 2013 · Pharmaceutical Research
53. PCR-Based Analytical Methods for Quantification and Quality Control of Recombinant Adeno-Associated Viral Vector Preparations
    Anna A. Shmidt, Tatiana V. Egorova · 2021 · Pharmaceuticals
54. Development of resistance to biologic therapies with reference to IFN-β.
    R. Farrell, M. Marta, A. Gaeguta, V. Souslova, G. Giovannoni, P. Creeke · 2012 · Rheumatology
55. Characterization of Fc-Fusion Protein Aggregates Derived from Extracellular Domain Disulfide Bond Rearrangements
    James C. Strand, Chi-Ting Huang, Jin Xu · 2012 · Journal of Pharmaceutical Sciences
56. Special endpoint and product specific considerations in pharmaceutical acceptable daily exposure derivation
    Janet C. Gould, Courtney M. Callis, David G. Dolan, Brad Stanard, Patricia A. Weideman · 2016 · Regulatory Toxicology and Pharmacology
57. Considerations when deriving compound-specific limits for extractables and leachables from pharmaceutical products: Four case studies
    Patricia Parris, Elizabeth A. Martin, Brad Stanard, Susanne Glowienke, David G. Dolan, Kim Li, Ornella Binazon, Amanda M. Giddings, Geraldine Whelan, Melisa J. Masuda-Herrera et al. · 2020 · Regulatory Toxicology and Pharmacology
58. Impact of Buffers on Colloidal Property and Aggregation Propensities of a Bispecific Antibody
    Subhabrata Majumder, Wei Wang, Arun Alphonse Ignatius · 2018 · Journal of Pharmaceutical Sciences
59. Optimizing Pharmacological and Immunological Properties of Therapeutic Proteins Through PEGylation: Investigating Key Parameters and Their Impact
    João Gonçalves, Paolo Caliceti · 2024 · Drug Design Development and Therapy
60. The Role of Aggregates of Therapeutic Protein Products in Immunogenicity: An Evaluation by Mathematical Modeling
    Liusong Yin, Xiaoying Chen, Abhinav Tiwari, Paolo Vicini, Timothy Paul Hickling · 2015 · Journal of Immunology Research
61. Key considerations in formulation development for gene therapy products
    Rafi Mohammad · 2021 · Drug Discovery Today
62. Purification and Identification of High Molecular Weight Products Formed During Storage of Neutral Formulation of Human Insulin
    Christian Fogt Hjorth, František Hubálek, Jonatan Andersson, Christian Poulsen, Daniel E. Otzen, Helle Naver · 2015 · Pharmaceutical Research
63. Comparative Evaluation of the Chemical Stability of 4 Well-Defined Immunoglobulin G1-Fc Glycoforms
    Olivier Mozziconacci, Solomon Z. Okbazghi, Apurva S. More, David B. Volkin, Thomas J. Tolbert, Christian Schöneich · 2016 · Journal of Pharmaceutical Sciences
64. Investigation of Immune Responses to Oxidation, Deamidation, And Isomerization in Therapeutic Antibodies using Preclinical Immunogenicity Risk Assessment Assays
    Rachel Zeunik, Aya F. Ryuzoji, Amber Peariso, Xiaoli Wang, Megan B. Lannan, Laura J. Spindler, Michael D. Knierman, Victoria Copeland, Chetan N. Patel, Yi Wen · 2022 · Journal of Pharmaceutical Sciences
65. Fast, robust and high-resolution glycosylation profiling of intact monoclonal IgG antibodies using nanoLC-chip-QTOF
    Joannes F.M. Jacobs, Ron A. Wevers, Dirk J. Lefeber, Monique van Scherpenzeel · 2016 · Clinica Chimica Acta
66. Analysis of glycoforms on the glycosylation site and the glycans in monoclonal antibody biopharmaceuticals
    Ebru Uçaktürk · 2011 · Journal of Separation Science
67. Local Dynamics and Their Alteration by Excipients Modulate the Global Conformational Stability of an lgG1 Monoclonal Antibody
    Santosh V. Thakkar, Jae Hyun Kim, Hardeep S. Samra, Hasige A. Sathish, Steven M. Bishop, Sangeeta B. Joshi, David B. Volkin, Charles Russell Middaugh · 2012 · Journal of Pharmaceutical Sciences
68. Evaluation of Antibody Properties and Clinically Relevant Immunogenicity, Anaphylaxis, and Hypersensitivity Reactions in Two Phase III Trials of Tralokinumab in Severe, Uncontrolled Asthma
    Mats Carlsson, Martin Braddock, Yuling Li, Jihong Wang, Weichen Xu, Nicholas White, Ayman Megally, Gillian Hunter, Gene Colice · 2019 · Drug Safety
69. Impact of a Heat Shock Protein Impurity on the Immunogenicity of Biotherapeutic Monoclonal Antibodies
