Evidence map›Paper›PMID 34725374›Full record

ReviewNPJ Regenerative medicine2021

Induced pluripotency in the context of stem cell expansion bioprocess development, optimization, and manufacturing: a roadmap to the clinic.

James Colter, Kartikeya Murari, Jeff Biernaskie, Michael Scott Kallos

Abstract readReview
In one paragraph

Review in NPJ Regenerative medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–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

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  16. Tumorigenicity risk of iPSCsPrecision clinical medicine · 2022
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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

4 authors.

James ColterPharmaceutical Production Research Facility, University of Calgary, 2500 University Drive NW, Calgary, AB, T2N 1N4, Canada.ORCID http://orcid.org/0000-0001-6612-6931
Kartikeya MurariIntegrated Circuits and Optical Imaging Laboratory, University of Calgary, 2500 University Drive NW, Calgary, AB, T2N 1N4, Canada.
Jeff BiernaskieDepartment of Comparative Biology and Experimental Medicine, Faculty of Veterinary Medicine, University of Calgary, 2500 University Drive NW, Calgary, AB, T2N 1N4, Canada.
Michael Scott KallosPharmaceutical Production Research Facility, University of Calgary, 2500 University Drive NW, Calgary, AB, T2N 1N4, Canada. mskallos@ucalgary.ca.ORCID http://orcid.org/0000-0002-1480-8022

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The translation of laboratory-scale bioprocess protocols and technologies to industrial scales and the application of human induced pluripotent stem cell (hiPSC) derivatives in clinical trials globally presents optimism for the future of stem-cell products to impact healthcare. However, while many promising therapeutic approaches are being tested in pre-clinical studies, hiPSC-derived products currently account for a small fraction of active clinical trials. The complexity and volatility of hiPSCs present several bioprocessing challenges, where the goal is to generate a sufficiently large, high-quality, homogeneous population for downstream differentiation-the derivatives of which must retain functional efficacy and meet regulatory safety criteria in application. It is argued herein that one of the major challenges currently faced in improving the robustness of routine stem-cell biomanufacturing is in utilizing continuous, meaningful assessments of molecular and cellular characteristics from process to application. This includes integrating process data with biological characteristic and functional assessment data to model the interplay between variables in the search for global optimization strategies. Coupling complete datasets with relevant computational methods will contribute significantly to model development and automation in achieving process robustness. This overarching approach is thus crucially important in realizing the potential of hiPSC biomanufacturing for transformation of regenerative medicine and the healthcare industry.

Identifiers

PMID34725374
PMCPMC8560749

What Socratic 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 Socratic graph.