Results 11 to 20 of about 7,238,985 (145)

Innovation and competition in advanced therapy medicinal products [PDF]

EMBO Molecular Medicine, 2019
Graphical Abstract Advanced therapy medicinal products (ATMPs), including gene therapy, cell therapy and tissue engineering products, represent a paradigm shift in health care, but they are expensive. E. Seoane‐Vazquez, V. Shukla and R. Rodriguez‐Monguio
Enrique Seoane‐Vazquez, Vaishali Shukla, Rosa Rodriguez‐Monguio   +2 more
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Advanced Therapy Medicinal Products' Translation in Europe: A Developers' Perspective [PDF]

Frontiers in Medicine, 2022
Advanced Therapy Medicinal Products (ATMPs) comprising cell, gene, and tissue-engineered therapies have demonstrated enormous therapeutic benefits. However, their development is complex to be managed efficiently within currently existing regulatory ...
Maja Pizevska, Jaspal Kaeda, Enrico Fritsche, Hisham Elazaly, Petra Reinke, Petra Reinke, Leila Amini, Leila Amini   +7 more
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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, B. K. Romanov, A. N. Yavorsky, N. D. Bunyatyan, V. A. Merkulov, A. N. Mironov   +5 more
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The Relevance of Advanced Therapy Medicinal Products in the Field of Transplantation and the Need for Academic Research Access: Overcoming Bottlenecks and Claiming a New Time

Transplant International, 2023
The field of transplantation has witnessed the emergence of Advanced Therapy Medicinal Products (ATMPs) as highly promising solutions to address the challenges associated with organ and tissue transplantation.
Lorenzo Piemonti, Hanne Scholz, Dide de Jongh, Dide de Jongh, Julie Kerr-Conte, Aart van Apeldoorn, James A. M. Shaw, Marten A. Engelse, Eline Bunnik, Markus Mühlemann, Karolina Pal-Kutas, William E. Scott, Jérémy Magalon, Jérémy Magalon, Patrick Kugelmeier, Ekaterine Berishvili   +15 more
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Potency assays and biomarkers for cell-based advanced therapy medicinal products

Frontiers in Immunology, 2023
Advanced Therapy Medicinal Products (ATMPs) based on somatic cells expanded in vitro, with or without genetic modification, is a rapidly growing area of drug development, even more so following the marketing approval of several such products.
Chiara Capelli, Carolina Cuofano, Chiara Pavoni, Simona Frigerio, Daniela Lisini, Sara Nava, Michele Quaroni, Valentina Colombo, Francesco Galli, Svetlana Bezukladova, Svetlana Bezukladova, Paola Panina-Bordignon, Paola Panina-Bordignon, Giuseppe Gaipa, Patrizia Comoli, Giulio Cossu, Giulio Cossu, Gianvito Martino, Gianvito Martino, Andrea Biondi, Andrea Biondi, Martino Introna, Josée Golay   +22 more
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The Marketing Authorisation of Advanced Therapy Medicinal Products under the regulation of the European Union

, 2023
International audienceAdvanced Therapy Medicinal Products (ATMPs) is a European classification of medicinal products based on genes, cells and tissues specifically regulated in the European Union (EU) from the entry into force of Regulation (EC) No 1394 ...
Delage, Auxane, Nègre, Olivier, Mahalatchimy, Aurélie, Gilbert, Luc-Sylvain   +3 more
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Comparative quality aspects of gene therapy medicinal products and medicinal products containing genetically modified cells

, 2022
International audienceThe European Medicines Agency has recently revised its guidelines on quality, non-clinical and clinical aspects of Gene Therapy Medicinal Products (GTMPs text) and of medicinal products containing genetically modified cells (GMCMPs ...
Morrison, Michael, Sabatier, Florence, Andrieu, Véronique, Feraud, Marion, Veran, Julie, Mahalatchimy, Aurélie, Gennet, Éloïse, Lacaille, Victoire   +7 more
core   +5 more sources

Cell-based medicinal products approved in the European Union: current evidence and perspectives

Frontiers in Pharmacology, 2023
Advanced Therapy Medicinal Products (ATMPs) are innovative clinical treatments exploiting the pharmacological, immunological, or metabolic properties of cells and/or gene(s) with the aim to restore, correct, or modify a biological function in the ...
Stefania Bellino, Anna La Salvia, Maria Francesca Cometa, Rosanna Botta   +3 more
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Production Aspects of Advanced Therapy Medicinal Products

, 2022
International audienceBackground : Good Manufacturing Practice (GMP) guidelines established by the European Commission are essential to ensure quality, safety and efficacy of medicinalproducts.
Morrison, Michael, Sabatier, Florence, Andrieu, Véronique, Veran, Julie, Mahalatchimy, Aurélie, Gennet, Éloïse, Le Corre, Carla, Santos- Peixoto, Carlota   +7 more
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Is the Conjunctiva a Potential Target for Advanced Therapy Medicinal Products?

Pharmaceutics, 2021
The conjunctiva is a complex ocular tissue that provides mechanical, sensory, and immune protection for the ocular surface. It is affected by many diseases through different pathological mechanisms.
Yolanda Diebold, Laura García-Posadas
doaj   +1 more source