Evidence map›Paper›PMID 34668998›Full record

ReviewAnalytical and bioanalytical chemistry2022

The role of Raman spectroscopy in biopharmaceuticals from development to manufacturing.

Karen A Esmonde-White, Maryann Cuellar, Ian R Lewis

Abstract readReview
In one paragraph

Review in Analytical and bioanalytical chemistry, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 51 papers.

0numbers the graph read from it
0cells of the map it votes in
51citing 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

51 citing papers in PubMed.

  1. Article
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  9. Spectroscopy-Based Cell Culture Predictive Monitoring.Biotech (Basel (Switzerland)) · 2026
    Article
  10. Article
  11. Review
  12. Review
  13. Article
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  16. Review
  17. Raman imaging of molecular groups in the wavenumber silent region.Analytical and bioanalytical chemistry · 2026
    Review
  18. Article
  19. Article
  20. 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

3 authors.

Karen A Esmonde-WhiteEndress+Hauser, 371 Parkland Plaza, MI, 48103, Ann Arbor, USA. karen.esmonde-white@endress.com.
Maryann CuellarEndress+Hauser, 371 Parkland Plaza, MI, 48103, Ann Arbor, USA.
Ian R LewisEndress+Hauser, 371 Parkland Plaza, MI, 48103, Ann Arbor, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Biopharmaceuticals have revolutionized the field of medicine in the types of active ingredient molecules and treatable indications. Adoption of Quality by Design and Process Analytical Technology (PAT) frameworks has helped the biopharmaceutical field to realize consistent product quality, process intensification, and real-time control. As part of the PAT strategy, Raman spectroscopy offers many benefits and is used successfully in bioprocessing from single-cell analysis to cGMP process control. Since first introduced in 2011 for industrial bioprocessing applications, Raman has become a first-choice PAT for monitoring and controlling upstream bioprocesses because it facilitates advanced process control and enables consistent process quality. This paper will discuss new frontiers in extending these successes in upstream from scale-down to commercial manufacturing. New reports concerning the use of Raman spectroscopy in the basic science of single cells and downstream process monitoring illustrate industrial recognition of Raman's value throughout a biopharmaceutical product's lifecycle. Finally, we draw upon a nearly 90-year history in biological Raman spectroscopy to provide the basis for laboratory and in-line measurements of protein quality, including higher-order structure and composition modifications, to support formulation development.

Indexed as

Biological ProductsQuality ControlSpectroscopy, Near-InfraredSpectrum Analysis, RamanTechnology, PharmaceuticalBiological ProductsBiopharmaceuticalCell cultureDownstream bioprocessingProtein higher-order structureRaman spectroscopyUpstream bioprocessing

Identifiers

PMID34668998
PMCPMC8724084

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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.