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FDA releases guidance on gene therapy manufacturing
In an effort to support innovation in the development of gene therapy products, the FDA has released guidance to provide regulatory clarity for product developers.
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Gene therapy
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UK accounts for 12 percent of global cell and gene therapy clinical trials
New research has found that the cell and gene therapy clinical environment in the UK has encouraged commercial sponsorship from around the world.
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Nanoparticle gene therapy drug delivery for paediatric brain cancer tested in mice
A study has shown that PBAE nanoparticles could replace viral vectors in gene therapies and provide a safe treatment option for paediatric brain cancer patients.
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Viral vectors for gene therapy
The first gene therapy products are appearing commercially and the field is growing rapidly with over 350 clinical trials taking place in H1 of 2019 alone. So why is this area attracting so much attention? Dr Philip Probert and Dr Stuart Jamieson discuss the potential of gene therapy and the…
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Bioprocessing & Bioproduction In-Depth Focus 2019
Within this in-depth focus are articles exploring the potential of gene therapies and manufacturing viral vectors as well as a discussion on recent M&As within the biopharmaceutical industry.
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Investment in UK cell and gene therapy manufacturing set to continue
An additional 6,000m2 of cell and gene therapy manufacturing space is expected to become available within the next 12 months, according to new data.
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UK authorisation granted for first in-human CAR-Treg cell therapy study
Authorisation has been granted in the UK for the STEADFAST clinical study of TX200, which is the first-in-human trial to evaluate a CAR-Treg cell therapy.
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CAR-T cell therapy granted RMAT for relapsed/refractory multiple myeloma
An investigational CT053 CAR-T cell therapy for RRMM has been given Regenerative Medicine Advanced Therapy designation.
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New report predicts growth of gene therapies for neurology indications
A new report has predicted that gene therapy development will pick up pace but a high price point continues to pose a challenge.
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Clinical trial shows cell therapy could be safe for liver disease patients
A new cell therapy has been tested in patients with liver cirrhosis and found no significant adverse effects.
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Alternative viral delivery of gene therapy developed
New nanocapsules are a promising platform for many types of gene therapies due to their small size and superior stability.
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BPSA releases guide to production of cell and gene therapies
The Bio-Process Systems Alliance, the primary international industry association for single-use bio-processing, is pleased to announce the release of its latest whitepaper...
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Gene therapy receives Champalimaud Vision Award
The Champalimaud Vision Award has been awarded to research teams for the development of a gene therapy...
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Regulatory, clinical and logistics challenges of Advanced Therapy Medicinal Products (ATMPs) in clinical research
Advanced Therapy Medicinal Products (ATMPs) are new therapeutics that require different procedures for clinical trials compared to traditional medicinal products. It is important to understand the nature and the manufacturing process of an ATMP for set-up and execution of the clinical development and later marketing of these therapies.
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FDA approves CAR T cell therapy for children with leukaemia
The FDA has approved CAR T cell therapy for treatment of children with acute lymphoblastic leukemia...
