Evidence map›Paper›PMID 33795759›Full record

ArticleScientific reports2021

Flow virometry for process monitoring of live virus vaccines-lessons learned from ERVEBO.

Geoffri Ricci, Kevin Minsker, Austin Kapish, James Osborn, Sha Ha, Joseph Davide, Joseph P Califano, Darrell Sehlin, Richard R Rustandi, Lawrence W Dick and 5 more

Open access · goldAbstract read
In one paragraph

Article in Scientific reports, 2021. 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
0.8field-weighted citation impact, top 24% 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, 19 citations in OpenAlex.

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  11. MCMV Centrifugal Enhancement: A New Spin on an Old Topic.Pathogens (Basel, Switzerland) · 2021
    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

15 authors at 1 institution in 1 country.

Geoffri RicciVaccines Process Development and Commercialization, Merck & Co., Inc., 770 Sumneytown Pike, WP 42-3, West Point, PA, 19486, USA.
Kevin MinskerVaccines Process Development and Commercialization, Merck & Co., Inc., 770 Sumneytown Pike, WP 42-3, West Point, PA, 19486, USA.
Austin KapishVaccines Process Development and Commercialization, Merck & Co., Inc., 770 Sumneytown Pike, WP 42-3, West Point, PA, 19486, USA.
James OsbornVaccines Process Development and Commercialization, Merck & Co., Inc., 770 Sumneytown Pike, WP 42-3, West Point, PA, 19486, USA.
Sha HaVaccines Process Development and Commercialization, Merck & Co., Inc., 770 Sumneytown Pike, WP 42-3, West Point, PA, 19486, USA.
Joseph DavideVaccines Process Development and Commercialization, Merck & Co., Inc., 770 Sumneytown Pike, WP 42-3, West Point, PA, 19486, USA.
Joseph P CalifanoVaccines Process Development and Commercialization, Merck & Co., Inc., 770 Sumneytown Pike, WP 42-3, West Point, PA, 19486, USA.
Darrell SehlinVaccines Process Development and Commercialization, Merck & Co., Inc., 770 Sumneytown Pike, WP 42-3, West Point, PA, 19486, USA.
Richard R RustandiVaccines Analytical Research and Development, Merck & Co., Inc., West Point, PA, USA.
Lawrence W DickVaccines Analytical Research and Development, Merck & Co., Inc., West Point, PA, USA.
Josef VlasakVaccines Analytical Research and Development, Merck & Co., Inc., West Point, PA, USA.
Timothy D CulpVaccines Process Development, Merck & Co., Inc., West Point, PA, USA.
Andreas BaudySafety Assessment and Laboratory Animal Resources, Merck & Co., Inc., West Point, PA, USA.
Edward BellVaccines Process Development and Commercialization, Merck & Co., Inc., 770 Sumneytown Pike, WP 42-3, West Point, PA, 19486, USA.
Malini MukherjeeVaccines Process Development and Commercialization, Merck & Co., Inc., 770 Sumneytown Pike, WP 42-3, West Point, PA, 19486, USA. malini.mukherjee@merck.com.
United States Military Academy · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Direct at line monitoring of live virus particles in commercial manufacturing of vaccines is challenging due to their small size. Detection of malformed or damaged virions with reduced potency is rate-limited by release potency assays with long turnaround times. Thus, preempting batch failures caused by out of specification potency results is almost impossible. Much needed are in-process tools that can monitor and detect compromised viral particles in live-virus vaccines (LVVs) manufacturing based on changes in their biophysical properties to provide timely measures to rectify process stresses leading to such damage. Using ERVEBO, MSD's Ebola virus vaccine as an example, here we describe a flow virometry assay that can quickly detect damaged virus particles and provide mechanistic insight into process parameters contributing to the damage. Furthermore, we describe a 24-h high throughput infectivity assay that can be used to correlate damaged particles directly to loss in viral infectivity (potency) in-process. Collectively, we provide a set of innovative tools to enable rapid process development, process monitoring, and control strategy implementation in large scale LVV manufacturing.

Indexed as

AnimalsChlorocebus aethiopsEbola VaccinesFlow CytometryHumansTemperatureVaccines, AttenuatedVaccines, SyntheticVaccinologyVero CellsViral VaccinesVirionEbola VaccinesVaccines, AttenuatedVaccines, SyntheticViral Vaccines

Identifiers

PMID33795759
PMCPMC8016999
OpenAlexW3143063046

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.