ArticlePharmaceutical research2020
Influence of Production Process and Scale on Quality of Polypeptide Drugs: a Case Study on GLP-1 Analogs.
Article in Pharmaceutical research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Who cites it
17 citing papers in PubMed, 34 citations in OpenAlex.
- Anisotropic Electrostatics in the Instability of GLP‑1 Analog Micelles: Effects of Electrolytes, Denaturants, pH, and Temperature.ACS omega · 2026Article
- Original rDNA Semaglutide Versus Synthetic Copies: Differences and Clinical Implications.Cureus · 2026Article
- Impurities and Potential Immunogenicity Associated With Follow-on and Compounded Glucagon-like Peptide-1 Receptor Agonists.Pharmaceutical research · 2026Article
- Combined use of glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter 2 inhibitors for cardiovascular protection.Indian journal of pharmacology · 2026Review
- Semaglutide and Follow-On Peptide Therapeutics: Balancing Innovation, Regulation, and Clinical Outcomes.Cureus · 2026Review
- Resistant and Refractory Obesity: The Complexity of Anti-Obesity Therapy Failure.International journal of molecular sciences · 2026Review
- Semaglutide - properties, action and chromatographic analysis.Journal of diabetes and metabolic disorders · 2025Review
- Improving sensitivity and drug tolerance of assays for neutralizing anti-drug antibodies to semaglutide and native GLP-1.Bioanalysis · 2025Article
- Dissecting Hidden Liraglutide Oligomerization Pathways via Direct Mass Technology, Electron-Capture Dissociation, and Molecular Dynamics.Analytical chemistry · 2025Article
- Immunogenicity of Generic Peptide Impurities: Current Orthogonal Approaches.Pharmaceutical research · 2025Article
- Effect of Lipidation on the Structure, Oligomerization, and Aggregation of Glucagon-like Peptide 1.Bioconjugate chemistry · 2025Article
- Integration of Glucagon-Like Peptide 1 Receptor Actions Through the Central Amygdala.Endocrinology · 2025Review
- Yeast as a tool for exploring disulfide-rich peptides.FEMS yeast research · 2025Review
- Impact of Manufacturing Process and Compounding on Properties and Quality of Follow-On GLP-1 Polypeptide Drugs.Pharmaceutical research · 2024Article
- Influence of Trp-Cage on the Function and Stability of GLP-1R Agonist Exenatide Derivatives.Journal of medicinal chemistry · 2024Article
- Surface-mediated spontaneous emulsification of the acylated peptide, semaglutide.Proceedings of the National Academy of Sciences of the United States of America · 2024Article
- Synthetic polypeptides using a biologic as a reference medicinal product - the European landscape of regulatory approvals.Frontiers in medicine · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeManufacturing processes for polypeptide/protein drugs are designed to ensure robust quality, efficacy and safety. Process differences introduced by follow-on manufacturers may result in changes in quality and clinical outcomes. This study investigated the impact of production methods on the stability and impurities of liraglutide and semaglutide drug substances/products, and the potential impact on drug quality, efficacy and safety.
methodsState-of-the-art analytical methods were used to compare physical and chemical stability, and impurity profiles of drug substances/products from different suppliers. Identified polypeptide-related impurities were evaluated for immunogenicity potential by in silico T cell epitope prediction. Semaglutide immunogenicity in clinical trials (SUSTAIN) was evaluated using a tiered antibody analysis.
resultsManufacturing scale and process strongly impacted the physical stability of the products. Trace metals increased high-molecular-weight protein formation for liraglutide and semaglutide. Synthetic and recombinant liraglutide produced by five suppliers had distinct impurity profiles compared with the originator. In silico evaluation suggested that new impurities could be immunogenic. Immunogenicity of semaglutide in clinical trials was lower than for liraglutide.
conclusionsDifferences in manufacturing processes affect chemical/physical stability and impurity profile, and may impact immunogenicity. Follow-on versions of liraglutide and semaglutide, and possibly other polypeptides, should be clinically evaluated for efficacy and safety.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.