ArticleThe AAPS journal2014
Analyzing subvisible particles in protein drug products: a comparison of dynamic light scattering (DLS) and resonant mass measurement (RMM).
Article in The AAPS journal, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.
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Who cites it
26 citing papers in PubMed.
- Optical imaging and spectroscopic characterization of subvisible particles in protein therapeutics.Advanced drug delivery reviews · 2026Review
- Nano-PhotoCrystals (Photosensitive Nanocrystals) of Aloe Emodin Combined with Dissolving Microneedles for Dual Smart Targeting of Acute Bacterial Skin and Soft Tissue Infections.ACS applied materials & interfaces · 2025Article
- Unraveling the Effects of Filtration, Process Interruptions, and Post-Process Agitation on Protein Aggregation.AAPS PharmSciTech · 2025Article
- Aptamer-guided graphene oxide quantum dots for targeted suicide gene therapy in an organoid model of luminal breast cancer.Scientific reports · 2024Article
- Gums as Macromolecular Crowding Agents in Human Skin Fibroblast Cultures.Life (Basel, Switzerland) · 2024Article
- Multiple Natural Polymers in Drug and Gene Delivery Systems.Current medicinal chemistry · 2024Review
- Effects of Gas Type, Oil, Salts and Detergent on Formation and Stability of Air and Carbon Dioxide Bubbles Produced by Using a Nanobubble Generator.Nanomaterials (Basel, Switzerland) · 2023Article
- α-Synuclein Preformed Fibrils Bind to β-Neurexins and Impair β-Neurexin-Mediated Presynaptic Organization.Cells · 2023Article
- Evaluation and Screening of Biopharmaceuticals using Multi-Angle Dynamic Light Scattering.AAPS PharmSciTech · 2023Article
- Article
- An Interlaboratory Comparison on the Characterization of a Sub-micrometer Polydisperse Particle Dispersion.Journal of pharmaceutical sciences · 2022Article
- Optimized Production of Fc Fusion Proteins by Sortase Enzymatic Ligation.Industrial & engineering chemistry research · 2021Article
- Nanoformulation and Evaluation of Oral Berberine-Loaded Liposomes.Molecules (Basel, Switzerland) · 2021Article
- Article
- Particle Detection and Characterization for Biopharmaceutical Applications: Current Principles of Established and Alternative Techniques.Pharmaceutics · 2020Review
- Features of Sizing and Enumeration of Silica and Polystyrene Nanoparticles by Nanoparticle Tracking Analysis (NTA).Sensors (Basel, Switzerland) · 2020Article
- Bacterial Quorum Sensing Signals Self-Assemble in Aqueous Media to Form Micelles and Vesicles: An Integrated Experimental and Molecular Dynamics Study.The journal of physical chemistry. B · 2020Article
- Effect of Arginine on Chaperone-Like Activity of HspB6 and Monomeric 14-3-3ζ.International journal of molecular sciences · 2020Article
- Dynamic Light Scattering of Biopharmaceutics-Can Analytical Performance Be Enhanced by Laser Power?Pharmaceutics · 2018Article
- Development of orthogonal NISTmAb size heterogeneity control methods.Analytical and bioanalytical chemistry · 2018Article
Corrections and comments
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Authors and funding
4 authors.
Funding
Abstract
Aggregation is common in protein drug manufacture, and while the effects of protein particulates are under investigation, many techniques applicable for their characterization have been recently developed. Among the methods available to characterize and quantify protein aggregates, none is applicable over the full size range and different methods often give conflicting results. The studies presented here compare two such methods: dynamic light scattering (DLS) and resonant mass measurement (RMM). The performance of each method was first characterized using polystyrene particle size standards (20, 60, 100, 200, 400, and 1,000 nm) over a range of concentrations. Standard particles were measured both singly and in binary mixtures containing 20 nm particles at a fixed concentration (10(14) particles/mL) and various concentrations of one of the other particle sizes (i.e., 60, 100, 200, 400, or 1,000 nm). DLS and RMM were then used to detect unknown aggregate content in stressed samples of IgG. Both instruments were shown to have a working range that depends on particle size and concentration. In binary mixtures and polydisperse solutions, DLS was able to resolve two species in a manner dependent on both concentration and particle size. RMM was able to resolve particles above 200 nm (150 nm for protein) at concentrations below 10(9) particles/mL. In addition, dilution was evaluated as a technique to confirm and quantify the number of particles in solution.
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