All Advanced therapies manufacturing articles – Page 4
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NewsAAV gene therapy manufacturing gets £1.4m boost
The funding aims to reduce the costs of AAV production for gene therapies, helping to accelerate treatment access for patients with rare diseases.
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NewsFirst real-world study reveals encouraging efficacy for cell therapy
More than half of the multiple myeloma patients included in this study would have been ineligible for the Phase II CARTITUDE-1 clinical trial, research reports.
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ArticleQuality from the start: designing a scalable AAV production platform
This Feature Partnership discusses AAVs and how manufacturers can overcome the key development challenges and create a scalable AAV production platform.
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NewsEuropean manufacturing facility to strengthen gene therapy supply
The new manufacturing facility in Finland will aid global supply of the first FDA-approved intravesical non-replicating gene therapy for adults with a common cancer.
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WebinarMonocyte activation test (MAT): Insight into examining regulations and markets prospects
Watch this webinar to learn about the current regulations on the monocyte activation test (MAT) and the new type of MAT entering the markets.
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NewsGene therapy trial facilitates major vision improvement
Some of the rare disease participants experienced fast and sustained improvement in their eyesight during the clinical trial, data shows.
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WebinarAn alternative medium to support sterility testing using the Growth Direct® Rapid Sterility System
Watch on demand to learn how a new single medium, Rapid Sterility Medium (RSM), performs as well as or better for the growth promotion of test microorganisms compared to compendial sterility test media.
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NewsEnhancing cell proliferation in bioproduction with non-invasive technology
The method has potential in both biomanufacturing and production of autologous cell therapies, the research suggests.
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ArticleRegulating therapies for rare diseases – recent approvals
This article summarises some of the recent notable drug approvals in the EU and US, including a gene therapy and an enzyme replacement therapy.
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NewsFDA approves innovative engineered cell therapy
The accelerated approval by the US Food and Drug Administration (FDA) authorises the first engineered cell therapy for a solid tumour in the US.
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ArticleAlzheimer’s drug development roundup – July 2024
From exciting data on cell therapy and monoclonal antibodies, through to new regulatory developments, this article summarises some of the key developments within the Alzheimer’s therapeutic landscape over July.
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NewsPfizer receives EU haemophilia B gene therapy approval
The single-dose gene therapy was approved for certain patients with haemophilia B in the US and Canada earlier this year, marketed as BEQVEZ.
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ArticleThe route to enhanced gene therapies
In this article, Roger Palframan, Head of US Research at UCB, delves into the potential of gene therapy and which modalities have the most promise, what the industry should prioritise to advance the field, as well as what is needed to develop the workforce.
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News‘Accidental’ media switch leads to CAR T therapy discovery
The investigators hope that their new approach could lead to large-scale manufacturing of the CAR T cells for blood cancer patients.
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WhitepaperApplication note: Automated nucleic acid amplification assay for mycoplasma detection in cell and gene therapy products
Ambili Menon, Pharma Quality Control, bioMérieux Inc. addresses the task of microbiological testing for advanced therapeutic medicinal products.
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ArticleDrug approval roundup – May/June 2024
This article highlights some of the key regulatory approvals granted in May and June in the EU and US so far this year, including for oligonucleotide and biologic therapies.
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WhitepaperOne HEK of a viral vector to develop
Viral vector manufacturing presents many challenges related to HEK cell line development, fluid transfer and product viability in the cold chain.
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ArticleModifier gene therapy - clinical development and manufacturing considerations
Expanding on his earlier podcast discussion with EPR, Dr Arun Upadhyay, Chief Scientific Officer and Head of Research & Development at Ocugen, discusses the company’s promising modifier gene therapy candidates for ophthalmic disorders.
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ArticleAdvancing targeted treatments for multiple myeloma
Edmond Chan, Senior Director, EMEA Therapeutic Area Lead, Haemato-Oncology, Johnson & Johnson Innovative Medicines, offers insight into the promising evidence of cell therapies and biologic-based treatments for patients with multiple myeloma.
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ArticleFresh or frozen? Navigating the cryopreservation dilemma for CGT
Cell and gene therapy development grapples with a paradox: fresh starting material is often equated with higher-quality drug products, but cryopreservation is crucial for scale-up. In fact, every approved autologous cell-based therapy relies on freezing cells. Reconciling these truths can be key for the success of any commercial therapy based ...