Evidence map›Paper›PMID 41136841›Full record

ReviewAdvances in experimental medicine and biology2025

GMP Manufacturing of Allogenic iPSC-NK Cells for Immunotherapy.

Hongliang Zong, Richard Wang

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. 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. NK cells in HPV-related tumorigenesis: mechanisms and clinical applications.Frontiers in cellular and infection microbiology · 2025
    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

2 authors.

Hongliang ZongNeukio Biotherapeutics, Floor 3, Building 7-5, 215 South Fute Road, China (Shanghai) Pilot Free Trade Zone, Shanghai, China.
Richard WangNeukio Biotherapeutics, Floor 3, Building 7-5, 215 South Fute Road, China (Shanghai) Pilot Free Trade Zone, Shanghai, China. richard.wang@neukio.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Human induced pluripotent stem cell (iPSC)-derived natural killer (NK) cells are the most suitable immune cell therapy types for allogeneic application, due to the TCR-independent innate immune activity of NKs devoid of GvHD side effects. In addition, the amenability of genetic engineering and the potential of scalable manufacturing of homogenic iNK from an established bank of iPSC clones make it an excellent starting material for cell therapies. However, as there is no approved iNK therapeutic product on the market yet, the extent of robustness and regulatory compliance of good manufacturing practice (GMP) is not established and proven, nor is it straightforward. We will review the current development and validation status of iPSC-NK manufacturing processes, along with quality controls, based on literature information and our own experience, towards the goal of manufacturing large-scale iNK products for regulatory submission and future commercialization.

Indexed as

ImmunotherapyInduced Pluripotent Stem CellsKiller Cells, NaturalCell DifferentiationHumansQuality Control3-tier BankingAllogenic TherapyCritical Process Parameters (CPP)Critical Quality Attributes (CQA)CryopreservationFeeder-free Suspension CultureGMP complianceInduced Pluripotent Stem Cell (iPSC)iNK CharacterizationNatural Killers (NK) CellNK ActivationRelease TestingScale-up Manufacturing

Identifiers

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.