ArticlePharmaceutical research2018
Impact of Buffer, Protein Concentration and Sucrose Addition on the Aggregation and Particle Formation during Freezing and Thawing.
Article in Pharmaceutical research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 19 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed.
- Frozen storage of mAbs at elevated temperatures: Balancing stability and sustainability.International journal of pharmaceutics: X · 2026Article
- 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
- CRISPR-Cas systems for plant virus management: detection, surveillance, and host resistance.Frontiers in plant science · 2026Review
- mRNA vaccines: immunogenicity and quality characteristics.Journal of nanobiotechnology · 2025Review
- Glucose-Enhanced Cryopreservation of hCAR-T Cells: Improved Recovery and Reduced Apoptosis.Biomolecules & therapeutics · 2025Article
- Influence of expression and purification protocols on Gα biochemical activity: kinetics of plant and mammalian G protein cycles.Frontiers in molecular biosciences · 2025Article
- The Effects of Excipients on Freeze-dried Monoclonal Antibody Formulation Degradation and Sub-Visible Particle Formation during Shaking.Pharmaceutical research · 2024Article
- Study of Oncolytic Virus Preservation and Formulation.Pharmaceuticals (Basel, Switzerland) · 2023Review
- The effect of mAb and excipient cryoconcentration on long-term frozen storage stability - part 2: Aggregate formation and oxidation.International journal of pharmaceutics: X · 2022Article
- The effect of mAb and excipient cryoconcentration on long-term frozen storage stability - Part 1: Higher molecular weight species and subvisible particle formation.International journal of pharmaceutics: X · 2022Article
- Improved Purification of Human Granzyme A/B and Granulysin Using a Mammalian Expression System.Frontiers in immunology · 2022Article
- Solubilization and Refolding of Inclusion Body Proteins.Methods in molecular biology (Clifton, N.J.) · 2022Article
- Development and Application of a Mechanistic Cooling and Freezing Model of the Spin Freezing Step within the Framework of Continuous Freeze-Drying.Pharmaceutics · 2021Article
- Photosystem I integrated into mesoporous microspheres has enhanced stability and photoactivity in biohybrid solar cells.Materials today. Bio · 2021Article
- Influence of bound dodecanoic acid on the reconstitution of albumin nanoparticles from a lyophilized state.Scientific reports · 2021Article
- Cryoconcentration and 3D Temperature Profiles During Freezing of mAb Solutions in Large-Scale PET Bottles and a Novel Scale-Down Device.Pharmaceutical research · 2020Article
- Review
- Article
Corrections and comments
- Erratum issued
Authors and funding
6 authors.
Funding
Abstract
purposeThis study addresses the effect of freezing and thawing on a therapeutic monoclonal antibody (mAb) solution and the corresponding buffer formulation. Particle formation, crystallization behaviour, morphology changes and cryo-concentration effects were studied after varying the freezing and thawing rates, buffer formulation and protein concentration. The impact of undergoing multiple freeze/thaw (FT)-cycles at controlled and uncontrolled temperature rates on mAb solutions was investigated in terms of particle formation.
methodsPhysicochemical characteristics were analysed by Differential Scanning Calorimetry whereas morphology changes are visualized by cryomicroscopy measurements. Micro Flow Imaging, Archimedes and Dynamic Light Scattering were used to investigate particle formation.
resultsData retrieved in the present study emphasizes the damage caused by multiple FT-cyles and the need for sucrose as a cryoprotectant preventing cold-crystallization specifically at high protein concentrations. Low protein concentrations cause an increase of micron particle formation. Low freezing rates lead to a decreased particle number with increased particle diameter.
conclusionThe overall goal of this research is to gain a better understanding of the freezing and thawing behaviour of mAb solutions with the ultimate aim to optimize this process step by reducing the unwanted particle formation, which also includes protein aggregates.
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What OpenQuestion holds
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.