GMP-Grade Manufacturing and Quality Control of a Non-Virally Engineered Advanced Therapy Medicinal Product for Personalized Treatment of Age-Related Macular Degeneration [PDF]
Biomedicines, 2022 The introduction of new therapeutics requires validation of Good Manufacturing Practice (GMP)-grade manufacturing including suitable quality controls. This is challenging for Advanced Therapy Medicinal Products (ATMP) with personalized batches.
Martina Kropp +13 more
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Advanced therapy medicinal products in China: Regulation and development
MedComm, 2023 Advanced therapy medicinal products (ATMPs) have shown dramatic efficacy in addressing serious diseases over the past decade. With the acceleration and deepening of China's drug regulatory reforms, the country sees a continuous introduction of policies ...
Jiaqi Lu, Longchang Xu, Wei Wei, Wu He
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Advanced Therapy Medicinal Products (ATMP)and exemptions to the Regulation 1394/2007: how confident can we be? An exploratory analysis. [PDF]
Frontiers in Pharmacology, 2012 The market authorisation procedure for medicinal products for human use is relying on their demonstrated efficacy, safety and pharmaceutical quality. This applies to all medicinal products whether of chemical or biological origin. Since October 2009, the
Philippe eVan Wilder
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Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe [PDF]
Frontiers in Medicine, 2017 In 2008, the European Union introduced the Advanced Medicines Regulation aiming to improve regulation of advanced therapy medicinal products (ATMPs).
Andreas M. Farkas +8 more
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Methodological Approaches to Risk Management of Advanced Therapy Medicinal Products [PDF]
Разработка и регистрация лекарственных средств, 2023 Introduction. Advanced therapy medicinal products (ATMPs) rely on recent advances in medical science, but alongside with potential benefits they may also bring safety concerns for patients. The inherent complexity of the ATMP production and use calls for
A. A. Taube, N. Yu. Velts
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RISK ASSESSMENT OF ADVANCED THERAPY MEDICINAL PRODUCTS [PDF]
Безопасность и риск фармакотерапии, 2018 Advanced therapy medicinal products (ATMP) represent a heterogeneous group of medicinal products, combined with the need for special regulation of their circulation.
R. N. Alyautdin +5 more
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Advanced Therapy Medicinal Products for the Eye: Definitions and Regulatory Framework
Pharmaceutics, 2021 Advanced therapy medicinal products (ATMPs) are a group of innovative and complex biological products for human use that comprises somatic cell therapy medicinal products, tissue engineered products, gene therapy medicinal products, and the so-called ...
Marina López-Paniagua +5 more
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Why advanced therapy medicinal products struggle in clinical translation: an in-depth analysis of developmental challenges in the EU [PDF]
Frontiers in MedicineAdvanced Therapy Medicinal Products (ATMPs) can offer unprecedented therapeutic benefit for patients with limited treatment options. However, their clinical translation and early-stage clinical development remain highly complex, particularly for academic
Charlotte Van Isterdael +8 more
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Translational research on advanced therapies
Annali dell'Istituto Superiore di Sanità, 2011 Fostering translational research of advanced therapies has become a major priority of both scientific community and national governments. Advanced therapy medicinal products (ATMP) are a new medicinal product category comprising gene therapy and cell ...
Filippo Belardelli +5 more
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Cell therapy medicinal product regulatory framework in Europe and its application for MSC based therapy development [PDF]
Frontiers in Immunology, 2012 Advanced therapy medicinal products (ATMPs), including cell therapy products, form a new class of medicines in the European Union. Since ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for
Janis eAncans
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