whitepaper
Press 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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Gene therapy
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What 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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Realising 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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Bioprocessing/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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European 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…
news
First gene therapy recommended for AADC
NICE's final draft guidance has recommended the first and only gene therapy for children with aromatic L-amino acid decarboxylase (AADC) deficiency.
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Novartis releases long-term data for SMA gene therapy
Long-term follow-up study data for Zolgensma®, Novartis’ one-time gene therapy for spinal muscular atrophy (SMA), has shown promising overall milestone achievements.
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GOSH and Leucid to manufacture novel CAR T therapy
Great Ormond Street Hospital and Leucid Bio will manufacture a novel lateral CAR targeting NKG2D ligands, under a first-of-its-kind manufacturing agreement.
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New NHS cell and gene therapy centre opens
The new Clinical Biotechnology Centre (CBC) in Bristol will manufacture cell and gene therapies to help boost the UK life sciences sector.
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EC approves first gene therapy for haemophilia B
The first gene therapy for haemophilia B has been given conditional marketing authorisation in Europe by the European Commission.
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EMA releases human medicines highlights 2022 report
Medicines which represented significant progress in their therapeutic areas have been listed in the European Medicines Agency's Human Medicines Highlights 2022 report.
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CGT Catapult to bolster new UK life sciences campus
The Cell and Gene Therapy Catapult (CGT Catapult) is set to be involved in the establishment of one of the largest life sciences campuses in Europe.
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FDA gives first RMAT designation to a cardiac gene therapy
A regenerative medicine advanced therapy (RMAT) designation has been given to a gene therapy for Danon disease by the US Food and Drug Administration (FDA).
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Video: Understanding current regulatory thinking on contamination control strategy
Virtual seminar presented by Ziva Abraham, President, and CEO of Microrite designed to improve your understanding on current regulatory thinking on designing an effective contamination control strategy.
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New UK point of care manufacturing regulatory framework
A first-of-its-kind regulatory framework for point of care manufacturing of innovative medicines is set to be introduced in the UK, ensuring these products are as safe as conventional medicines.
