Evidence map›Paper›PMID 31369743›Full record

ArticleJournal of pharmaceutical sciences2020

Preformulation Characterization and Stability Assessments of Secretory IgA Monoclonal Antibodies as Potential Candidates for Passive Immunization by Oral Administration.

Yue Hu, Ozan S Kumru, Jian Xiong, Lorena R Antunez, John Hickey, Yang Wang, Lisa Cavacini, Mark Klempner, Sangeeta B Joshi, David B Volkin

Open access · hybridAbstract read
In one paragraph

Article in Journal of pharmaceutical sciences, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
3.2field-weighted citation impact, top 9% 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

11 citing papers in PubMed, 23 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Recombinant Human Secretory IgA InducesACS infectious diseases · 2021
    Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. EnterotoxigenicGut microbes
    Review
  11. 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 at 2 institutions in 1 country.

Yue HuDepartment of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center (VAFC), University of Kansas, Lawrence, Kansas 66047.
Ozan S KumruDepartment of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center (VAFC), University of Kansas, Lawrence, Kansas 66047.
Jian XiongDepartment of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center (VAFC), University of Kansas, Lawrence, Kansas 66047.
Lorena R AntunezDepartment of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center (VAFC), University of Kansas, Lawrence, Kansas 66047.
John HickeyDepartment of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center (VAFC), University of Kansas, Lawrence, Kansas 66047.
Yang WangMassBiologics of the University of Massachusetts Medical School, Boston, Massachusetts 02126.
Lisa CavaciniMassBiologics of the University of Massachusetts Medical School, Boston, Massachusetts 02126.
Mark KlempnerMassBiologics of the University of Massachusetts Medical School, Boston, Massachusetts 02126.
Sangeeta B JoshiDepartment of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center (VAFC), University of Kansas, Lawrence, Kansas 66047.
David B VolkinDepartment of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center (VAFC), University of Kansas, Lawrence, Kansas 66047. Electronic address: volkin@ku.edu.
University of Kansas · USUniversity of Massachusetts Chan Medical School · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Enterotoxigenic Escherichia coli (ETEC) is a major cause of diarrheal disease among children in developing countries, and there are no licensed vaccines to protect against ETEC. Passive immunization by oral delivery of ETEC-specific secretory IgAs (sIgAs) could potentially provide an alternative approach for protection in targeted populations. In this study, a series of physiochemical techniques and an in vitro gastric digestion model were used to characterize and compare key structural attributes and stability profiles of 3 anti-heat-labile enterotoxin mAbs (sIgA1, sIgA2, and IgG1 produced in CHO cells). The mAbs were evaluated in terms of primary structure, N-linked glycan profiles, size and aggregate content, relative apparent solubility, conformational stability, and in vitro antigen binding. Compared to IgG1 mAb, sIgA1 and sIgA2 mAbs showed increased sample heterogeneity, especially in terms of N-glycan composition and the presence of higher molecular weight species. The sIgA mAbs showed overall better physical stability and were more resistant to loss of antigen binding activity during incubation at low pH, 37°C with pepsin. These results are discussed in terms of future challenges to design stable, low-cost formulations of sIgA mAbs as an oral supplement for passive immunization to protect against enteric diseases in the developing world.

Indexed as

Immunization, PassiveAdministration, OralAnimalsAntibodies, MonoclonalCHO CellsCricetulusDiarrheaDrug CompoundingDrug StabilityEnterotoxigenic Escherichia coliEscherichia coli InfectionsEscherichia coli ProteinsEscherichia coli VaccinesImmunoglobulin A, SecretoryImmunoglobulin GAntibodies, MonoclonalEscherichia coli ProteinsEscherichia coli VaccinesImmunoglobulin A, SecretoryImmunoglobulin Genterotoxigenic Escherichia coliformulationimmunizationimmunoglobulin Goral deliveryphysicochemical characterizationsecretory immunoglobulin Astability

Identifiers

PMID31369743
PMCPMC6941217
OpenAlexW2964684866

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.