Results 1 to 10 of about 24,822 (152)

Transitioning From Preclinical Evidence to Advanced Therapy Medicinal Product: A Spanish Experience [PDF]

Frontiers in Cardiovascular Medicine, 2021
A systematic and ordered product development program, in compliance with current quality and regulatory standards, increases the likelihood of yielding a successful advanced therapy medicinal product (ATMP) for clinical use as safe and effective therapy.
Paloma Gastelurrutia, Paloma Gastelurrutia, Paloma Gastelurrutia, Cristina Prat-Vidal, Cristina Prat-Vidal, Cristina Prat-Vidal, Joaquim Vives, Joaquim Vives, Joaquim Vives, Ruth Coll, Antoni Bayes-Genis, Antoni Bayes-Genis, Antoni Bayes-Genis, Antoni Bayes-Genis, Carolina Gálvez-Montón, Carolina Gálvez-Montón   +15 more
doaj   +4 more sources

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, Nina Harmening, Thais Bascuas, Sandra Johnen, Eline De Clerck, Verónica Fernández, Mattia Ronchetti, Ruggero Cadossi, Cristina Zanini, Daniel Scherman, Zoltán Ivics, Corinne Marie, Zsuzsanna Izsvák, Gabriele Thumann   +13 more
doaj   +4 more sources

Processing and Ex Vivo Expansion of Adipose Tissue-Derived Mesenchymal Stem/Stromal Cells for the Development of an Advanced Therapy Medicinal Product for use in Humans [PDF]

Cells, 2021
Adipose tissue (AT) represents a commonly used source of mesenchymal stem/stromal cells (MSCs) whose proregenerative potential has been widely investigated in multiple clinical trials worldwide.
Anna Labedz-Maslowska, Agnieszka Szkaradek, Tomasz Mierzwinski, Zbigniew Madeja, Ewa Zuba-Surma   +4 more
doaj   +4 more sources

Challenges in Advanced Therapy Medicinal Product Development: A Survey among Companies in Europe [PDF]

Molecular Therapy: Methods & Clinical Development, 2018
Advanced therapy medicinal products (ATMPs) hold promise as treatments for previously untreatable and high-burden diseases. Expectations are high and active company pipelines are observed, yet only 10 market authorizations were approved in Europe.
Renske M.T. ten Ham, Jarno Hoekman, Anke M. Hövels, Andre W. Broekmans, Hubert G.M. Leufkens, Olaf H. Klungel   +5 more
doaj   +4 more sources

Advanced Therapy Medicinal Products for the Eye: Definitions and Regulatory Framework [PDF]

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, Ana de la Mata, Sara Galindo, Francisco Blázquez, Margarita Calonge, Teresa Nieto-Miguel   +5 more
doaj   +6 more sources

Advanced therapy medicinal product (ATMP) classification – a case study on spinal cord injury [PDF]

Journal of Translational Medicine
Background The classification of Advanced Therapy Medicinal Products (ATMPs) within the European regulatory framework poses significant challenges, particularly when biomaterials are combined with viable cells, as in spinal cord injury (SCI) therapies ...
L. Duarte, M. Castellà, P. A. A. P. Marques, B. Gago   +3 more
doaj   +2 more sources

Basics of advanced therapy medicinal product development in academic pharma and the role of a GMP simulation unit [PDF]

Immuno-Oncology and Technology, 2023
Following successes of authorized chimeric antigen receptor T-cell products being commercially marketed in the United States and European Union, product development of T-cell-based cancer immunotherapy consisting of cell-based advanced therapy medicinal ...
I. Johanna, A. Daudeij, F. Devina, C. Nijenhuis, B. Nuijen, B. Romberg, C. de Haar, J. Haanen, H. Dolstra, E. Bremer, Z. Sebestyen, T. Straetemans, I. Jedema, J. Kuball   +13 more
doaj   +2 more sources

Preclinical Tumorigenicity Study of an Advanced Therapy Medicinal Product for Diffuse Cartilage Lesions in an Osteoarthritic Environment [PDF]

Cells
Background: Advanced therapy medicinal products require rigorous preclinical testing to exclude tumorigenicity. Human articular cartilage cells expanded at low density with human platelet lysate show enhanced proliferation, matrix production, and ...
Alessandra Colombini, Vincenzo Raffo, Vincenzo Pennone, Katia Mareschi, Luciana Labanca, Laura Mangiavini, Matteo Moretti, Camilla Recordati, Federico Armando, Laura de Girolamo, Arianna B. Lovati   +10 more
doaj   +2 more sources

Advanced therapy medicinal products in China: Regulation and development

MedComm, 2023
AbstractAdvanced 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 that encourage drug innovation. The capacity and efficiency of the Center for Drug Evaluation
Jiaqi Lu, Longchang Xu, Wei Wei, Wu He
exaly   +4 more sources

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 frameworks.
Enrico Fritsche, Petra Reinke, Leila Amini   +2 more
exaly   +4 more sources