Current and future issues in the manufacturing and development of monoclonal antibodies

Cited by (151)

Items 101–151 of 151

1. Development of Formulations for Therapeutic Monoclonal Antibodies and Fc Fusion Proteins
   Sampathkumar Krishnan, Monica M. Pallitto, Margaret Speed Ricci · 2010
2. Biosimilars: Science, Implications, and Potential Outlooks in the Middle East and Africa
   R. Batran, Mai Elmoshneb, A. S. Hussein, Omar M. Hussien, Fady Adel, Reham Elgarhy, Mosaad I. Morsi · 2022 · Biologics : Targets & Therapy
3. Neural Network to Understand Process Capability and Process Intermediates Acceptance Criteria in Monoclonal Antibody Production Process
   Ying-Fei Li, V. Venkatasubramanian · 2018 · Journal of Pharmaceutical Innovation
4. Approach to design space from retrospective quality data
   Daniel Puñal Peces, E. García-Montoya, A. Manich, J. Suñé-Negre, P. Pérez-Lozano, M. Miñarro, J. Ticó · 2016 · Pharmaceutical development and technology (Print)
5. Profiling and characterization of sialylated N-glycans by 2D-HPLC (HIAX/PGC) with online orbitrap MS/MS and offline MSn.
   A. Hanneman, J. Strand, Chi-Ting Huang · 2014 · Journal of Pharmacy and Science
6. Functional recombinant human anti-HBV antibody expressed in milk of transgenic mice
   Ran Zhang, Dan Cui, Hong Wang, Chuan Li, Xin Yao, Yaofeng Zhao, Mifang Liang, Ning Li · 2012 · Transgenic Research
7. Double promoter and tandem gene strategy for efficiently expressing recombinant FGF21
   Longying Liu, Nuoyi Ning, Simeng Xu, Dongqing Chen, Luping Zhou, Zhimou Guo, Xinmiao Liang, Xianlong Ye · 2024 · Microbial Cell Factories
8. Analyzing the dynamics of cell growth and protein production in mammalian cell fed-batch systems using logistic equations
   C. Goudar · 2012 · Journal of Industrial Microbiology & Biotechnology
9. The recombinant chimeric antibody chHAb18 against hepatocellular carcinoma can be produced in milk of transgenic mice
   Jingjing Wei, Xiangmin Yang, Ming Zheng, Mei-Li Wang, Yun-Ping Dai, Zhi-Nan Chen, Ning Li · 2011 · Transgenic research
10. Neutralizing Antibodies vs. Viruses: Interacting Mechanisms and Escape Tactics
    Hao Lu, Yichen Liu, Yue Song, Longxin Chen, Limeng Zhang, Runting Li, Xiaoning Nie, Guoqiang Zhu, Xueyan Ding, Linqing Wang · 2025 · Microorganisms
11. Machine learning-driven optimization of culture conditions and media components to mitigate charge heterogeneity in monoclonal antibody production: current advances and future perspectives
    Hossein Kavoni, Iman Shahidi Pour Savizi, Saratram Gopalakrishnan, Nathan E. Lewis, S. Shojaosadati · 2025 · mAbs
12. A Monoclonal Antibody-Based Time-Resolved Fluorescence Microsphere Lateral Flow Immunoassay for Dinotefuran and Clothianidin Detection
    Lehong Qin, Haojie Chen, Yingxiang Nie, Mengxin Zhou, Junjun Huang, Zhili Xiao · 2025 · Foods
13. A Target Affinity Enrichment Workflow to Characterize Critical Post-Translational Modifications Within Therapeutic Antibodies.
