All Advanced therapies manufacturing articles – Page 10
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NewsReducing bioburden testing and sterility testing volumes for gene therapies
A reduced sampling plan was recommended in a Biophorum report for reducing required bioburden and sterility testing volumes for gene therapy batch yield.
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NewsGene therapy approved for Duchenne muscular dystrophy
The first approved gene therapy for certain paediatric Duchenne muscular dystrophy (DMD) patients leads to production of the Elevidys micro-dystrophin protein.
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NewsFDA approves off-the-shelf bispecific antibody cancer therapy
The US Food and Drug Administration (FDA) has approved the first bispecific antibody with a fixed-duration treatment in (R/R) diffuse large B-cell lymphoma (DLBCL).
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NewsCould novel gene therapy treat sickle cell disease?
Researchers have revealed positive preliminary data from a CRISPR gene therapy trial for sickle cell disease.
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NewsCell and Gene Therapy Catapult opens new laboratories
Cell and Gene Therapy Catapult's new laboratories in Scotland aims to help cell therapy developers improve their manufacturing processes and navigate regulatory requirements.
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ArticleThe cell and gene therapy CDMO bottleneck isn’t capacity – it’s capability
CDMOs have been squeezed by the sharp increase in companies preparing to scale their cell and gene therapy manufacturing for Phase III trials and commercialisation, and physical capacity has been a common scapegoat. But eXmoor CEO Angela Osborne says the real limiting factor is experience.
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NewsCRISPR-based microbial gene therapy delivers promise
A microbial gene therapy can “eliminate antibiotic-resistant E. coli strains in the gut”, according to first-in-human study interim results.
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NewsNanoparticle HIV vaccine shows potential in trial
Positive first-in-human trial results have highlighted potential of a nanoparticle vaccine towards broadly neutralising against HIV.
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NewsFirst redosable gene therapy approved
The “landmark approval” of a redosable gene therapy for dystrophic epidermolysis bullosa “ushers in a whole new paradigm to treat genetic diseases".
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ArticleRecent developments in stem cell therapies
EPR explores recent developments in stem cell therapies across several hard-to-treat diseases and how technology is transforming ATMP manufacture.
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NewsCould personalised mRNA vaccine be first for cancer?
Half of pancreatic ductal adenocarcinoma (PDAC) patients given a personalised mRNA neoantigen vaccine experienced delayed recurrence 18 months post-vaccination.
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ArticleRealising milestones with gene therapy for SMA
Novartis Gene Therapies' Vice President for Clinical Development & Analytics shares what shaped the success of one of the few commercially-available gene therapies.
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WhitepaperPress release: SGS wins business leadership award 2023
SGS’s biosafety centre of excellence in Glasgow has received the Business Leadership Award at Scotland's Life Sciences Annual Awards 2023.
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NewsBristol Myers Squibb boosts CAR T therapy manufacturing capabilities
Securing in-house viral vector production capabilities in the US is set to help Bristol Myers Squibb manufacture its two CAR T-cell therapies.
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ArticleWhat gene therapy manufacturers can gain from collaboration
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.
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ArticleRealising the potential of AAV 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.
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ArticleBioprocessing/Bioproduction In-Depth Focus 2023
In this In-Depth Focus are articles on the potential of AAV gene therapies and what gene therapy manufacturers can gain from collaboration.
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ArticleEuropean Pharmaceutical Review Issue 2 2023
EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…
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NewsYescarta® demonstrates promising European manufacturing experience
In newly published analysis, Kite's CAR T-cell therapy delivered a reduced median European manufacturing turnaround time for diffuse large B-cell lymphoma (DLBCL) patients.
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NewsFDA approves allogeneic stem cell transplant therapy
The first allogeneic stem cell transplant therapy to be approved based on Phase III study results has been granted by the US Food and Drug Administration (FDA).