Evidence map›Paper›PMID 32341561›Full record

ReviewNature biotechnology2020

Viral contamination in biologic manufacture and implications for emerging therapies.

Paul W Barone, Michael E Wiebe, James C Leung, Islam T M Hussein, Flora J Keumurian, James Bouressa, Audrey Brussel, Dayue Chen, Ming Chong, Houman Dehghani and 24 more

Abstract readReview
PubMed Publisher
In one paragraph

Review in Nature biotechnology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 80 papers.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed
–field-weighted citation impact
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

80 citing papers in PubMed.

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20 more citing papers are in PubMed but not listed here.

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

34 authors.

Paul W BaroneCenter for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA, USA.
Michael E WiebeCenter for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA, USA.
James C LeungCenter for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA, USA.
Islam T M HusseinCenter for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA, USA.
Flora J KeumurianCenter for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA, USA.
James BouressaPfizer Inc., Andover, MA, USA.
Audrey BrusselSanofi, Paris, France.
Dayue ChenEli Lilly, Indianapolis, IN, USA.
Ming ChongCSL Behring, Melbourne, Victoria, Australia.
Houman DehghaniAmgen, Thousand Oaks, CA, USA.
Lionel GerentesSanofi Pasteur, Marcy L'Étoile, France.
James GilbertBiogen Inc., Cambridge, MA, USA.
Dan GoldBioMarin, San Raphael, CA, USA.
Robert KissGenentech, South San Francisco, CA, USA.
Thomas R KreilBaxter/Baxalta/Shire, now part of Takeda, Vienna, Austria.
René LabatutSanofi, Paris, France.
Yuling LiMedImmune, Gaithersburg, MD, USA.
Jürgen MüllbergBristol-Myers Squibb, Devens, MA, USA.
Laurent MalletSanofi Pasteur, Marcy L'Étoile, France.
Christian MenzelMerck Group, Geneva, Switzerland.
Mark MoodyMerrimack Pharmaceuticals, Cambridge, MA, USA.
Serge MonpoehoRegeneron, Rensselaer, NY, USA.
Marie MurphyEli Lilly, Indianapolis, IN, USA.
Mark PlavsicSanofi Genzyme, Cambridge, MA, USA.
Nathan J RothCSL Behring, Bern, Switzerland.
David RoushMerck & Co., Inc., Kenilworth, NJ, USA.
Michael RuffingBoehringer Ingelheim, Biberach, Germany.
Richard SchichoBristol-Myers Squibb, New York, NY, USA.
Richard SnyderBrammer Bio, Alachua, FL, USA.
Daniel StarkNovartis, Basel, Switzerland.
Chun ZhangShire, Lexington, MA, USA.
Jacqueline WolfrumCenter for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA, USA.
Anthony J SinskeyCenter for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA, USA.
Stacy L SpringsCenter for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA, USA. ssprings@mit.edu.ORCID http://orcid.org/0000-0003-2133-5689

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Recombinant protein therapeutics, vaccines, and plasma products have a long record of safety. However, the use of cell culture to produce recombinant proteins is still susceptible to contamination with viruses. These contaminations cost millions of dollars to recover from, can lead to patients not receiving therapies, and are very rare, which makes learning from past events difficult. A consortium of biotech companies, together with the Massachusetts Institute of Technology, has convened to collect data on these events. This industry-wide study provides insights into the most common viral contaminants, the source of those contaminants, the cell lines affected, corrective actions, as well as the impact of such events. These results have implications for the safe and effective production of not just current products, but also emerging cell and gene therapies which have shown much therapeutic promise.

Indexed as

Biological ProductsCell Culture TechniquesData CollectionDrug ContaminationDrug IndustryHumansInformation DisseminationMassachusettsVirusesBiological Products

Identifiers

PMID32341561

What OpenQuestion holds

Textmetadata
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.