All Advanced therapies manufacturing articles – Page 10
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ArticleThe evolution of AAVs in cell and gene therapy
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.
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ArticlePreparing for stricter standards on substances of human origin
Manufacturers of innovative therapies and other stakeholders handling blood, tissues and cells must prepare for stronger European rules. Ulf Grundmann, Elisabeth Kohoutek and Lara Sophie Hucklenbroich of King & Spalding elaborate on what this means for manufacturers of advanced therapy medicinal products.
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Webinar
Determining the right regulatory pathway for your drug
Understanding the different regulatory pathways available is critical to getting your drug to market as quickly and safely as possible.
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NewsBispecific antibody approved in Europe for DLBCL
European approval of the bispecific antibody treatment has the potential to change the current standard of care in diffuse large B-cell lymphoma (DLBCL).
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NewsFirst gene therapy approved for Haemophilia A
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.
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NewsFirst cell therapy approved for Type 1 diabetes
US Food and Drug Administration (FDA)-approved allogeneic pancreatic islet cell therapy Lantidra could provide another treatment option for Type 1 diabetes.
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NewsLonza and Vertex to partner to manufacture diabetes cell therapies
The proposed collaboration between Lonza and Vertex Pharmaceuticals will support manufacture of stem cell-derived, fully differentiated insulin-producing islet diabetes cell therapies.
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ArticleEuropean Pharmaceutical Review Issue 3 2023
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 …
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NewsFirst RNA CAR-T therapy autoimmunity trial shows potential
A novel RNA CAR-T cell therapy demonstrated long-term clinical benefit for most generalised myasthenia gravis (gMG) patients in a landmark study.
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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.