Evidence map›Paper›PMID 36298454›Full record

ArticleVaccines2022

Rapid In-Process Measurement of Live Virus Vaccine Potency Using Laser Force Cytology: Paving the Way for Rapid Vaccine Development.

Reilly McCracken, Noor Al-Nazal, Travis Whitmer, Sijia Yi, James M Wagner, Colin G Hebert, Matthew J Lowry, Peter R Hayes, James W Schneider, Todd M Przybycien and 1 more

Open access · goldAbstract read
In one paragraph

Article in Vaccines, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.7field-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

5 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Arsenic-induced prostate cancer: an enigma.Medical oncology (Northwood, London, England) · 2024
    Review
  5. Review
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

11 authors at 3 institutions in 1 country.

Reilly McCrackenGlobal Vaccines and Biologics Commercialization, Merck & Co., Inc., West Point, PA 19486, USA.
Noor Al-NazalGlobal Vaccines and Biologics Commercialization, Merck & Co., Inc., West Point, PA 19486, USA.
Travis WhitmerGlobal Vaccines and Biologics Commercialization, Merck & Co., Inc., West Point, PA 19486, USA.ORCID 0000-0001-9321-0637
Sijia YiGlobal Vaccines and Biologics Commercialization, Merck & Co., Inc., West Point, PA 19486, USA.
James M WagnerVaccines Process Development, Merck & Co., Inc., West Point, PA 19486, USA.
Colin G HebertLumaCyte, Inc., 1145 River Road, Suite 16, Charlottesville, VA 22901, USA.
Matthew J LowryLumaCyte, Inc., 1145 River Road, Suite 16, Charlottesville, VA 22901, USA.
Peter R HayesDepartment of Chemical Engineering, Carnegie Mellon University, Pittsburgh, PA 15213, USA.ORCID 0000-0002-6142-0848
James W SchneiderDepartment of Chemical Engineering, Carnegie Mellon University, Pittsburgh, PA 15213, USA.
Todd M PrzybycienDepartment of Chemical and Biological Engineering, Rensselaer Polytechnic Institute, Troy, NY 12180, USA.
Malini MukherjeeAnalytical Research & Development, Merck & Co., Inc., West Point, PA 19486, USA.
United States Military Academy · USCarnegie Mellon University · USRensselaer Polytechnic Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Vaccinations to prevent infectious diseases are given to target the body's innate and adaptive immune systems. In most cases, the potency of a live virus vaccine (LVV) is the most critical measurement of efficacy, though in some cases the quantity of surface antigen on the virus is an equally critical quality attribute. Existing methods to measure the potency of viruses include plaque and TCID50 assays, both of which have very long lead times and cannot provide real time information on the quality of the vaccine during large-scale manufacturing. Here, we report the evaluation of LumaCyte's Radiance Laser Force Cytology platform as a new way to measure the potency of LVVs in upstream biomanufacturing process in real time and compare this to traditional TCID50 potency. We also assess this new platform as a way to detect adventitious agents, which is a regulatory expectation for the release of commercial vaccines. In both applications, we report the ability to obtain expedited and relevant potency information with strong correlation to release potency methods. Together, our data propose the application of Laser Force Cytology as a valuable process analytical technology (PAT) for the timely measurement of critical quality attributes of LVVs.

Indexed as

laser force cytologylive virus vaccinesmanufacturingmicrocarriersviral potency

Identifiers

PMID36298454
PMCPMC9608199
OpenAlexW4296999088

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.