ArticleInternational journal of pharmaceutics: X2022
The effect of mAb and excipient cryoconcentration on long-term frozen storage stability - Part 1: Higher molecular weight species and subvisible particle formation.
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 8 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.
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
8 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
- Quality by Design to Mitigate Aggregation: Mechanistic Insights and Analytical Strategies for Biopharmaceutical Manufacturing.Therapeutic innovation & regulatory science · 2026Review
- The colder, the better? Sustainability in frozen storage of a monoclonal antibody drug substance.International journal of pharmaceutics: X · 2026Article
- Managing Dissolved Air Throughout Freeze-Thaw Process to Reduce Aggregation of Human Serum Albumin.AAPS PharmSciTech · 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
- Study of Oncolytic Virus Preservation and Formulation.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Review
Corrections and comments
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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
Cryoconcentration upon large-scale freezing of monoclonal antibody (mAb) solutions leads to regions of different ratios of low molecular weight excipients, like buffer species or sugars, to protein. This study focused on the impact of the buffer species to mAb ratio on aggregate formation after frozen storage at -80 °C, -20 °C, and - 10 °C after 6 weeks, 6 months, and 12 months. An optimised sample preparation was established to measure T
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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.