Results 51 to 60 of about 7,238,985 (145)
Cell and Gene Therapies: European View on Challenges in Translation and How to Address Them
Frontiers in Medicine, 2018 Advanced therapy medicinal products (ATMPs), i.e., cell and gene therapy products, is a rapidly evolving field of therapeutic development. A significant proportion of the products are being developed by academia or small/medium-sized enterprises (SMEs ...
Cécile F. Rousseau +6 more
doaj +1 more source
Barriers to Treg therapy in Europe: From production to regulation
Frontiers in Medicine, 2023 There has been an increased interest in cell based therapies for a range of medical conditions in the last decade. This explosion in novel therapeutics research has led to the development of legislation specifically focused on cell and gene based ...
Conor Hennessy +4 more
doaj +1 more source
Regulatory harmonization: Evolution, globalization and future directions
British Journal of Clinical Pharmacology, EarlyView.Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm +2 more
wiley +1 more source
Advanced therapy medicinal products (ATMPs) & GMP : 10 years after
, 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 +1 more source
Capacity building in medicines development and regulation in Africa—Overview on recent progress
British Journal of Clinical Pharmacology, EarlyView.Aims Despite advances in health research and digital innovation, many African countries continue to face substantial resource constraints, fragmented capacity‐building efforts and a shortage of skilled professionals in medicines development and regulatory science.
Tirhani Maluleke +7 more
wiley +1 more source
Quality control and batch release aspects of Advanced Therapy Medicinal Products
, 2022 International audienceQuality control and batch release raise specific challenges for ensuring quality and complying with regulatory requirements in order to obtain manufacturing and marketing authorizations for Advanced Therapy Medicinal Products (ATMPs)
Morrison, Michael +7 more
core +5 more sources
What Makes an “Ideal” Cell Line for Recombinant Adeno‐Associated Virus Production?
Biotechnology and Bioengineering, EarlyView.Several host cell types have been used to produce rAAVs to date. Cell line‐specific traits that are beneficial in the context of rAAV manufacturing are reviewed here, with the goal of developing a consensus on the ‘ideal’ characteristics that an rAAV production host should possess (created with Biorender.com).
James Conheady +6 more
wiley +1 more source
Regenerative Therapy, 2018 “Compassionate use” or “Hospital exemption” provides an important pathway for patients with life-threatening conditions to gain access to unproved human cells and tissue products.
Kazuo Yano, Masayuki Yamato
doaj +1 more source
Frontiers in Public Health, 2021 Some advanced therapy medicinal products (ATMPs) hold great promises for life-threatening diseases with high unmet needs. However, ATMPs are also associated with significant challenges in market access, which necessitates the joint efforts between all ...
Tingting Qiu +5 more
doaj +1 more source
Biotechnology and Bioengineering, EarlyView.Lifecycle perspective on cell and gene therapy manufacturing challenges and enabling GMP solutions. ABSTRACT Cell and gene therapies (CGTs) are revolutionizing modern medicine; however, making these advanced medicines scalable and readily available to commercial manufacturers worldwide is a major challenge. The number of approved CGT products continues
Rajath Samaga +2 more
wiley +1 more source