Evidence map›Paper›PMID 32094072›Full record

ArticleBiologicals : journal of the International Association of Biological Standardization2020

Report of the 2019 NIST-FDA workshop on standards for next generation sequencing detection of viral adventitious agents in biologics and biomanufacturing.

Megan H Cleveland, Bharathi Anekella, Michael Brewer, Pei-Ju Chin, Heather Couch, Eric Delwart, Jim Huggett, Scott Jackson, Javier Martin, Serge Monpoeho and 4 more

Open access · greenAbstract readConference Proceedings
PubMed Full text at PMC Publisher
In one paragraph

Article in Biologicals : journal of the International Association of Biological Standardization, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.0field-weighted citation impact, top 14% 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

3 citing papers in PubMed, 15 citations in OpenAlex.

  1. Review
  2. Review
  3. 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

14 authors at 10 institutions in 3 countries.

Megan H ClevelandNational Institute of Standards and Technology, 100 Bureau Dr, Gaithersburg, MD, 20899, USA.
Bharathi AnekellaLGC-Clinical Diagnostic Business Unit, 910 Clopper Road, Gaithersburg, MD, 20878, USA.
Michael BrewerThermo Fisher Scientific, 35 Wiggins Ave, Bedford, MA, 01730, USA.
Pei-Ju ChinCenter for Biologics Research and Evaluation, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
Heather CouchAmerican Type Culture Collection, 10801 University Boulevard, Manassas, VA, 20110, USA.
Eric DelwartVitalant Research Institute, 270 Masonic Ave, San Francisco, CA, 94118, USA.
Jim HuggettNational Measurement Laboratory at LGC, Queens Road, Teddington, TW11 0LY, UK; School of Biosciences & Medicine, Faculty of Health & Medical Sciences, University of Surrey, Guildford, Surrey, GU2 7XH, UK.
Scott JacksonNational Institute of Standards and Technology, 100 Bureau Dr, Gaithersburg, MD, 20899, USA.
Javier MartinNational Institute for Biological Standards and Control, Blanche Ln, South Mimms, Potters Bar, EN6 3QG, UK.
Serge MonpoehoRegeneron Pharmaceuticals, 81 Columbia Turnpike, Rensselaer, NY, 12144, USA.
Tom MorrisonAccuGenomics, 1410 Commonwealth Dr. Ste. 105, Wilmington, NC, 28403, USA.
Siemon H S NgAnalytical Sciences, Sanofi Pasteur, Analytical Research and Development, 1755, Steeles Avenue West, M2R 3T4, Toronto, Ontario, Canada.
David UsseryDepartment of Biomedical Informatics, University of Arkansas for Medical Sciences, Little Rock, AR, 72205, USA.
Arifa S KhanCenter for Biologics Research and Evaluation, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA. Electronic address: arifa.khan@fda.hhs.gov.
National Institute of Standards and Technology · USUnited States Food and Drug Administration · USAmerican Type Culture Collection · USNational Institute for Biological Standards and Control · GBPacific Research Institute · USRegeneron (United States) · USSanofi (Canada) · CAThermo Fisher Scientific (United States) · USUniversity of Arkansas for Medical Sciences · USUniversity of Surrey · GB

Funding

Intramural NIST DOC 9999-NIST
6 · The paper itself

Abstract

Adventitious virus testing assures product safety by demonstrating the absence of viruses that could be unintentionally introduced during the manufacturing process. The capabilities of next-generation sequencing (NGS) for broad virus detection in biologics have been demonstrated by the detection of known and novel viruses that were previously missed using the recommended routine assays for adventitious agent testing. A meeting was co-organized by the National Institute of Standards and Technology and the U.S. Food and Drug Administration on September 18-19, 2019 in Gaithersburg, Maryland, USA, to facilitate standardization of NGS technologies for applications of adventitious virus testing in biologics. The goal was to assess the currently used standards for virus detection by NGS and their public availability, and to identify additional needs for different types of reference materials and standards (natural and synthetic). The meeting focused on the NGS processes from sample preparation through sequencing but did not thoroughly cover bioinformatics, since this was considered to be the topic of a separate meeting.

Indexed as

Drug ContaminationBiological ProductsCongresses as TopicDNA, ViralEducationHigh-Throughput Nucleotide SequencingHumansUnited StatesVirusesBiological ProductsDNA, ViralAdventitious virusesAlternative methodsAssay standardizationAssay validationBioinformaticsBiologicsHigh-throughput sequencingNext generation sequencingReference materialsStandardsVaccinesVirus detection

Identifiers

PMID32094072
PMCPMC9987593
OpenAlexW3008781252

What OpenQuestion holds

Textmetadata
LicenceTDM
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.