Evidence map›Paper›PMID 36949219›Full record

ArticleAAPS PharmSciTech2023

Evaluation and Screening of Biopharmaceuticals using Multi-Angle Dynamic Light Scattering.

Ashutosh Sharma, Jason Beirne, Dikshitkumar Khamar, Ciaran Maguire, Ambrose Hayden, Helen Hughes

Open access · bronzeAbstract read
In one paragraph

Article in AAPS PharmSciTech, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.3field-weighted citation impact, top 12% of its field
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

4 citing papers in PubMed, 15 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Article
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 at 2 institutions in 1 country.

Ashutosh SharmaPharmaceutical and Molecular Biotechnology Research Centre (PMBRC), South East Technological University (SETU), Main Campus, Cork Road, Waterford, X91 K0EK, Ireland. ashutosh.sharma@postgrad.wit.ie.ORCID http://orcid.org/0000-0002-5054-8432
Jason BeirneManufacturing Science, Analytics and Technology (MSAT), Sanofi, IDA Industrial Park, Waterford, X91 TP27, Ireland.
Dikshitkumar KhamarManufacturing Science, Analytics and Technology (MSAT), Sanofi, IDA Industrial Park, Waterford, X91 TP27, Ireland.
Ciaran MaguireParticular Sciences Ltd, Rosemount Business Park, Ballycoolin, D11 T327, Dublin, Ireland.
Ambrose HaydenPharmaceutical and Molecular Biotechnology Research Centre (PMBRC), South East Technological University (SETU), Main Campus, Cork Road, Waterford, X91 K0EK, Ireland.
Helen HughesPharmaceutical and Molecular Biotechnology Research Centre (PMBRC), South East Technological University (SETU), Main Campus, Cork Road, Waterford, X91 K0EK, Ireland. helen.hughes@setu.ie.
Munster Technological University · IEWaterford Institute of Technology · IE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Biopharmaceuticals are large, complex and labile therapeutic molecules prone to instability due to various factors during manufacturing. To ensure their safety, quality and efficacy, a wide range of critical quality attributes (CQAs) such as product concentration, aggregation, particle size, purity and turbidity have to be met. Size exclusion chromatography (SEC) is the gold standard to measure protein aggregation and degradation. However, other techniques such as dynamic light scattering (DLS) are employed in tandem to measure the particle size distribution (PSD) and polydispersity of biopharmaceutical formulations. In this study, the application of multi-angle dynamic light scattering (MADLS) was evaluated for the determination of particle size, particle concentration and aggregation in 3 different protein modalities, namely bovine serum albumin (BSA) and two biopharmaceuticals including a monoclonal antibody (mAb) and an enzyme. The obtained calibration curve (R

Indexed as

Biological ProductsAntibodies, MonoclonalDynamic Light ScatteringLightSerum Albumin, BovineAntibodies, MonoclonalBiological ProductsSerum Albumin, Bovinebiopharmaceutical characterizationbiopharmaceuticalsdynamic light scatteringsize exclusion chromatographyspectroscopy

Identifiers

PMID36949219
PMCPMC10033178
OpenAlexW4353029639

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.