ArticleInternational journal of pharmaceutics2014
The effect of arginine glutamate on the stability of monoclonal antibodies in solution.
Article in International journal of pharmaceutics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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Who cites it
19 citing papers in PubMed.
- Impact of Amino Acid Excipients on icIEF Method Development in Protein Therapeutics: A Formulation-Aware Analytical Framework.AAPS PharmSciTech · 2026Article
- Bayesian Optimization for Efficient Multiobjective Formulation Development of Biologics.Molecular pharmaceutics · 2025Article
- A Review on the Stability Challenges of Advanced Biologic Therapeutics.Pharmaceutics · 2025Review
- PK/PD of Positively Charged ADC in Mice.Pharmaceutics · 2025Article
- Phenylalanine as an effective stabilizer and aggregation inhibitor of Bacillus amyloliquefaciens alpha-amylase.AMB Express · 2024Article
- Understanding the Specific Implications of Amino Acids in the Antibody Development.The protein journal · 2024Review
- Effects of arginine in therapeutic protein formulations: a decade review and perspectives.Antibody therapeutics · 2023Review
- Analytical Workflows to Unlock Predictive Power in Biotherapeutic Developability.Pharmaceutical research · 2023Article
- Amino acid-mPEGs: Promising excipients to stabilize human growth hormone against aggregation.Iranian journal of basic medical sciences · 2023Article
- Prediction of Drug Stability Using Deep Learning Approach: Case Study of Esomeprazole 40 mg Freeze-Dried Powder for Solution.Pharmaceutics · 2021Article
- Formulation strategies in immunotherapeutic pharmaceutical products.World journal of clinical oncology · 2020Review
- Article
- FTIR Spectroscopic Study of the Secondary Structure of Globular Proteins in Aqueous Protic Ionic Liquids.Frontiers in chemistry · 2019Article
- An Evaluation of the Potential of NMR Spectroscopy and Computational Modelling Methods to Inform Biopharmaceutical Formulations.Pharmaceutics · 2018Review
- Viscosity Control of Protein Solution by Small Solutes: A Review.Current protein & peptide science · 2018Review
- Article
- The effects of arginine glutamate, a promising excipient for protein formulation, on cell viability: Comparisons with NaCl.Toxicology in vitro : an international journal published in association with BIBRA · 2016Article
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- Article
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Authors and funding
7 authors.
Funding
Abstract
Finding excipients which mitigate protein self-association and aggregation is an important task during formulation. Here, the effect of an equimolar mixture of l-Arg and l-Glu (Arg·Glu) on colloidal and conformational stability of four monoclonal antibodies (mAb1-mAb4) at different pH is explored, with the temperatures of the on-set of aggregation (Tagg) and unfolding (Tm1) measured by static light scattering and intrinsic fluorescence, respectively. Arg·Glu increased the Tagg of all four mAbs in concentration-dependent manner, especially as pH increased to neutral. Arg·Glu also increased Tm1 of the least thermally stable mAb3, but without similar direct effect on the Tm1 of other mAbs. Raising pH itself from 5 to 7 increased Tm1 for all four mAbs. Selected mAb formulations were assessed under accelerated stability conditions for the monomer fraction remaining in solution after storage. The aggregation of mAb3 was suppressed to a greater extent by Arg·Glu than by Arg·HCl. Furthermore, Arg·Glu suppressed the aggregation of mAb1 at neutral pH such that the fraction monomer was near to that at the more typical formulation pH of 5.5. We conclude that Arg·Glu can suppress mAb aggregation with increasing temperature/pH and, importantly, under accelerated stability conditions at weakly acidic to neutral pH.
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