Results 61 to 70 of about 1,892 (131)

Tips and Tricks for Validation of Quality Control Analytical Methods in Good Manufacturing Practice Mesenchymal Stromal Cell Production

Stem Cells International, 2018
Mesenchymal stromal cells (MSC) for cellular therapy in European Union are classified as advanced therapy medicinal products (ATMPs), and their production must fulfill the requirements of Good Manufacturing Practice (GMP) rules.
Mariele Viganò, Silvia Budelli, Cristiana Lavazza, Tiziana Montemurro, Elisa Montelatici, Stefania de Cesare, Lorenza Lazzari, Anna Rosa Orlandi, Giovanna Lunghi, Rosaria Giordano   +9 more
doaj   +1 more source

Impact of regulatory measures on the approval timelines of advanced therapy medicinal products by the European Medicines Agency. [PDF]

Front Med (Lausanne)
IntroductionThe study examines the impact of regulatory tools, including PRIority MEdicines (PRIME) scheme, on the marketing authorization (MA) timeline of advanced therapy medicinal products (ATMPs) approved by the European Medicines Agency (EMA ...
Alaburde S, Ivaska J, Kaspute G, Ivaskiene T.   +3 more
europepmc   +2 more sources

Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States

Frontiers in Pharmacology, 2019
Advanced therapy medicinal products (ATMPs) are a fast-growing field of innovative therapies. The European Union (EU) and the United States (US) are fostering their development.
Carolina Iglesias-Lopez, Antonia Agustí, Antonia Agustí, Mercè Obach, Antonio Vallano, Antonio Vallano   +5 more
doaj   +1 more source

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

Journal 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

Advancing ATMPs for orphan diseases: redefining the roles of pharmaceutical companies and academia

Blood Immunology & Cellular Therapy
: Advanced therapy medicinal products (ATMPs), including gene, cell, and tissue-engineered therapies, have transformed the treatment landscape for rare hematological, metabolic, and immunological conditions, yet face persistent barriers to market access ...
Ana Hidalgo Simon, Claire Booth
doaj   +1 more source

Advanced therapy medicinal products in Saudi Arabia: Regulation and development. [PDF]

Regen Ther
AlMuhanna MH, Alharbi M, Aldahash A, Felemban R, Asiri L, Alghamdi M, Alzahrani R, Aldossary W, Alenzi N, Almohaywi M.   +9 more
europepmc   +1 more source

Expanding Patient Access to Advanced Therapies. [PDF]

BioDrugs
Guillen E, Hidalgo-Simon A.
europepmc   +1 more source

Individualized pharmacotherapy: background and development. [PDF]

Ann Transl Med
Jørgensen JT, Westergaard N.
europepmc   +1 more source

Advanced therapy medicinal products (ATMPs) - An analysis of the global regulatory status. [PDF]

Br J Clin Pharmacol
Cramer A, Sørup FKH, Lund M, Petersen TS, Karstoft K.   +4 more
europepmc   +1 more source

Why advanced therapy medicinal products struggle in clinical translation: an in-depth analysis of developmental challenges in the EU. [PDF]

Front Med (Lausanne)
Van Isterdael C, Mugarza E, Fischer P, Debackere K, Vandenberghe P, Martin Lluesma S, Van Eldere J, Huys I.   +7 more
europepmc   +1 more source