ArticleInternational journal of pharmaceutics: X2022
The effect of mAb and excipient cryoconcentration on long-term frozen storage stability - part 2: Aggregate formation and oxidation.
Article in International journal of pharmaceutics: X, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed, 14 citations in OpenAlex.
- Frozen storage of mAbs at elevated temperatures: Balancing stability and sustainability.International journal of pharmaceutics: X · 2026Article
- Effects of Siliconization Techniques, Headspace, Mechanical and Thermal Stress on Particle Generation in an Antibody Formulation.Pharmaceutical research · 2026Article
- The colder, the better? Sustainability in frozen storage of a monoclonal antibody drug substance.International journal of pharmaceutics: X · 2026Article
- Insights into Thermal Interactions in Frozen Pharmaceutical Vials: Effects on Ice Nucleation Times and Inhibition.Pharmaceutical research · 2024Article
- Characterization of Freezing Processes in Drug Substance Bottles by Ice Core Sampling.AAPS PharmSciTech · 2024Article
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Authors and funding
6 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
We examined the impact of monoclonal antibody (mAb) and buffer concentration, mimicking the cryoconcentration found upon freezing in a 2 L bottle, on mAb stability during frozen storage. Upon cryoconcentration, larger protein molecules and small excipient molecules freeze-concentrate differently, resulting in different protein to stabiliser ratios within a container. Understanding the impact of these shifted ratios on protein stability is essential. For two mAbs a set of samples with constant mAb (5 mg/mL) or buffer concentration (medium histidine/adipic acid) was prepared and stored for 6 months at -10 °C. Stability was evaluated via size-exclusion chromatography, flow imaging microscopy, UV/Vis spectroscopy at 350 nm, and protein A chromatography. Dynamic light scattering was used to determine k
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