Evidence map›Paper›PMID 34986360›Full record

ReviewJournal of pharmaceutical sciences2022

Best Practices for Aggregate Quantitation of Antibody Therapeutics by Sedimentation Velocity Analytical Ultracentrifugation.

George M Bou-Assaf, Ivan L Budyak, Michael Brenowitz, Eric S Day, David Hayes, John Hill, Ranajoy Majumdar, Paola Ringhieri, Peter Schuck, Jasper C Lin

Abstract readReview
In one paragraph

Review in Journal of pharmaceutical sciences, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing 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

16 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. An automated interface for sedimentation velocity analysis in SEDFIT.bioRxiv : the preprint server for biology · 2023
    Article
  15. Article
  16. 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

10 authors.

George M Bou-AssafAnalytical Development, Biogen, 225 Binney St., Cambridge, MA 02142.
Ivan L BudyakBioproduct Research and Development, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA.
Michael BrenowitzDepartments of Biochemistry and Molecular Pharmacology, Albert Einstein College of Medicine, 1300 Morris Park Avenue, Bronx, NY 10461.
Eric S DayPharmaceutical Development, Genentech a Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080.
David HayesIntlSoSci, 23 Washington St., Gorham, NH 03581.
John HillDepartment of Bioengineering, University of Washington, Seattle, WA 98105.
Ranajoy MajumdarBioproduct Research and Development, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA.
Paola RinghieriAnalytical Development Biotech Department, Merck Serono S.p.a, Guidonia, RM, Italy; an affiliate of Merck KGaA.
Peter SchuckLaboratory of Dynamics of Macromolecular Assembly, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, 13 South Drive, Bethesda, MD 20892.
Jasper C LinPharmaceutical Development, Genentech a Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080. Electronic address: lin.jasper@gene.com.

Funding

Higher-Order Structure and Solution Interactions of AntibodiesZIAEB000092 · NIBIB · NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING · PI SCHUCK, PETER · 2019 to 2021
$318k
Intramural NIH HHS ZIA EB000092
6 · The paper itself

Abstract

Analytical ultracentrifugation (AUC) is a critical analytical tool supporting the development and manufacture of protein therapeutics. AUC is routinely used as an assay orthogonal to size exclusion chromatography for aggregate quantitation. This article distills the experimental and analysis procedures used by the authors for sedimentation velocity AUC into a series of best-practices considerations. The goal of this distillation is to help harmonize aggregate quantitation approaches across the biopharmaceutical industry. We review key considerations for sample and instrument suitability, experimental design, and data analysis best practices and conversely, highlight potential pitfalls to accurate aggregate analysis. Our goal is to provide experienced users benchmarks against which they can standardize their analyses and to provide guidance for new AUC analysts that will aid them to become proficient in this fundamental technique.

Indexed as

Antibodies, MonoclonalChromatography, GelUltracentrifugationAntibodies, MonoclonalAnalytical ultracentrifugationAntibody drug(s)Antibody(s)Biopharmaceutical characterizationHPLC (high performance/pressure liquid chromatographyMonoclonal antibody(s)Protein aggregation

Identifiers

PMID34986360
PMCPMC9232890

What OpenQuestion holds

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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.