ReviewPharmaceutics2022
Alternative Excipients for Protein Stabilization in Protein Therapeutics: Overcoming the Limitations of Polysorbates.
Review in Pharmaceutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers.
What it found
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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.
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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
37 citing papers in PubMed, 73 citations in OpenAlex.
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- Mechanistic investigation of sucrose monostearate-mediated antifungal effects against Penicillium oxalicum.Archives of microbiology · 2026Article
- Recombinant Protein Drugs: A 2025 Update.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Review
- Advanced Proteomic Profiling Demonstrates Clinical Utility of Patient-Centric, at-Home Dried Blood Sample Collection.Journal of proteome research · 2026Article
- From permeation enhancer to therapeutic enabler: Advances, applications, and translational perspectives in hyaluronidase-based drug delivery.Materials today. Bio · 2026Review
- Host cell protein impurities in therapeutic proteins: overview of advances in detection, nonconventional removal technologies and immunogenicity assessment.Journal of biological engineering · 2026Review
- Engineering Liposomes and Polymer Conjugates: A Platform for Mechanistic Complement Activation Studies and Controlled Release Applications.ACS applied materials & interfaces · 2026Article
- Modulation of Intravenous Immunoglobulin Aggregation, Subvisible Particle Formation, and Viscosity by Acetylated Amino Acids.Pharmaceutics · 2026Article
- Phosphatidylcholine-Polysorbate 20-Based Mixed Micelles: A New Option to Prevent Protein Aggregation?Pharmaceutics · 2026Article
- Article
- Purification, characterization, and anticoagulant mechanism of an anticoagulant protein from marineFrontiers in microbiology · 2026Article
- Hydrophilic Poly(Iminopyridinium Ylide)s: Defining a New Chemical Space for Poly(ylide)s.Macromolecular rapid communications · 2026Article
- Monoclonal antibody formulations: a quantitative analysis of marketed products and patents.mAbs · 2025Article
- Article
- Exploring the effects of excipients on complex coacervation.Journal of colloid and interface science · 2025Article
- Engineering a BMP2-risedronate complex with sustained release for osteoporosis therapy.Archives of pharmacal research · 2025Article
- In Situ Forming Poloxamer-Based Thermo-Sensitive Hydrogels for Ocular Application: A Focus on the Derivatives 407 and 188.Gels (Basel, Switzerland) · 2025Review
- Formulation of Recombinant Therapeutic Proteins: Technological Innovation, Regulations, and Evolution Towards Buffer-Free Formulations.Pharmaceutics · 2025Review
- Physicochemical Comparison of Kolliphor HS 15, ELP, and Conventional Surfactants for Antibody Stabilization in Biopharmaceutical Formulations.Molecular pharmaceutics · 2025Article
- Opportunities in formulation development of antibody-based therapeutics.Antibody therapeutics · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Given their safety and efficiency in protecting protein integrity, polysorbates (PSs) have been the most widely used excipients for the stabilization of protein therapeutics for years. In recent decades, however, there have been numerous reports about visible or sub-visible particles in PS-containing biotherapeutic products, which is a major quality concern for parenteral drugs. Alternative excipients that are safe for parenteral administration, efficient in protecting different protein drugs against various stress conditions, effective in protein stabilization in high-concentrated liquid formulations, stable under the storage conditions for the duration of the product's shelf-life, and compatible with other formulation components and the primary packaging are highly sought after. The aim of this paper is to review potential alternative excipients from different families, including surfactants, carbohydrate- and amino acid-based excipients, synthetic amphiphilic polymers, and ionic liquids that enable protein stabilization. For each category, important characteristics such as the ability to stabilize proteins against thermal and mechanical stresses, current knowledge related to the safety profile for parenteral administration, potential interactions with other formulation components, and primary packaging are debated. Based on the provided information and the detailed discussion thereof, this paper may pave the way for the identification or development of efficient excipients for biotherapeutic protein stabilization.
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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.