    Jethro E. Prinston, Wenjing Peng, Kathleen Provoncha, You-Mi Moon, Evan Koufos, Cristinel Sandu, Yue Fu, Yue-Tian Yan, Shun-Hai Wang, Ning Li et al. · 2025 · Journal of Pharmacy and Science
14. The Effects of Excipients on Freeze-dried Monoclonal Antibody Formulation Degradation and Sub-Visible Particle Formation during Shaking
    Meng-Jia Jin, Xin-Zhe Ge, Qiong Huang, Jia-Wei Liu, Rahul G. Ingle, D. Gao, Wei-Jie Fang · 2024 · Pharmaceutical Research
15. Generation of Nanoyeast Single-Chain Variable Fragments as High-Avidity Biomaterials for Dengue Virus Detection.
    Fahimeh Farokhinejad, R. Lane, R. Lobb, S. Edwardraja, A. Wuethrich, Christopher B. Howard, M. Trau · 2021 · ACS Biomaterials Science & Engineering
16. Characterization of proteinaceous particles in monoclonal antibody drug products using mass spectrometry.
    Xiao-Bin Xu, Qingyan Hu, Ding-Jiang Liu, Hai-Bo Qiu, M. Shameem, Ning Li · 2021 · Journal of Pharmacy and Science
17. Preformulation and Formulation of Therapeutic Peptides and Proteins
    A. Banga · 2005
18. Analytical control strategy for biologics. Part II: Roadmap for development and implementation
    Krishnan Sampathkumar, Brent S. Kendrick, John P. Gabrielson, Da Ren · 2025 · Journal of Pharmaceutical Sciences
19. The Science and Regulations of Naturally Derived Complex Drugs
    Sau Lee, A. Rosenberg, L. Walker · 2019 · AAPS Advances in the Pharmaceutical Sciences Series
20. Biologics Are Not Chemical Drugs
    J. Geigert · 2013
21. Biopharmaceuticals Are Not Chemical Drugs
    J. Geigert · 2019 · The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
22. Aptamers: Magic Bullet for Theranostic Applications
    Arghya Sett · 2020 · IntechOpen eBooks
23. Immunotargeting and therapy of cancer by advanced multivalence antibody scaffolds
    Vala Kafil, Amir Ata Saei, Mohammad Reza Tohidkia, Jaleh Barar, Yadollah Omidi · 2020 · Journal of drug targeting
24. Monitoring Quality of Critical Reagents Used in Ligand Binding Assays with Liquid Chromatography Mass Spectrometry (LC‐MS)
    Brian J. Geist, A. Clements-Egan, Tong-Yuan Yang · 2017
25. Combining measurements to estimate properties and characterization extent of complex biochemical mixtures; applications to Heparan Sulfate
    J. Pradines, D. Beccati, M. Lech, Jennifer Ozug, V. Farutin, Yong-Qing Huang, N. Gunay, I. Capila · 2016 · Scientific Reports
26. Developability Assessment Workflows to De-Risk Biopharmaceutical Development
    Jesús Zurdo, Andreas Arnell, Olga Obrezanova, Noel Smith, Thomas R. A. Gallagher, Ramón Gómez de la Cuesta, Ben Locwin · 2015 · CRC Press eBooks
27. Surrogate target cells expressing surface anti-idiotype antibody for the clinical evaluation of an internalizing CD22-specific antibody
    Shui‐on Leung, Kai Gao, Guang Yu Wang, Benny K. W. Cheung, Kwan-Yeung Lee, Qi Zhao, Wing‐Tai Cheung, Junzhi Wang · 2014 · mAbs
28. Utilization of Mass Spectrometry for the Structural Characterization of Biopharmaceutical Protein Products
    A. Lim, Catherine A. Srebalus Barnes · 2011
29. Biopharmaceuticals: Application of AUC-SV for Quantitative Analysis of Protein Size Distributions
    A. Cordes, Kelly K. Arthur, John P. Gabrielson · 2016
30. Early Characterization of Biosimilar Therapeutics
    Thomas R. Gelzleichter · 2013 · Elsevier eBooks
31. 3.45 – Follow-On Protein Products: Scientific Issues, Developments, and Challenges
    A. Rathore · 2011
32. Optimizing development of anti-TNFα biosimilars based on 10 years’ experience
    Cecil Nick · 2025 · Exploration of Musculoskeletal Diseases
