ReviewMolecular therapy : the journal of the American Society of Gene Therapy2025
GMP manufacturing of cell and gene therapy products: Challenges, opportunities, and pathways forward.
Review in Molecular therapy : the journal of the American Society of Gene Therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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
8 citing papers in PubMed.
- Optimal Hypoxia Mimetic Small Molecules for Enhancing Angiogenic Properties of Stem Cells From Human Exfoliated Deciduous Teeth.International endodontic journal · 2026Article
- Engineered Neutrophils in Translational Medicine: Gene Editing, Nanotechnology, and AI-Driven Clinical Breakthroughs.Advanced healthcare materials · 2026Review
- Next-generation CAR-NK cell therapy: engineering strategies, translational challenges, and future perspectives in cancer immunotherapy.Cancer cell international · 2026Review
- Securing raw materials, reagents, and consumable supplies in the academic bioproduction UNITC network: because the chain is only as strong as its weakest link.Bone marrow transplantation · 2026Article
- Are All Cells Created Equal? Novel Cell-Based Regenerative Therapies in Inflammatory Bowel Disease.International journal of molecular sciences · 2026Review
- Microneedle-Assisted Cell Delivery and Therapy.Research (Washington, D.C.) · 2026Review
- Advances and challenges in immunotherapy and molecular imaging for hepatocellular carcinoma.Discover oncology · 2025Review
- Nanomaterials Application for STING Pathway-Based Tumor Immunotherapy.International journal of nanomedicine · 2025Review
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
Cell and gene therapy (CGT) products have been emerging as life-saving and life-changing therapies over the last 20 years. The United States has been a forerider in the development of these therapeutic products and has also developed the pertinent manufacturing methods for these complicated "living medicines." California has emerged as a prominent hub for CGT manufacturing, hosting a variety of good manufacturing practice (GMP) facilities. These facilities are pivotal in advancing CGT products from phase 1 to phase 3 clinical trials and, eventually, to commercialization. Despite California's strategic advantages, including its biotech ecosystem and access to venture capital, numerous challenges hinder its full potential. These include funding disparities, expertise limitations, stringent regulatory demands, and a mismatch between facility utilization and demand. This review explores these factors more in depth and provides a comprehensive analysis of the current state of GMP manufacturing for CGTs in California. The example of the current situation in the state of California may also serve as an analogy for other states; we chose California due to our decades of experience manufacturing CGT products in this state.
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.