news
World-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.
List view / Grid view
Gene therapy
news
Gene therapy could improve genetic deafness
The study represents the first time the injectable gene therapy has been evaluated in teenagers and adults.
article
A 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.
webinar
Harnessing AI to transform quality and manufacturing in life sciences
2 July 2025 | By MasterControl
This webinar explores innovative, purpose-built AI solutions that elevate compliance and efficiency in quality and manufacturing operations.
article
Streamlining 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).
news
Regulatory 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.
news
Eli 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.
news
Duchenne 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.
news
R&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.
whitepaper
Strategies 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.
article
Pharma Horizons: the future of cell and gene therapy
This exclusive report addresses the key challenges and breakthroughs shaping the future of cell and gene therapy, from QC and analytical development to advanced manufacturing strategies. Discover practical solutions you can implement to drive progress for your organisation.
news
FDA approves first-of-a-kind gene therapy for dystrophic epidermolysis bullosa
With clinical data showing the gene therapy can address large and challenging chronic wounds, the FDA’s decision will help improve quality of life for dystrophic epidermolysis bullosa (DEB) patients.
news
USP boosts support for AAV-based gene therapy manufacturers
Alongside publication of the proposed General Chapter < 1067 >, the new resources from USP aim to help advance AAV gene therapies.
webinar
Advancing endotoxin testing: implementing sustainable recombinant LAL solutions
7 March 2025 | By Fujifilm Wako
Discover the benefits of sustainable recombinant LAL for endotoxin testing. Learn about its relevance, selection considerations, and seamless integration into your lab processes with expert insights.
news
CHMP meeting highlights – February 2025
The Committee for Medicinal Products for Human Use (CHMP) recommended approval of four new medicines plus the extension of therapeutic indications for 16 medicines.
