All Advanced therapies manufacturing articles – Page 2
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News
Boehringer Ingelheim signs gene therapy manufacturing deal with AnGes
The German pharma company’s BioXcellence arm will supply the drug substance for AnGes’ peripheral arterial disease treatment Collategene.
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NewsNanoscope gene therapy data signals potential retinal disease advancement
Further to its potential in Stargardt disease, if approved, the one-time gene therapy could become standard of care for retinitis pigmentosa, alongside other retinal degenerative diseases.
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NewsT-cell engagers set to drive immuno-oncology market
Amid intensifying market competition, the next-generation therapies could shape the future of oncology.
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NewsVinay Prasad returns to lead vaccines and cell and gene therapy at the FDA
CBER head makes surprise comeback just weeks after his abrupt resignation.
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WebinarBest practices for PUPSIT assembly design and operation
This webinar explores the design and implementation of pre use post sterilisation integrity test assemblies (PUPSIT) in sterile filtration processes to ensure regulatory compliance while minimising operational risk.
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Article
Amid FDA turmoil Sarepta’s gene therapy worries begin to ease
But the impact of George Tidmarsh’s CBER appointment after Vinay Prasad’s abrupt resignation remains to be seen.
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NewsStanford research illustrates safer stem cell transplants for genetic disease
The innovative protocol could improve stem cell transplants and make them safer, enabling a broader disease population to take advantage of the benefits.
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NewsWorld-first legislation backs decentralised manufacturing
The landmark regulation establishes a future where highly personalised treatments are part of routine care, says MHRA’s Chief Executive.
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NewsGene therapy could improve genetic deafness
The study represents the first time the injectable gene therapy has been evaluated in teenagers and adults.
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ArticleA rapid microbiological method case study for advanced therapy medicinal products
In this article, Stacey Ramsey, Senior Manager – Microbial Applications Lab, Charles River Laboratories, discusses the modernisation of rapid microbiological methods (RMMs) and the potential of ATP-bioluminescence when testing cell-based products.
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WebinarHarnessing AI to transform quality and manufacturing in life sciences
This webinar explores innovative, purpose-built AI solutions that elevate compliance and efficiency in quality and manufacturing operations.
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NewsAbbVie immunology deal to advance potential first-in-class therapy
The new acquisition, worth up to $2.1 billion, gives AbbVie rights to a potential first-in-class drug for B cell-mediated autoimmune diseases.
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ReportStreamlining European expansion for cell and gene therapies
Tom Smith, Strategic Director, Cell and Gene Therapies, Uniphar, discusses the essential elements biotechs need for commercial success in Europe’s unique market when developing cell and gene therapies (CGTs).
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NewsiPSC-CAR-NK cell therapy exhibits autoimmune potential
The genetically edited allogeneic product could serve as an immune-modulatory therapy for severe autoimmune diseases, data suggests.
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NewsRegulatory shift signals potential change for future CGT sector
The cell and gene therapy (CGT) sector must maintain its scientific rigor despite recent changes to US policy and market conditions, says key industry body.
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NewsEli Lilly genetic medicine acquisition to address cardiovascular risk
The agreement between Eli Lilly and Company and Verve Therapeutics could lead the way to single treatments that provide a long-term reduction of cardiovascular risk factors.
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NewsDuchenne gene therapy interim trial outcomes “striking”
The gene therapy demonstrated consistent evidence of positively changing disease trajectory in Duchenne muscular dystrophy, new interim data shows.
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NewsR&D and tech innovation boosting biopharmaceutical market to 2030
Advanced technology innovation is driving lower R&D costs and progress of targeted treatments such as cell and gene therapies, the research reports.
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WhitepaperStrategies for endotoxin testing of RNA-LNP
Overcome matrix interferences in RNA–LNP endotoxin testing with LAL-based methods & recombinant factor C assays. Learn more in this whitepaper.
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NewsNew technology could enhance CAR T therapy manufacture
The innovative device could improve CAR T cell cancer immunotherapy and facilitate its use as a first-line therapy, research suggests.