Evidence map›Paper›PMID 39593749›Full record

ArticleBioengineering (Basel, Switzerland)2024

Lifecycle DoE-The Companion for a Holistic Development Process.

Marco Kunzelmann, Anja Wittmann, Beate Presser, Philipp Brosig, Pia Kristin Marhoffer, Marlene Antje Haider, Julia Martin, Martina Berger, Thomas Wucherpfennig

Abstract read
In one paragraph

Article in Bioengineering (Basel, Switzerland), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

9 authors.

Marco KunzelmannDevelopment Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorferstraße 65, 88397 Biberach an der Riß, Germany.ORCID 0000-0003-3005-5718
Anja WittmannDevelopment Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorferstraße 65, 88397 Biberach an der Riß, Germany.
Beate PresserDevelopment Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorferstraße 65, 88397 Biberach an der Riß, Germany.
Philipp BrosigDevelopment Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorferstraße 65, 88397 Biberach an der Riß, Germany.
Pia Kristin MarhofferDevelopment Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorferstraße 65, 88397 Biberach an der Riß, Germany.
Marlene Antje HaiderDevelopment Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorferstraße 65, 88397 Biberach an der Riß, Germany.
Julia MartinDevelopment Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorferstraße 65, 88397 Biberach an der Riß, Germany.
Martina BergerHP BioP Operations Network Mammalian, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorferstraße 65, 88397 Biberach an der Riß, Germany.
Thomas WucherpfennigDevelopment Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorferstraße 65, 88397 Biberach an der Riß, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Within process development, numerous experimental studies are undertaken to establish, optimize and characterize individual bioprocess unit operations. These studies pursue diverse objectives such as enhancing titer or minimizing impurities. Consequently, Design of Experiment (DoE) studies are planned and analyzed independently from each other, making it challenging to interlink individual data sets to form a comprehensive overview at the conclusion of the development process. This paper elucidates the methodology for constructing a Life-Cycle-DoE (LDoE), which integrates data-driven process knowledge through design augmentations. It delves into the strategy, highlights the challenges encountered and provides solutions for overcoming them. The LDoE approach facilitates the augmentation of an existing model with new experiments in a unified design. It allows for flexible design adaptations as per the requirements of subject matter experts (SME) during process development, concurrently enhancing model predictions by utilizing all available data. The LDoE boasts a broad application spectrum as it consolidates all data generated within bioprocess development into a single file and model. The study demonstrates that the LDoE approach enables a process characterization study (PCS) to be performed solely with development data. Furthermore, it identifies potentially critical process parameters (pCPPs) early, allowing for timely adaptations in process development to address these challenges.

Indexed as

bioprocess developmentCMC developmentdesign augmentationdesign of experimentsholistic experimental designoptimization and robustness analysisprocess characterization studyquality by design

Identifiers

PMID39593749
PMCPMC11591819

What OpenQuestion holds

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Registered trials

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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.