ReviewImmuno-oncology technology2022
ATMP development and pre-GMP environment in academia: a safety net for early cell and gene therapy development and manufacturing.
Review in Immuno-oncology technology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 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
21 citing papers in PubMed.
- 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
- A decade of innovation in healthcare: Automation, bio-printing and digital twin technologies for personalized therapies.International journal of pharmaceutics: X · 2026Review
- Current capacity and gaps in viral vector manufacturing: a survey of centers associated with CTIWP of EBMT, NXTGEN-hightech, DARE-NL, T2EVOLVE, and GoCART coalition.Bone marrow transplantation · 2026Article
- Why advanced therapy medicinal products struggle in clinical translation: an in-depth analysis of developmental challenges in the EU.Frontiers in medicine · 2026Review
- Standard Methods for Quality Control in Cell-Based Medicinal Products and their Validation for Clinical Applications.Advanced biomedical research · 2026Review
- Defining core competencies for advanced therapy medicinal products translation.Frontiers in digital health · 2026Article
- The Advanced Therapies model of Lund an integrated approach to accelerate access for many patients.Molecular therapy. Methods & clinical development · 2025Article
- Extracorporeal Photopheresis: Does It Have a Potential Place Among Cell-based Therapies?Transplantation direct · 2025Article
- Redefining quality in cell and gene therapies: Lessons from implementing electronic QMS in academic cGMP facility.Molecular therapy : the journal of the American Society of Gene Therapy · 2025Review
- Callus organoids reveal distinct cartilage to bone transition mechanisms across donors and a role for biological sex.Bone research · 2025Article
- Machine Learning and Metabolomics Predict Mesenchymal Stem Cell Osteogenic Differentiation in 2D and 3D Cultures.Journal of functional biomaterials · 2024Article
- Bioengineering breakthroughs: The impact of stem cell models on advanced therapy medicinal product development.World journal of stem cells · 2024Review
- Developing Advanced Chimeric Cell Therapy for Duchenne Muscular Dystrophy.International journal of molecular sciences · 2024Article
- Advances in manufacturing chimeric antigen receptor immune cell therapies.Seminars in immunopathology · 2024Review
- Robotics-Driven Manufacturing of Cartilaginous Microtissues for Skeletal Tissue Engineering Applications.Stem cells translational medicine · 2024Article
- Powering prescription: Mitochondria as "Living Drugs" - Definition, clinical applications, and industry advancements.Pharmacological research · 2024Review
- Advanced Formulation Approaches for Emerging Therapeutic Technologies.Handbook of experimental pharmacology · 2024Article
- Basics of advanced therapy medicinal product development in academic pharma and the role of a GMP simulation unit.Immuno-oncology technology · 2023Review
- Evaluating Ecological Impact and Sustainability in the Manufacturing of Advanced Therapies: Comparative Analysis of Greenhouse Gas Emissions in the Production of ATMPs in Open and Closed Systems.Bioengineering (Basel, Switzerland) · 2023Article
- Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Advanced therapy medicinal products (ATMP) are medicines for human use that are based on genes, cells or tissues. Over the past years, an increasing number of ATMP entered the market for treatment of cancer, genetic disorders, skeletal defects and metabolic diseases. However, the ATMP production methods often change from the initial concept to commercialization. This change is needed to improve the manufacturing feasibility for scaling up or scaling out. Moreover, the production must adhere to current good manufacturing practices (GMP), and needs to follow a risk-based approach, which often is challenging to implement due to the novelty of the products. Since most of the early ATMP development is done in academia, an environment that is not familiar with regulatory requirements for ATMP production in GMP, the initial manufacturing choice for pre-clinical studies is usually very different from what is required for clinical use. This leads to a lengthy production process optimization, unnecessary repetition of experiments and ultimately waste of funding. This consideration prompted us to provide an intermediate step between early ATMP production in research settings to GMP manufacturing. We built a dedicated facility, and we called this environment 'pre-GMP' to highlight that it is a step toward preparation to GMP manufacturing. This environment supports process development and provides a manufacturing fitness room before transferring to GMP suites. This paper addresses the relevance of pre-GMP, underlining the advantages and the possible disadvantages of this additional framework that may be key in accelerating the pace of ATMP toward clinic.
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What Socratic 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 Socratic graph.