Evidence map›Paper›PMID 41136828›Full record

ReviewAdvances in experimental medicine and biology2025

The Developing Standards Landscape for Cell and Gene Therapies.

Jonathan J Campbell, Julian H Braybrook

Abstract readReview
PubMed Publisher
In one paragraph

Review in Advances in experimental medicine and biology, 2025. 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
–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

0 citing papers in PubMed.

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

2 authors.

Jonathan J CampbellMetBio Scientific Consulting, Market Deeping, UK. jonathan.campbell@metbio.co.uk.
Julian H BraybrookNational Measurement Laboratory, LGC, Teddington, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Effective standardization strategies are critical to the successful development and adoption of complex technological solutions, in many cases due to meeting requirements of interdisciplinary expertise, interconnected systems, or the production of comparable products at scale. Cell and gene therapies, as a new generation of living drugs are a prime example of such a technology, yet with the pace of advance, the challenge to develop appropriate solutions is an increasingly complex and resource-intensive activity, requiring careful prioritization and management. This chapter introduces and develops various drivers for standardization in this sector, the stakeholders involved in this work, and governance structures required for standards development and deployment, helping to overcome challenges associated with product and process characterization, consistent manufacture and regulatory approval.

Indexed as

Cell- and Tissue-Based TherapyGenetic TherapyHumansCharacterizationCritical process parametersCritical quality attributesDocumentary standardsHarmonizationMetrologyQualityReference materialsReference methodsStandardization

Identifiers

PMID41136828

What OpenQuestion holds

Textmetadata
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.