Innovative approach to support therapeutic proteins' similarity in hydrodynamic size using high-throughput dynamic light scattering and forced degradation.

Ashwinkumar Bhirde, Siri Harish, Nicholas Trunfio, Isabella F de Luna, William Smith, Qiong Fu

Abstract read

In one paragraph

Article in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it

0cells of the map it votes in

0citing papers in PubMed

–field-weighted citation impact

1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Ashwinkumar BhirdeDivision of Product Quality Research VI, Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. ashwinkumar.bhirde@fda.hhs.gov.

Siri HarishDivision of Product Quality Research VI, Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.

Nicholas TrunfioDivision of Product Quality Research VI, Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.

Isabella F de LunaDivision of Product Quality Research VI, Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.

William SmithDivision of Product Quality Research V, Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.

Qiong FuDivision of Product Quality Assessment XIV, Office of Pharmaceutical Quality Assessment III, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Comparative analytical assessment (CAA) between the reference product and the proposed product forms the basis of the biosimilarity demonstration. Though Dynamic Light Scattering (DLS) has been implemented for CAA, its capability beyond signature peak for similarity assessments has remained unexplored. Herein, we have developed a innovative forced degradation based sweet spot method consisting of signature peak, temperature range, increment and hold time using high throughput-DLS (HT-DLS) to show similarity in hydrodynamic size between products. In our study, we used rituximab, its biosimilars, and insulin analogs as model products to demonstrate product similarity in hydrodynamic size (D

Indexed as

Dynamic Light ScatteringHigh-Throughput Screening AssaysRituximabAlgorithmsHumansHydrodynamicsInsulinParticle SizeTemperatureInsulinRituximabBiosimilarsCumulantsDynamic light scatteringHydrodynamic sizeInsulinMonoclonal antibodyPrincipal component analysisProtein aggregationRegularization

Identifiers

PMID41274997

DOI10.1038/s41598-025-97377-6

PMCPMC12644871

What OpenQuestion holds

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Registered trials

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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.