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Advanced Therapy Medicinal Products

open access: yes
15211545In recent years advances in biology, biotechnology, and medical research have led to a new category of biologicals - the advanced therapy medicinal products (ATMPs).
Neuhaus, Vanessa   +2 more
core   +1 more source

Magnetically Driven Biofabrication for Tissue Engineering: From Nanoparticle Design to Mag‐ATMP Translation

open access: yesAdvanced Healthcare Materials, Volume 15, Issue 36, 25 September 2026.
Magnetically responsive nanoparticles enable remote control over biomaterials, cells, and engineered tissues. This review summarizes material design, biological safety, fabrication and actuation strategies, computational validation, and translational pathways that support the development of magnetic tissue‐engineering platforms and future magnetically ...
Konstantinos Ioannidis   +8 more
wiley   +1 more source

Advanced therapy medicinal products (ATMPs) & GMP : 10 years after

open access: yes, 2019
We review the GMP/regulatory experience with advanced therapy medicinal products (ATMPs) approximately 10 years after EC regulation 1394/2007, aka the ATMP regulation applied. Particularly, we discuss practical issues which have arisen during this period
Jossen, Valentin   +3 more
core  

Global regulatory frameworks and case studies of Advanced Therapy Medicinal Products (ATMPS)

open access: yesJournal of Rare Diseases
Purpose Advanced Therapy Medicinal Products (ATMPs), which include tissue-engineered products, gene therapies, and somatic cell therapies, are at the pioneering of healthcare discovery and have the potential to cure ailments for which there were ...
Sravanthi Siliveri, Kavya Sri Ausali
doaj   +1 more source

The clinical quality management system of advanced therapy medicinal products in the hospital setting: A scoping review

open access: yesMolecular Therapy: Methods & Clinical Development
Advanced therapy medicinal products (ATMPs) require rigorous quality management to mitigate risks associated with their development and use in hospitals.
Junnan Shi   +5 more
doaj   +1 more source

Phage Therapy Regulation: From Night to Dawn

open access: yesViruses, 2019
After decades of disregard in the Western world, phage therapy is witnessing a return of interest. However, the pharmaceutical legislation that has since been implemented is basically designed for regulating industrially-made pharmaceuticals, devoid of ...
Alan Fauconnier
doaj   +1 more source

Advanced Therapy Medicinal Products as Potential Therapeutic Strategy against COVID-19 and Immune-Related Disorders

open access: yes
Advanced Therapy Medicinal Products (ATMPs) comprise a heterogenous class of innovative medicinal products, which further require extensive preclinical and clinical assessments before their broader use in the general population [...
Panagiotis Mallis   +2 more
core   +1 more source

ARM’s Perspective on the First Joint Clinical Assessments for ATMPs: Challenges and Opportunities on the Path Ahead

open access: yesJournal of Market Access & Health Policy
Advanced Therapy Medicinal Products (ATMPs) are revolutionising modern medicine. By addressing the root cause rather than the symptoms of disease, ATMPs hold the promise of long-lasting benefits or even cures for severe, genetic, and rare diseases ...
Paolo Morgese   +2 more
doaj   +1 more source

Current challenges and future directions of ATMPs in regenerative medicine

open access: yesRegenerative Therapy
Advanced therapy medicinal products (ATMPs) represent a groundbreaking category of medications that utilize biological-based products to treat or replace damaged organs.
Fatemeh Abbasi Kakroodi   +6 more
doaj   +1 more source

What specificity for the clinical aspects of investigational advanced therapy medicinal products?

open access: yes, 2022
International audienceWhile Advanced Therapy Medicinal Products (ATMPs), a European legal classification of medicinal products based on genes, cells and tissues, raise specific quality issues, the latter are particularly acute in the context of clinical ...
Adja Fatou, Diack   +7 more
core  

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