ReviewAntibody therapeutics2022
The measurement and control of high-risk host cell proteins for polysorbate degradation in biologics formulation.
Review in Antibody therapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
What it found
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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
20 citing papers in PubMed, 58 citations in OpenAlex.
- Host cell protein impurities in therapeutic proteins: overview of advances in detection, nonconventional removal technologies and immunogenicity assessment.Journal of biological engineering · 2026Review
- Application of a novel LC-MS-based proteomic workflow for host cell protein monitoring and risk control in biotherapeutics.Antibody therapeutics · 2026Article
- Phosphatidylcholine-Polysorbate 20-Based Mixed Micelles: A New Option to Prevent Protein Aggregation?Pharmaceutics · 2026Article
- Characterization of difficult-to-remove host cell proteins in adeno-associated virus downstream processing.Molecular therapy. Methods & clinical development · 2025Article
- Host Cell Protein Clinical Safety Risk Assessment-An Updated Industry Review.Biotechnology and bioengineering · 2025Review
- Utilizing Octanoic Acid to Quantitatively Assess the Oxidation Status of PS80.Pharmaceutical research · 2025Article
- Activity-Based Protein Profiling of Active Host Cell Serine Hydrolases for Bioprocess Development of Therapeutic Proteins and Vaccines.Methods in molecular biology (Clifton, N.J.) · 2025Article
- Characterization of host cell proteins in the downstream process of plant-Based biologics using LC-MS profiling.Biotechnology reports (Amsterdam, Netherlands) · 2024Article
- High-Throughput Fluorometric Assay For Quantifying Polysorbate In Biopharmaceutical Products Using Micelle Activated Fluorescence Probe N-Phenyl-1-Naphthylamine.Pharmaceutical research · 2024Article
- Quantitation of Host Cell Proteins by Capillary LC/IMS/MS/MS in Combination with Rapid Digestion on Immobilized Trypsin Column Under Native Conditions.Mass spectrometry (Tokyo, Japan) · 2024Article
- Polysorbates degrading enzymes in biotherapeutics - a current status and future perspectives.Frontiers in bioengineering and biotechnology · 2024Review
- Oxidation of polysorbates - An underestimated degradation pathway?International journal of pharmaceutics: X · 2023Review
- Comparative Stability Study of Polysorbate 20 and Polysorbate 80 Related to Oxidative Degradation.Pharmaceutics · 2023Article
- End-to-End Approach to Surfactant Selection, Risk Mitigation, and Control Strategies for Protein-Based Therapeutics.The AAPS journal · 2022Article
- Alternative Excipients for Protein Stabilization in Protein Therapeutics: Overcoming the Limitations of Polysorbates.Pharmaceutics · 2022Review
- Standard-Free Absolute Quantitation of Antibody Deamidation Degradation and Host Cell Proteins by Coulometric Mass Spectrometry.Analytical chemistry · 2022Article
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- Proteomics-based method to comprehensively model the removal of host cell protein impurities.Biotechnology progressArticle
Corrections and comments
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Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Nonionic surfactant polysorbates, including PS-80 and PS-20, are commonly used in the formulation of biotherapeutic products for both preventing surface adsorption and acting as stabilizer against protein aggregation. Trace levels of residual host cell proteins (HCPs) with lipase or esterase enzymatic activity have been shown to degrade polysorbates in biologics formulation. The measurement and control of these low abundance, high-risk HCPs for polysorbate degradation are an industry-wide challenge to achieve desired shelf life of biopharmaceuticals in liquid formulation, especially for high-concentration formulation product development. Here, we reviewed the challenges, recent advances, and future opportunities of analytical method development, risk assessment, and control strategies for polysorbate degradation during formulation development with a focus on enzymatic degradation. Continued efforts to advance our understanding of polysorbate degradation in biologics formulation will help develop high-quality medicines for patients.
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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.