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AAV development for cell and gene therapy in 2023 is being impacted by manufacturing and regulation challenges, however advancing technologies offer opportunity, according to leaders in the field.
12 July 2023 | By Altasciences
Understanding the different regulatory pathways available is critical to getting your drug to market as quickly and safely as possible.
The first approved gene therapy for haemophilia A reduced the mean annualised bleeding rate from 5.4 bleeds to 2.6 bleeds per year in a clinical study.
EPR Issue 3 includes articles the role of titanium dioxide in pharmaceutical formulations, bioprocessing innovations for cell and gene therapies, manufacturing of radiotheranostics and more …
A reduced sampling plan was recommended in a Biophorum report for reducing required bioburden and sterility testing volumes for gene therapy batch yield.
The first approved gene therapy for certain paediatric Duchenne muscular dystrophy (DMD) patients leads to production of the Elevidys micro-dystrophin protein.
Researchers have revealed positive preliminary data from a CRISPR gene therapy trial for sickle cell disease.
Cell and Gene Therapy Catapult's new laboratories in Scotland aims to help cell therapy developers improve their manufacturing processes and navigate regulatory requirements.
A microbial gene therapy can “eliminate antibiotic-resistant E. coli strains in the gut”, according to first-in-human study interim results.
The “landmark approval” of a redosable gene therapy for dystrophic epidermolysis bullosa “ushers in a whole new paradigm to treat genetic diseases".
Novartis Gene Therapies' Vice President for Clinical Development & Analytics shares what shaped the success of one of the few commercially-available gene therapies.
SGS’s biosafety centre of excellence in Glasgow has received the Business Leadership Award at Scotland's Life Sciences Annual Awards 2023.
In this article, Neil Almstead, Chief Technical Operations Officer at PTC Therapeutics, shares his view on why collaboration is key to streamlining manufacture of gene therapies.
In this article, Dr Rajiv Vaidya, Head of Manufacturing Science & Technology at Andelyn Biosciences, explores strategies for improving the scalability and cost‑effectiveness of AAV production while maintaining regulatory compliance.
In this In-Depth Focus are articles on the potential of AAV gene therapies and what gene therapy manufacturers can gain from collaboration.
