Evidence map›Paper›PMID 33897983›Full record

ArticleComputational and structural biotechnology journal2021

In-line monitoring of surfactant clearance in viral vaccine downstream processing.

Jessie Payne, James Cronin, Manjit Haer, Jason Krouse, William Prosperi, Katherine Drolet-Vives, Matthew Lieve, Michael Soika, Matthew Balmer, Marina Kirkitadze

Open access · goldAbstract read
In one paragraph

Article in Computational and structural biotechnology journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
1.0field-weighted citation impact, top 17% 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

0 citing papers in PubMed, 6 citations in OpenAlex.

No citing paper in PubMed yet.

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

10 authors at 4 institutions in 2 countries.

Jessie PayneAnalytical Sciences, Sanofi Pasteur, Toronto, Canada.
James CroninMettler Toledo AutoChem Inc., Columbia, USA.
Manjit HaerAnalytical Sciences, Sanofi Pasteur, Toronto, Canada.
Jason KrouseManufacturing Technology, Sanofi Pasteur, Swiftwater, USA.
William ProsperiManufacturing Technology, Sanofi Pasteur, Swiftwater, USA.
Katherine Drolet-VivesMettler Toledo AutoChem Inc., Columbia, USA.
Matthew LieveViral Manufacturing, Industrial Affairs, Sanofi Pasteur, Swiftwater, USA.
Michael SoikaManufacturing Technology, Sanofi Pasteur, Swiftwater, USA.
Matthew BalmerAnalytical Sciences, Sanofi Pasteur, Toronto, Canada.
Marina KirkitadzeAnalytical Sciences, Sanofi Pasteur, Toronto, Canada.
Sanofi (United States) · USSanofi (Canada) · CAMettler-Toledo (United States) · USQueen's University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe goal of this study is to examine the suitability of in-line infrared measurements to monitor, in real-time, surfactant concentration in the viral vaccine drug substance during a 50KDa tangential flow filtration (TFF) process.

methodsA ReactIR™ 702L instrument was used to gather spectra of process off-line samples and reference materials to assess the feasibility of monitoring surfactant concentration during a TFF process in real-time. Both univariate and multivariate models were used to evaluate the off-line sample data and were found to be in good agreement with surfactant concentration values obtained by HPLC. These results were used as justification for a real-time TFF experiment with live process material.

resultsSmall scale ReactIR experiments with process material demonstrated that a multivariate model using the 1300 cm

conclusionThe results of this study demonstrated suitability of an in-line infrared measurement to monitor surfactant concentration in the viral vaccine drug substance between exchanges 8-15 of a 50 kDa tangential flow filtration process. The preliminary multivariate model used for this work can be further optimized for the in-line use at manufacturing scale.

Indexed as

ClearanceIRPATReactIRResidualsViral vaccine

Identifiers

PMID33897983
PMCPMC8056174
OpenAlexW3151883212

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.