All drug products have to undergo sterility testing to comply with Good Manufacturing Practices (GMP). Rapid sterility testing, which offers an incubation period of five days or less, provides a solution.
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The UK MRC and LifeArc are making £16 million available as grants to fund the establishment of Gene Therapy Innovation Hubs to improve resources for researchers and manufacturers.
While medical professionals fight COVID-19 on the front line, small biotech businesses face a new uphill battle – maintaining research continuity for non-COVID-19 life-changing therapeutics.
Scientists have developed a protocol for encapsulating antibodies in an ultrasound-sensitive drug carrier for targeted drug delivery.
According to researchers, Zolgensma, made by Novartis, will lead the global spinal muscular atrophy market and generate billions in sales.
FLT190 gene therapy has been granted Orphan Drug Designation based on preliminary trial data and the positive opinion of an EMA committee.
New research has found that there are 362 cell and gene therapies in clinical pipelines in the US, an increase from 2018.
Arguments filed in opposition to a patent for foundation CRISPR-Cas9 intellectual property have been rejected by the European Patents Office.
The first US in-human trial of CRISPR-Cas9-edited T cells has concluded with no ill effects and showed that nine months later the infused cells were still active against cancer.
A skills demand report has stated that employment in the UK cell and gene therapy industry is expected to double by 2024, but must be supported by targeted academic courses.
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.
New research has found that the cell and gene therapy clinical environment in the UK has encouraged commercial sponsorship from around the world.
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.
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…