Evidence map›Paper›PMID 36514527›Full record

ArticleEngineering in life sciences2022

Applying intensified design of experiments to mammalian cell culture processes.

Verena Nold, Lisa Junghans, Lorenzo Bisgen, Raphael Drerup, Beate Presser, Ingo Gorr, Thomas Schwab, Bettina Knapp, Stefan Wieschalka

Open access · goldAbstract read
In one paragraph

Article in Engineering in life sciences, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.5field-weighted citation impact, top 37% 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

7 citing papers in PubMed, 11 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

9 authors at 2 institutions in 3 countries.

Verena NoldDevelopment Biologicals Boehringer Ingelheim Pharma GmbH & Co KG Biberach an der Riß Germany.ORCID https://orcid.org/0000-0003-0302-0966
Lisa JunghansDevelopment Biologicals Boehringer Ingelheim Pharma GmbH & Co KG Biberach an der Riß Germany.
Lorenzo BisgenUniversity of Ulm Ulm Germany.
Raphael DrerupDevelopment Biologicals Boehringer Ingelheim Pharma GmbH & Co KG Biberach an der Riß Germany.
Beate PresserDevelopment Biologicals Boehringer Ingelheim Pharma GmbH & Co KG Biberach an der Riß Germany.
Ingo GorrDevelopment Biologicals Boehringer Ingelheim Pharma GmbH & Co KG Biberach an der Riß Germany.
Thomas SchwabDevelopment Biologicals Boehringer Ingelheim Pharma GmbH & Co KG Biberach an der Riß Germany.
Bettina KnappDevelopment Biologicals Boehringer Ingelheim Pharma GmbH & Co KG Biberach an der Riß Germany.
Stefan WieschalkaDevelopment Biologicals Boehringer Ingelheim Pharma GmbH & Co KG Biberach an der Riß Germany.
Boehringer Ingelheim (Germany) · DEUniversität Ulm · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The analysis of data collected using design of experiments (DoE) is the current gold standard to determine the influence of input parameters and their interactions on process performance and product quality. In early development, knowledge on the bioprocess of a new product is limited. Many input parameters need to be investigated for a thorough investigation. For eukaryotic cell cultures, intensified DoE (iDoE) has been proposed as efficient tool, requiring fewer bioreactor runs by introducing setpoint changes during the bioprocess. We report the first successful application of iDoE to mammalian cell culture, performing sequential setpoint changes in the growth phase for the selected input parameters temperature and dissolved oxygen. The process performance data were analyzed using ordinary least squares regression. Our results indicate iDoE to be applicable to mammalian bioprocesses and to be a cost-efficient option to inform modeling early on during process development. Even though only half the number of bioreactor runs were used in comparison to a classical DoE approach, the resulting models revealed comparable input-output relations. Being able to examine several setpoint levels within one bioreactor run, we confirm iDoE to be a promising tool to speed up biopharmaceutical process development.

Indexed as

best‐cost strategyearly stage developmentindustrial mammalian cell cultureintensified design of experimentsmodeling upstream bioprocessing

Identifiers

PMID36514527
PMCPMC9731596
OpenAlexW3215496563

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.