    Shraddha S. Rane, Rebecca Jane Dearman, Ian Kimber, Shahid Uddin, Stephen J. Bishop, Maryam Shah, Adrian Podmore, Alain Pluen, Jeremy P. Derrick · 2019 · Pharmaceutical Research
70. A High Threshold of Biotherapeutic Aggregate Numbers is Needed to Induce an Immunogenic Response In Vitro, In Vivo, and in the Clinic
    Joseph R. Cohen, Stephen R. Brych, Siddharth Prabhu, Vivian Bi, Ahmed Elbaradei, Joshua M. Tokuda, Cathie Dong Xiang, Martha M. Hokom, Xiaohong Cui, Chau Giang Ly et al. · 2024 · Pharmaceutical Research
71. Intrinsic therapeutic and biocatalytic roles of ionic liquid mediated self-assembled platinum–phytase nanospheres
    Sarvesh Kumar Soni, Sampa Sarkar, P. R. Selvakannan, Dhiman M. Sarkar, Suresh K. Bhargava · 2015 · RSC Advances
72. Arrhenius Time-Scaled Least Squares: A Simple, Robust Approach to Accelerated Stability Data Analysis for Bioproducts
    Adam P. Rauk, Kevin Guo, Yanling Hu, Suntara Cahya, William F. Weiss · 2014 · Journal of Pharmaceutical Sciences
73. Identification and quantification of product-related quality attributes in bio-therapeutic monoclonal antibody via a simple, and robust cation-exchange HPLC method compatible with direct online detection of UV and native ESI-QTOF-MS analysis
    Praveen Kallamvalliillam Sankaran, Pradeep G. Kabadi, Chethan Gejjalagere Honnappa, Malini Subbarao, Harish V. Pai, Laxmi Adhikary, Dinesh V. Palanivelu · 2018 · Journal of Chromatography B
74. A Comparative Study to Assess the Efficacy, Safety, and Immunogenicity of YLB113 and the Etanercept Reference Product for the Treatment of Patients with Rheumatoid Arthritis
    Hisashi Yamanaka, Naoyuki Kamatani, Yoshiya Tanaka, Toshihiko Hibino, Edit Drescher, Juan Sánchez‐Bursón, Manfred Rettenbacher, Girish Bhatia, Snehal Gadve, Chirag Shah et al. · 2019 · Rheumatology and Therapy
75. The Göttingen minipig®as an alternative non-rodent species for immunogenicity testing: A demonstrator study using the IL-1 receptor antagonist anakinra
    Geertje J. D. van Mierlo, Nicole H.P. Cnubben, C. Frieke Kuper, Jasja Wolthoorn, Angelique P. van Meeteren-Kreikamp, Machiel M. Nagtegaal, Robert P. Doornbos, Niels‐Christian Ganderup, André Penninks · 2012 · Journal of Immunotoxicology
76. Assessment and significance of protein–protein interactions during development of protein biopharmaceuticals
    Sandeep Yadav, Jun Liu, Thomas Scherer, Yatin R. Gokarn, Barthélemy Demeule, Sonoko Kanai, James D. Andya, Steven J. Shire · 2013 · Biophysical Reviews
77. Comparative evaluation of the potency and antigenicity of two distinct BoNT/A-derived formulations
    Meenakshi S. Brown, Greg Nicholson, Maria C. Ardila, A. Satorius, Ron S. Broide, K. Clarke, Terrence Hunt, J. Francis · 2012 · Journal of Neural Transmission
78. Effect of metal catalyzed oxidation in recombinant viral protein assemblies
    Ricardo M. Castro‐Acosta, William A. Rodríguez‐Limas, Brenda Valderrama, Octavio T. Ramı́rez, Laura A. Palomares · 2014 · Microbial Cell Factories
79. An Integrated Analysis of Dostarlimab Immunogenicity
    Sharon M. Lu, Ronald R. Bowsher, Amanda Clancy, Amy Rosen, Mingxuan Zhang, Ying Yang, Kathleen Köeck, Minggeng Gao, Elizabeth Potocka, Wei Guo et al. · 2021 · The AAPS Journal
80. Predicting success with reduced dosing frequency of tralokinumab in patients with moderate-to-severe atopic dermatitis
    Stephan Weidinger, Anthony Bewley, H Chih-ho Hong, Juan Francisco Silvestre, Ketty Peris, Andreas Wollenberg, Ulla I. Ivens, Anders Soehoel, Louise Abildgaard Steffensen, Ann‐Marie Tindberg et al. · 2024 · British Journal of Dermatology
81. Optimization of a Raman Microscopy Technique to Efficiently Detect Amorphous–Amorphous Phase Separation in Freeze‐Dried Protein Formulations
    Kelly M. Forney‐Stevens, Michael J. Pelletier, Evgenyi Shalaev, Michael Jon Pikal, Robin H. Bogner · 2014 · Journal of Pharmaceutical Sciences
82. Glycovaccinology: The design and engineering of carbohydrate-based vaccine components
    Sophia W. Hulbert, Primit Desai, Michael C. Jewett, Matthew P. DeLisa, Asher J. Williams · 2023 · Biotechnology Advances
