Evidence map›Paper›PMID 29168076›Full record

ArticlePharmaceutical research2017

Model-Based Methods in the Biopharmaceutical Process Lifecycle.

Paul Kroll, Alexandra Hofer, Sophia Ulonska, Julian Kager, Christoph Herwig

Abstract read
In one paragraph

Article in Pharmaceutical research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing 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

15 citing papers in PubMed.

  1. Article
  2. Article
  3. Lifecycle DoE-The Companion for a Holistic Development Process.Bioengineering (Basel, Switzerland) · 2024
    Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Towards the Development of Digital Twins for the Bio-manufacturing Industry.Advances in biochemical engineering/biotechnology · 2021
    Article
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Article
  15. Wanted: more monitoring and control during inclusion body processing.World journal of microbiology & biotechnology · 2018
    Review
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

5 authors.

Paul KrollResearch Area Biochemical Engineering, Institute of Chemical Environmental and Biological Engineering, Vienna University of Technology, Gumpendorfer Straße 1a - 166/4, A-1060, Vienna, Austria.
Alexandra HoferResearch Area Biochemical Engineering, Institute of Chemical Environmental and Biological Engineering, Vienna University of Technology, Gumpendorfer Straße 1a - 166/4, A-1060, Vienna, Austria.
Sophia UlonskaResearch Area Biochemical Engineering, Institute of Chemical Environmental and Biological Engineering, Vienna University of Technology, Gumpendorfer Straße 1a - 166/4, A-1060, Vienna, Austria.
Julian KagerResearch Area Biochemical Engineering, Institute of Chemical Environmental and Biological Engineering, Vienna University of Technology, Gumpendorfer Straße 1a - 166/4, A-1060, Vienna, Austria.
Christoph HerwigResearch Area Biochemical Engineering, Institute of Chemical Environmental and Biological Engineering, Vienna University of Technology, Gumpendorfer Straße 1a - 166/4, A-1060, Vienna, Austria. christoph.herwig@tuwien.ac.at.ORCID http://orcid.org/0000-0003-2314-1458

Funding

Christian Doppler Forschungsgesellschaft 171Österreichische Forschungsförderungsgesellschaft 843546
6 · The paper itself

Abstract

Model-based methods are increasingly used in all areas of biopharmaceutical process technology. They can be applied in the field of experimental design, process characterization, process design, monitoring and control. Benefits of these methods are lower experimental effort, process transparency, clear rationality behind decisions and increased process robustness. The possibility of applying methods adopted from different scientific domains accelerates this trend further. In addition, model-based methods can help to implement regulatory requirements as suggested by recent Quality by Design and validation initiatives. The aim of this review is to give an overview of the state of the art of model-based methods, their applications, further challenges and possible solutions in the biopharmaceutical process life cycle. Today, despite these advantages, the potential of model-based methods is still not fully exhausted in bioprocess technology. This is due to a lack of (i) acceptance of the users, (ii) user-friendly tools provided by existing methods, (iii) implementation in existing process control systems and (iv) clear workflows to set up specific process models. We propose that model-based methods be applied throughout the lifecycle of a biopharmaceutical process, starting with the set-up of a process model, which is used for monitoring and control of process parameters, and ending with continuous and iterative process improvement via data mining techniques.

Indexed as

BiotechnologyData MiningHumansModels, BiologicalResearch DesignTechnology, PharmaceuticalWorkflowbioprocessdata miningmodellingmonitoringoptimization

Identifiers

PMID29168076
PMCPMC5736780

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.