33. A Comprehensive Review on Biosimilars: Present & Future
    Pratik Garai, Arindam Chakraborty, Madhumita Banerjee, P. Mukherjee · 2024 · Journal of Pharmaceutical Research International
34. Scale-up production and characterization of anti-human cardiac troponin I monoclonal antibody in ascitic fluid of balb/c mice
    Asiabanha Rezaee Majid, Rasaee Mohammad Javad, Paknejad Malihe, Mohammadnejad Javad · 2017 · Journal of immunoassay & immunochemistry
35. Recent advances in aptamer-based biosensors for viral detection
    Fu-Rong Wang, Qihan Meng, Zhimei Huang, Yi-Ming Ren, Zijie Zhang, Yang-Yang Chang, Rui Zhang, Ying-Fu Li, Jiu-Xing Li, Meng Liu · 2025 · Biocontaminant
36. Metabolomics in Animal Cell Culture
    Miroslava Čuperlović‐Culf · 2014 · Cell engineering
37. Application of Biophysics in Formulation, Process, and Product Characterization: Selected Case Studies
    Satish Kumar Singh, Qin Zou, Min Zhou Huang, Muralidhara Bilikallahalli · 2013 · Springer eBooks
38. Production of Monoclonal Antibodies in Glycoengineered Pichia pastoris
    Dongxing Zha, Thomas O. Linden, Thomas I. Potgieter · 2011 · Cell engineering
39. A Practical Roadmap for Implementing the LC-MS-Based Multi-Attribute Method for Analysis of Therapeutic Proteins
    Jing-Zhong Guo, Sheila Mugabe, Gantasala Subramanya Sameer Kumar, Vishal Amancha, Li Jing, Niomi Peckham, J. Huuskonen, Dipankar Das, D. McCarthy · 2026 · Pharmaceuticals
40. Differential immunogenicity of biosimilar monoclonal antibodies: overrated and overemphasized?
    Uwe Gudat · 2026 · Drug Discovery Today
41. The pan-variant potential of light: 425 nm light inactivates SARS-CoV-2 variants of concern and non-cytotoxic doses reduce viral titers in human airway epithelial cells
    Nathan Stasko, Leslee Arwood, Nicole Jandick, Derry Spragion, Rachel C. Roberts, Mónica Setién, Ibrahim Henson, Abigail Annas, M. Leslie Fulcher, Marisa Brotton et al. · 2025 · mSphere
42. Investigating the impact of synonymous gene recoding on a recombinantly expressed monoclonal antibody under different process parameters
    Nayiri M. Kaissarian, Stephanie L. Sandefur, Arnab Ghosh, U. Katneni, Wendy J. Walton, C. Frye, A. Komar, C. Kimchi-Sarfaty · 2025 · Bioengineering & Translational Medicine
43. Impact Factors in the Process Development for Therapeutic Antibodies
    Xiaopei Cui, Xiangyang Zhu · 2018
44. Biologic Therapies: From Complexity to Clinical Practice in a Changing Environment
    V. Lane · 2015 · EMJ Gastroenterology
45. Analytical Characterization of Proteins and Peptides
    Yajun Jennifer Wang, Brian D. Hosken · 2013 · Pharmaceutical Sciences Encyclopedia
46. Aptamer-Functionalized Nanomaterials for Cell Recognition
    Jing Zhou, Yong Wang · 2012
47. Regulatory issues in biological products
    V.P. Sangeetha, N.S. Remya, P.V. Mohanan · 2022 · Elsevier eBooks
48. Integrated Approach for Characterization of Highly Heterogeneous Drugs
    R. Raman, Z. Shriver, Thomas Clark, R. Sasisekharan · 2019 · The Science and Regulations of Naturally Derived Complex Drugs
49. Product Characterization is a Journey
    J. Geigert · 2019 · The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
50. A Systematic Framework to Optimize and Control Monoclonal Antibody Manufacturing Process
    Yunyao Li · 2018
51. Recent and Emerging Trends and Concerns Related to the Manufacturing and Testing of Monoclonal Antibodies Intended for Clinical Use
    B. Rellahan, L. Graham, D. Hirsch, S. Kennett, R. Rawat, K. Brorson, J. Swisher · 2011