ArticleJournal of pharmaceutical sciences2020
Comparison of Strategies in Development and Manufacturing of Low Viscosity, Ultra-High Concentration Formulation for IgG1 Antibody.
Article in Journal of pharmaceutical sciences, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
13 citing papers in PubMed, 29 citations in OpenAlex.
- Enhancing Bioavailability of Ultra-High Concentration Antibody Formulations Using Ionic Liquids.Advanced healthcare materials · 2026Article
- Binding of Tetrachloroaurate(III) to Bovine or Human γ-Globulins.International journal of molecular sciences · 2026Article
- S.C. delivery of ultra-high concentration (up to 500 mg/mL) protein microparticle suspensions: pharmacokinetics, efficacy, biodistribution, and immunogenicity.Drug delivery and translational research · 2026Article
- Review
- Ultrahigh-concentration biologic therapeutics enabled by spray drying with a glassy surfactant excipient.Science translational medicine · 2025Article
- Engineering Considerations for Developing Next-Generation Oligonucleotide Therapeutics.Nature chemical engineering · 2024Article
- Stability of Protein Pharmaceuticals: Recent Advances.Pharmaceutical research · 2024Review
- Poly(glutamic acid)-Based Viscosity Reducers for Concentrated Formulations of a Monoclonal IgG Antibody.Molecular pharmaceutics · 2024Article
- The Osmolality and Hemolysis of High-Concentration Monoclonal Antibody Formulations.Pharmaceutical research · 2024Article
- US FDA-approved therapeutic antibodies with high-concentration formulation: summaries and perspectives.Antibody therapeutics · 2021Review
- Article
- Review
- Variable domain mutational analysis to probe the molecular mechanisms of high viscosity of an IgGmAbsArticle
Corrections and comments
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Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Monoclonal antibodies requiring higher doses for exerting therapeutic effect but having lower stability, are administered as dilute infusions, or as two (low concentration) injections both resulting in reduced patient compliance. Present research summarizes impact of manufacturing conditions on ultra-high concentration (≥150 mg/mL) IgG1 formulation, which can be administered as one subcutaneous injection. IgG1 was concentrated to ~200 mg/mL using tangential flow filtration (TFF). Alternatively, spray dried (SPD) and spray freeze dried (SFD) IgG1, was reconstituted in 30%v/v propylene glycol to form ultra-high concentration (~200 mg/mL) injectable formulation. Reconstituted, SPD and SFD IgG1 formulations, increased viscosity beyond an acceptable range for subcutaneous injections (<20 cP). Formulations developed by reconstitution of SPD IgG1, demonstrated increase in high and low molecular weight impurities, at accelerated and stressed conditions. Whereas, the stability data suggested reconstituted SFD IgG1 was comparable to control IgG1 formulation concentrated by TFF. Also, formulation of IgG1 diafiltered with proline using TFF, reduce viscosity from ~21.9 cP to ~11 cP at 25 °C and had better stability. Thus, conventional TFF technique stands to be one of the preferred methods for manufacturing of ultra-high concentration IgG1 formulations. Additionally, SFD could be an alternative method for long term storage of IgG1 in a dry powder state.
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Registered trials
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