83. Expanding the MAPPs Assay to Accommodate MHC-II Pan Receptors for Improved Predictability of Potential T Cell Epitopes
    Katharina Hartman, Guido Steiner, Michel Siegel, Cary M. Looney, Timothy Paul Hickling, Katharine M. Bray, Sebastian Springer, Céline Marban-Doran, Axel Ducret · 2023 · Biology
84. Flow Microscopy Imaging Is Sensitive to Characteristics of Subvisible Particles in Peginesatide Formulations Associated With Severe Adverse Reactions
    Austin L. Daniels, Theodore W. Randolph · 2018 · Journal of Pharmaceutical Sciences
85. Expanding Bedside Filtration—A Powerful Tool to Protect Patients From Protein Aggregates
    Benjamin Patrick Werner, Gerhard Winter · 2018 · Journal of Pharmaceutical Sciences
86. Challenges for PEGylated Proteins and Alternative Half-Life Extension Technologies Based on Biodegradable Polymers
    Ahmed Besheer, Robert Liebner, Martin Meyer, Gerhard Winter · 2013 · ACS symposium series
87. Potential of Biosimilars to Increase Access to Biologics: Considerations for Advanced Practice Providers in Oncology
    Sara Tinsley, Carolyn Grande, CRNP, AOCNP, Karin B Olson, Leah Plato, Ira Allen Jacobs · 2018 · Journal of the Advanced Practitioner in Oncology
88. Immunogenicity of monoclonal antibody: Causes, consequences, and control strategies
    Ahmad Zafran Amin Asmani, Ahmad Faris Fahmi Zainuddin, Nadhirah Ahmad Azmi Murad, Nur Hidayati Mohd Darwis, Nur Suhaida Suhaimi, Erizal Zaini, Muhammad Taher, Deny Susanti, Junaidi Khotib · 2024 · Pathology - Research and Practice
89. Selective Domain Stabilization as a Strategy to Reduce Human Serum Albumin–Human Granulocyte Colony Stimulating Factor Aggregation Rate
    Amanda A. Cordes, John F. Carpenter, Theodore W. Randolph · 2012 · Journal of Pharmaceutical Sciences
90. Reporting, Visualization, and Modeling of Immunogenicity Data to Assess Its Impact on Pharmacokinetics, Efficacy, and Safety of Monoclonal Antibodies
    Chaitali Passey, Satyendra Suryawanshi, Kinjal Sanghavi, Manish Gupta · 2018 · The AAPS Journal
91. Amino Acid Misincorporation Propensities Revealed through Systematic Amino Acid Starvation
    H. Edward Wong, Chung‐Jr Huang, Zhongqi Zhang · 2018 · Biochemistry
92. Shape Characterization of Subvisible Particles Using Dynamic Imaging Analysis
    Roman Mathaes, Mark Cornell Manning, Gerhard Winter, Julia Engert, Glenn A. Wilson · 2019 · Journal of Pharmaceutical Sciences
93. Peptides for biopharmaceutical applications
    Dominic Agyei, Kei Xian Tan, Sharadwata Pan, Chibuike C. Udenigwe, Michael K. Danquah · 2017 · Elsevier eBooks
94. Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study
    Martin Schiestl, Nivedita Roy, Michael Trieb, Joseph P. Park, Elena Guillén, Gillian R. Woollett, Elena Wolff‐Holz · 2025 · BioDrugs
95. Monitoring size and oligomeric-state distribution of therapeutic mAbs by NMR and DLS: Trastuzumab as a case study
    Srishti Joshi, Lakshya Raj Khatri, Ashutosh Kumar, Anurag Singh Rathore · 2020 · Journal of Pharmaceutical and Biomedical Analysis
96. Review on the worldwide regulatory framework for biosimilars focusing on the Mexican case as an emerging market in Latin America
    Ricardo IbarraCabrera, Sandra Carolina Mena-Pérez, Augusto Bondani‐Guasti, Roeb García‐Arrazola · 2013 · Biotechnology Advances
97. Immunogenicity of biosimilar monoclonal antibodies
    Vera Brinks · 2013 · Generics and Biosimilars Initiative Journal
98. Monoclonal antibody higher order structure analysis by high throughput protein conformational array
    Yuanli Song, Deqiang Yu, Mukesh Mayani, Nesredin A. Mussa, Zheng Jian Li · 2018 · mAbs
99. Isotyping and Semi-Quantitation of Monkey Anti-Drug Antibodies by Immunocapture Liquid Chromatography-Mass Spectrometry
    Xiaoxiao Huang, Xiaobin Xu, Michael A. K. Partridge, Jihua Chen, Ellen M. Koehler-Stec, Giane Sumner, Haibo Qiu, Albert Torri, Ning Li · 2021 · The AAPS Journal
100. Risk-Based Comparability Assessment for Monoclonal Antibodies During Drug Development: A Clinical Pharmacology Perspective
     Yanli Zhuang, Di Chen, Amarnath Sharma, Zhenhua Xu · 2018 · The AAPS Journal