Purification and Identification of High Molecular Weight Products Formed During Storage of Neutral Formulation of Human Insulin

No abstract is available for this paper.

• Publication year

  2015

• Venue

  Pharmaceutical Research

• Publication date

  2015-01-14

• Fields of study

  Medicine, Chemistry

• Identifiers
  DOI 10.1007/s11095-014-1600-3PMID 25583030
• External record

  Open on Semantic Scholar

• Source metadata

  Semantic Scholar, PubMed

• No claims are published for this paper.

• No concepts are published for this paper.

• Effects of phenol and meta-cresol depletion on insulin analog stability at physiological temperature.

  2014cited by this paper
• Protein instability and immunogenicity: roadblocks to clinical application of injectable protein delivery systems for sustained release.

  2012cited by this paper
• Chemical Modifications in Aggregates of Recombinant Human Insulin Induced by Metal-Catalyzed Oxidation: Covalent Cross-Linking via Michael Addition to Tyrosine Oxidation Products

  2012cited by this paper
• Simultaneous detection and analysis of protein aggregation and protein unfolding by size exclusion chromatography with post column addition of the fluorescent dye BisANS.

  2012cited by this paper
• Forced degradation of therapeutic proteins.

  2012cited by this paper
• Kinetics and Mechanisms of Deamidation and Covalent Amide-Linked Adduct Formation in Amorphous Lyophiles of a Model Asparagine-Containing Peptide

  2011cited by this paper
• Oxidized and Aggregated Recombinant Human Interferon Beta is Immunogenic in Human Interferon Beta Transgenic Mice

  2011cited by this paper
• Impact of product-related factors on immunogenicity of biotherapeutics.

  2011cited by this paper
• An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics.

  2010cited by this paper
• Elution behavior of insulin on high-performance size exclusion chromatography at neutral pH.

  2010cited by this paper
• Stability of Protein Pharmaceuticals: An Update

  2010cited by this paper
• Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality.

  2009cited by this paper
• Effect of Ethylenediamine on Chemical Degradation of Insulin Aspart in Pharmaceutical Solutions

  2008cited by this paper
• Altered immunogenicity of isoaspartate containing proteins

  2007cited by this paper
• Effects of protein aggregates: An immunologic perspective

  2006cited by this paper
• Asparagine deamidation: pH-dependent mechanism from density functional theory.

  2006cited by this paper
• Antibody response to aggregated human interferon alpha2b in wild-type and transgenic immune tolerant mice depends on type and level of aggregation.

  2006cited by this paper
• Protein drug stability: a formulation challenge

  2005cited by this paper
• Thermal dissociation and unfolding of insulin.

  2005cited by this paper
• Structure-Immunogenicity Relationships of Therapeutic Proteins

  2004cited by this paper
• Insulin Aspart (AspB28 Human Insulin) Derivatives Formed in Pharmaceutical Solutions

  2002cited by this paper
• Instability, stabilization, and formulation of liquid protein pharmaceuticals.

  1999cited by this paper
• Effects of Insulin Concentration and Self-Association on the Partitioning of Its A-21 Cyclic Anhydride Intermediate to Desamido Insulin and Covalent Dimer

  1995cited by this paper
• Evidence for a common intermediate in insulin deamidation and covalent dimer formation: effects of pH and aniline trapping in dilute acidic solutions.

  1995cited by this paper
• The Role of Intramolecular Nucleophilic Catalysis and the Effects of Self-Association on the Deamidation of Human Insulin at Low pH

  1994cited by this paper
• Immunogenicity and Allergenic Potential of Animal and Human Insulins

  1993cited by this paper
• Chemical stability of insulin. 3. Influence of excipients, formulation, and pH.

  1992cited by this paper
• Improved insulin stability through amino acid substitution.

  1992cited by this paper
• Chemical Stability of Insulin. 2. Formation of Higher Molecular Weight Transformation Products During Storage of Pharmaceutical Preparations

  1992cited by this paper
• Chemical stability of insulin. 5. Isolation, characterization and identification of insulin transformation products.

  1992cited by this paper
• Persistent Cutaneous Insulin Allergy Resulting From High-Molecular-Weight Insulin Aggregates

  1990cited by this paper
• Comparison of solution structural flexibility and zinc binding domains for insulin, proinsulin, and miniproinsulin.

  1989cited by this paper
• Phenol stabilizes more helix in a new symmetrical zinc insulin hexamer

  1989cited by this paper
• Soluble, prolonged-acting insulin derivatives. III. Degree of protraction, crystallizability and chemical stability of insulins substituted in positions A21, B13, B23, B27 and B30.

  1988cited by this paper
• Deamidation, isomerization, and racemization at asparaginyl and aspartyl residues in peptides. Succinimide-linked reactions that contribute to protein degradation.

  1987cited by this paper
• Free Covalent Aggregates of Therapeutic Insulin in Blood of Insulin-Dependent Diabetics

  1987cited by this paper
• The source of the circulating aggregate of insulin in type I diabetic patients is therapeutic insulin.

  1986cited by this paper
• Relationship of structure to biological activity of insulin as revealed by degradative studies.

  1966cited by this paper

• Creating Glepaglutide, the First Long-Acting GLP-2 Analogue to Enable a Ready-to-Use Injection.

  2025cites this paper
• Anti-diabetic Biologicals: Exploring the Role of Different Analytical Techniques.

  2025cites this paper
• Comparative physicochemical and structural characterisation studies establish high biosimilarity between BGL-ASP and reference insulin aspart

  2024cites this paper
• From cell factories to patients: Stability challenges in biopharmaceuticals manufacturing and administration with mitigation strategies.

  2023cites this paper
• Formation of subvisible particles in commercial insulin formulations.

  2022cites this paper
• Long-Term Stability Prediction for Developability Assessment of Biopharmaceutics Using Advanced Kinetic Modeling

  2022cites this paper
• In vitro and in vivo immunogenicity assessment of protein aggregate characteristics

  2022cites this paper
• Behavior of Regular Insulin in a Parenteral Nutrition Admixture: Validation of an LC/MS-MS Assay and the In Vitro Evaluation of Insulin Glycation

  2022cites this paper
• Spray Freeze Dried Lyospheres® for Nasal Administration of Insulin

  2021cites this paper
• Spontaneous Breakdown of Long‐Lived Proteins in Aging and Their Implications in Disease

  2021cites this paper
• Large scale purification and characterization of A21 deamidated variant-most prominent Post Translational Modification (PTM) for insulins which is also widely observed in insulins pharmaceutical manufacturing and storage.

  2021cites this paper
• Simultaneous characterization of insulin HMWP and protamine sulphate in complex formulations through SEC-coupled mass spectrometry.

  2021cites this paper
• The Peptide Ligase Activity of Human Legumain Depends on Fold Stabilization and Balanced Substrate Affinities

  2021cites this paper
• Characterization of Insulin Dimers by Top-Down Mass Spectrometry.

  2020cites this paper
• Mechanism of protein cleavage at asparagine leading to protein-protein crosslinks.

  2019cites this paper
• Protein aggregation - Mechanisms, detection, and control.

  2018cites this paper
• Identification of N-Terminally Truncated Derivatives of Insulin Analogs Formed in Pharmaceutical Formulations

  2018cites this paper
• Challenges with osmolytes as inhibitors of protein aggregation: Can nucleic acid aptamers provide an answer?

  2017cites this paper
• Insulin Formulation Characterization—the Thioflavin T Assays

  2017influential citation
• Structure, Aggregation, and Activity of a Covalent Insulin Dimer Formed During Storage of Neutral Formulation of Human Insulin.

  2016cites this paper