Evidence map›Paper›PMID 27020987›Full record

ArticleJournal of pharmaceutical sciences2016

Silicone Oil Microdroplets Can Induce Antibody Responses Against Recombinant Murine Growth Hormone in Mice.

Carly Fleagle Chisholm, Abby E Baker, Kaitlin R Soucie, Raul M Torres, John F Carpenter, Theodore W Randolph

Open access · greenAbstract read
In one paragraph

Article in Journal of pharmaceutical sciences, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.0field-weighted citation impact, top 15% 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

9 citing papers in PubMed, 37 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Article
  6. Closed-system transfer device use with oncology biologics: A survey of Canadian healthcare practitioners.Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners · 2022
    Article
  7. Differences in the incidence of aflibercept-related sterile endophthalmitis according to types of disposable syringes used.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2022
    Article
  8. Review
  9. 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 3 institutions in 1 country.

Carly Fleagle ChisholmDepartment of Chemical and Biological Engineering, University of Colorado, Boulder, Colorado 80309.
Abby E BakerDepartment of Chemical and Biological Engineering, University of Colorado, Boulder, Colorado 80309.
Kaitlin R SoucieDepartment of Chemical and Biological Engineering, University of Colorado, Boulder, Colorado 80309.
Raul M TorresDepartment of Immunology & Microbiology, University of Colorado School of Medicine, Aurora, Colorado 80045.
John F CarpenterDepartment of Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, Colorado 80045.
Theodore W RandolphDepartment of Chemical and Biological Engineering, University of Colorado, Boulder, Colorado 80309. Electronic address: Theodore.randolph@colorado.edu.
University of Colorado Boulder · USUniversity of Colorado Anschutz Medical Campus · USUniversity of Colorado Denver · US

Funding

Biotechnology Research Partnerships Renewal: Aggregation of Therapeutic ProteinsR01EB006006 · NIBIB · UNIVERSITY OF COLORADO · PI RANDOLPH, THEODORE W · 2006 to 2017
$7.2M
Chemokine response in B cell development and functionR01AI052157 · NIAID · UNIVERSITY OF COLORADO DENVER · PI TORRES, RAUL MARTIN · 2002 to 2017
$5.4M
NIAID NIH HHS R01 AI052157NIBIB NIH HHS R01 EB006006
6 · The paper itself

Abstract

Therapeutic protein products can cause adverse immune responses in patients. The presence of subvisible particles is a potential contributing factor to the immunogenicity of parenterally administered therapeutic protein formulations. Silicone oil microdroplets, which derive from silicone oil used as a lubricating coating on barrels of prefilled glass syringes, are often found in formulations. In this study, we investigated the potential of silicone oil microdroplets to act as adjuvants to induce an immune response in mice against a recombinant murine protein. Antibody responses in mice to subcutaneous injections of formulations of recombinant murine growth hormone (rmGH) that contained silicone oil microdroplets were measured and compared to responses to oil-free rmGH formulations. When rmGH formulations containing silicone oil microdroplets were administered once every other week, anti-rmGH antibodies were not detected. In contrast, mice exhibited a small IgG1 response against rmGH when silicone oil-containing rmGH formulations were administered daily, and an anti-rmGH IgM response was observed at later time points. Our findings showed that silicone oil microdroplets can act as an adjuvant to promote a break in immunological tolerance and induce antibody responses against a recombinant self-protein.

Indexed as

MicrospheresAnimalsAntibody FormationFemaleGrowth HormoneInjections, SubcutaneousMiceMice, Inbred BALB CMice, Inbred C57BLParticle SizeSilicone OilsGrowth HormoneSilicone Oilsadjuvant effectimmune responseimmunogenicityparticle sizeprefilled syringesprotein aggregationprotein formulationprotein structuresilicone oilsubvisible particles

Identifiers

PMID27020987
PMCPMC4846524
OpenAlexW2309101429

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.