ReviewAnnals of laboratory medicine2024
Manufacturing Cell and Gene Therapies: Challenges in Clinical Translation.
Review in Annals of laboratory medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 2 of them syntheses that pooled 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.
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.
Who cites it
43 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Heating the Cold: Overcoming Immunotherapy Resistance in Microsatellite-Stable Colorectal Cancer: A Systematic Review.Molecules (Basel, Switzerland) · 2026Pooled it
- Outlook of Cell Gene Therapies Development and Approval from Quality and Regulatory Perspective.Therapeutic innovation & regulatory science · 2026Pooled it
- Performance of a modular robotic cluster matches skilled human operators for complex cell therapy manufacturing tasks.International journal of pharmaceutics: X · 2026Article
- Fracture healing: from molecular and cellular mechanisms to therapeutic strategies.Signal transduction and targeted therapy · 2026Review
- Article
- Gene therapy: The current trajectory of clinical and commercial translation.Progress in biophysics and molecular biology · 2026Review
- Predicting ACI Outcomes with GMP In-Process Control Kinetic Metrics: Initial Chondrocyte Yield and Population Doubling Time as Prognostic Clinical Biomarkers.Life (Basel, Switzerland) · 2026Article
- Harnessing immunity against breast cancer: from checkpoints to cell therapies.Journal of translational medicine · 2026Review
- Hydrodynamic dispersion drives viral-cellular contact for gene delivery in porous media.Proceedings of the National Academy of Sciences of the United States of America · 2026Article
- Laboratory Assessment and Clinical Outlook forAnnals of laboratory medicine · 2026Review
- Multi-omics reveal molecular changes during suspension adaptation of HEK293 cells.Applied microbiology and biotechnology · 2026Article
- Next-generation CAR-NK cell therapy: engineering strategies, translational challenges, and future perspectives in cancer immunotherapy.Cancer cell international · 2026Review
- Bioinspired and living multiscale composites for regenerative medicine in the treatment of surgical site infections.Journal of nanobiotechnology · 2026Review
- From production to bedside: A tiered QC framework for regulatory alignment and analytical comparability in decentralized CGT.Regenerative therapy · 2026Review
- Review
- Repurposing Tumor Cells: A Paradigm Shift in Cell-Based Therapies for Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Review
- DNA and RNA editing for the therapy of human diseases: current status, challenges, and future prospects.Molecular biomedicine · 2026Review
- Synthetic control of implanted engineered liver tissue growth.Science advances · 2026Article
- CAR-T cell therapy in breast cancer management: expanding horizon and overcoming challenges beyond hematologic cancers.Molecular biology reports · 2026Review
- Artificial Intelligence and the Transformation of Cell and Gene Therapy Development.Pharmaceutics · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The safety and efficacy of both cell and gene therapies have been demonstrated in numerous preclinical and clinical trials. Chimeric antigen receptor T (CAR-T) cell therapy, which leverages the technologies of both cell and gene therapies, has also shown great promise for treating various cancers. Advancements in pertinent fields have also highlighted challenges faced while manufacturing cell and gene therapy products. Potential problems and obstacles must be addressed to ease the clinical translation of individual therapies. Literature reviews of representative cell-based, gene-based, and cell-based gene therapies with regard to their general manufacturing processes, the challenges faced during manufacturing, and QC specifications are limited. We review the general manufacturing processes of cell and gene therapies, including those involving mesenchymal stem cells, viral vectors, and CAR-T cells. The complexities associated with the manufacturing processes and subsequent QC/validation processes may present challenges that could impede the clinical progression of the products. This article addresses these potential challenges. Further, we discuss the use of the manufacturing model and its impact on cell and gene therapy.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.