Evidence map›Paper›PMID 37478506›Full record

ArticleBiologicals : journal of the International Association of Biological Standardization2023

Report of the third conference on next-generation sequencing for adventitious virus detection in biologics for humans and animals.

Arifa S Khan, Laurent Mallet, Johannes Blümel, Jean-Pol Cassart, Ivana Knezevic, Siemon H S Ng, Michael Wall, Miia Jakava-Viljanen, Carine Logvinoff, Ana Goios and 1 more

Open access · hybridAbstract read
In one paragraph

Article in Biologicals : journal of the International Association of Biological Standardization, 2023. 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
2.3field-weighted citation impact, top 13% 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, 12 citations in OpenAlex.

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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 8 institutions in 7 countries.

Arifa S KhanDivision of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA. Electronic address: arifa.khan@fda.hhs.gov.
Laurent MalletEuropean Directorate for the Quality of Medicines and Healthcare, Strasbourg, France.
Johannes BlümelPaul-Ehrlich-Institut, Langen, Germany.
Jean-Pol CassartGlobal Quality Control and Product Quality, GSK, Wavre, Belgium.
Ivana KnezevicDepartment of Health Product Policy and Standards, World Health Organization, Geneva, Switzerland.
Siemon H S NgNotch Therapeutics, Vancouver, British Columbia, Canada.
Michael WallHealth Canada, Ottawa, Ontario, Canada.
Miia Jakava-ViljanenFinnish Food Authority, Helsinki, Finland.
Carine LogvinoffSanofi Pasteur, Marcy L'Etoile, France.
Ana GoiosP95 Epidemiology and Pharmacovigilance, Leuven, Belgium.
Pieter NeelsInternational Alliance for Biological Standardization, Geneva, Switzerland.
Center for Biologics Evaluation and Research · USFinnish Food Authority · FIGlaxoSmithKline (Belgium) · BEHealth Canada · CAInternational Alliance for Biological Standardization · CHPaul Ehrlich Institut · DESanofi (France) · FRWorld Health Organization · CH

Funding

World Health Organization 001
6 · The paper itself

Abstract

Next-generation sequencing (NGS) has been proven to address some of the limitations of the current testing methods for adventitious virus detection in biologics. The International Alliance for Biological Standardization (IABS), the U.S. Food and Drug Administration (FDA), and the European Directorate for the Quality of Medicines and Healthcare (EDQM) co-organized the "3rd Conference on Next-generation Sequencing for Adventitious Virus Detection in Biologics for Humans and Animals", which was held on September 27-28, 2022, in Rockville, Maryland, U.S.A. The meeting gathered international representatives from regulatory and public health authorities and other government agencies, industry, contract research organizations, and academia to present the current status of NGS applications and the progress on NGS standardization and validation for detection of viral adventitious agents in biologics, including human and animal vaccines, gene therapies, and biotherapeutics. Current regulatory expectations were discussed for developing a scientific consensus regarding using NGS for detection of adventitious viruses. Although there are ongoing improvements in the NGS workflow, the development of reference materials for facilitating method qualification and validation support the current use of NGS for adventitious virus detection.

Indexed as

Biological ProductsVirusesAnimalsDrug ContaminationHigh-Throughput Nucleotide SequencingHumansMarylandBiological ProductsAdventitious virusesBioinformaticsBiologicsCell substratesHigh-throughput sequencingNext-generation sequencingVaccines

Identifiers

PMID37478506
PMCPMC10522920
OpenAlexW4385064422

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.