标题
Fate of antibody and polysorbate particles in a human serum model
作者
关键词
Aggregates, In vitro, model, Monoclonal antibody, Polysorbate, Sub-visible particles
出版物
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS
Volume 171, Issue -, Pages 72-79
出版商
Elsevier BV
发表日期
2021-12-16
DOI
10.1016/j.ejpb.2021.12.005
参考文献
相关参考文献
注意:仅列出部分参考文献,下载原文获取全部文献信息。- Stability of Monoclonal Antibodies after Simulated Subcutaneous Administration
- (2021) Joachim Schuster et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Analytical Challenges Assessing Protein Aggregation and Fragmentation Under Physiologic Conditions
- (2021) Joachim Schuster et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Assessment of Antibody Stability in a Novel Protein-Free Serum Model
- (2021) Joachim Schuster et al. Pharmaceutics
- In Vivo Stability of Therapeutic Proteins
- (2020) Joachim Schuster et al. PHARMACEUTICAL RESEARCH
- Preclinical challenges for developing long acting intravitreal medicines
- (2020) Sahar Awwad et al. EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS
- Tracking the physical stability of fluorescent-labeled mAbs under physiologic in vitro conditions in human serum and PBS
- (2020) Joachim Schuster et al. EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS
- Extended Characterization and Impact of Visible Fatty Acid Particles - A Case Study With a mAb Product
- (2020) Miguel Saggu et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Impact of Precipitation of Antibody Therapeutics After Subcutaneous Injection on Pharmacokinetics and Immunogenicity
- (2019) Francis Kinderman et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Comparison of Polysorbate 80 Hydrolysis and Oxidation on the Aggregation of a Monoclonal Antibody
- (2019) Nicholas R. Larson et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Defining the right diluent for intravenous infusion of therapeutic antibodies
- (2019) Shen Luo et al. mAbs
- Use of In Vitro Systems To Model In Vivo Degradation of Therapeutic Monoclonal Antibodies
- (2018) Na Yang et al. ANALYTICAL CHEMISTRY
- Polysorbate degradation in biotherapeutic formulations: Identification and discussion of current root causes
- (2018) Mridula Dwivedi et al. INTERNATIONAL JOURNAL OF PHARMACEUTICS
- Trends on Analytical Characterization of Polysorbates and Their Degradation Products in Biopharmaceutical Formulations
- (2017) Ariadna Martos et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Fusion Proteins for Half-Life Extension of Biologics as a Strategy to Make Biobetters
- (2015) William R. Strohl BIODRUGS
- Free Fatty Acid Particles in Protein Formulations, Part 2: Contribution of Polysorbate Raw Material
- (2015) Christine C. Siska et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Dextrose-mediated aggregation of therapeutic monoclonal antibodies in human plasma: Implication of isoelectric precipitation of complement proteins
- (2015) Shen Luo et al. mAbs
- Understanding Particle Formation: Solubility of Free Fatty Acids as Polysorbate 20 Degradation Byproducts in Therapeutic Monoclonal Antibody Formulations
- (2015) Nidhi Doshi et al. MOLECULAR PHARMACEUTICS
- Identification of Subvisible Particles in Biopharmaceutical Formulations Using Raman Spectroscopy Provides Insight into Polysorbate 20 Degradation Pathway
- (2015) Miguel Saggu et al. PHARMACEUTICAL RESEARCH
- Immunogenicity of therapeutic proteins: Influence of aggregation
- (2013) Kirsty D. Ratanji et al. Journal of Immunotoxicology
- Immunogenicity of protein aggregates—Concerns and realities
- (2012) Wei Wang et al. INTERNATIONAL JOURNAL OF PHARMACEUTICS
- Protein particles: What we know and what we do not know
- (2012) Dean C. Ripple et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Detection and Characterization of Subvisible Aggregates of Monoclonal IgG in Serum
- (2012) Vasco Filipe et al. PHARMACEUTICAL RESEARCH
- Characterization of Therapeutic Monoclonal Antibodies Reveals Differences Between In Vitro and In Vivo Time-Course Studies
- (2012) Sheng Yin et al. PHARMACEUTICAL RESEARCH
- The Degradation of Polysorbates 20 and 80 and its Potential Impact on the Stability of Biotherapeutics
- (2011) Ravuri S. K. Kishore et al. PHARMACEUTICAL RESEARCH
- Fluorescence Single Particle Tracking for the Characterization of Submicron Protein Aggregates in Biological Fluids and Complex Formulations
- (2011) Vasco Filipe et al. PHARMACEUTICAL RESEARCH
- An Industry Perspective on the Monitoring of Subvisible Particles as a Quality Attribute for Protein Therapeutics
- (2010) Satish K. Singh et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Strategies for the Assessment of Protein Aggregates in Pharmaceutical Biotech Product Development
- (2010) John den Engelsman et al. PHARMACEUTICAL RESEARCH
- Identification and Localization of Unpaired Cysteine Residues in Monoclonal Antibodies by Fluorescence Labeling and Mass Spectrometry
- (2009) Chris Chumsae et al. ANALYTICAL CHEMISTRY
- A Critical Review of Methods for Size Characterization of Non-Particulate Protein Aggregates
- (2009) John Philo CURRENT PHARMACEUTICAL BIOTECHNOLOGY
- Equilibrium studies of protein aggregates and homogeneous nucleation in protein formulation
- (2009) Sylvia Kiese et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Shaken, Not Stirred: Mechanical Stress Testing of an IgG1 Antibody
- (2008) Sylvia Kiese et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- IgG particle formation during filling pump operation: A case study of heterogeneous nucleation on stainless steel nanoparticles
- (2008) Anil K. Tyagi et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Protein aggregation: Pathways, induction factors and analysis
- (2008) Hanns-Christian Mahler et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Overlooking Subvisible Particles in Therapeutic Protein Products: Gaps That May Compromise Product Quality
- (2008) John F. Carpenter et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Polysorbates 20 and 80 Used in the Formulation of Protein Biotherapeutics: Structure and Degradation Pathways
- (2007) Bruce A. Kerwin JOURNAL OF PHARMACEUTICAL SCIENCES
Find Funding. Review Successful Grants.
Explore over 25,000 new funding opportunities and over 6,000,000 successful grants.
ExploreBecome a Peeref-certified reviewer
The Peeref Institute provides free reviewer training that teaches the core competencies of the academic peer review process.
Get Started