Featured content
Managing nitrosamine toxicological risk in late-stage development
When a nitrosamine drug substance-related impurity (NDSRI) is newly identified or increases above established control levels, opportunities for chemistry, manufacturing and control (CMC) mitigation may be limited. Toxicological assessment and impurity mitigation must therefore proceed in parallel. Alex Gauthier at Novartis reviews practical toxicological strategies for managing late-stage NDSRIs while maintaining patient safety and development timelines.
ReportPharma Horizons: Formulation
Discover the key technologies, risk mitigation strategies and development considerations shaping modern pharmaceutical formulation — from early-stage selection through to commercial-scale manufacturing.
ArticleEuropean Pharmaceutical Review Issue 2 2026
EPR Issue 2 includes articles on manufacturing, drug formulation, microbiology, downstream bioprocessing, and more.
ArticleWhy authenticity is key for biopharma leaders
Drawing on more than 20 years in the industry and a few unexpected lessons, CPHI Awards 2026 – Woman of the Year finalist, FUJIFILM Biotechnologies’ President and Chief Operating Officer Maja Pedersen, reflects on how leading as your authentic self produces better outcomes for teams, organisations and patients.
News
News​FDA finalises cell and gene therapy potency guidance
The FDA has issued final guidance outlining a science- and risk-based approach to potency assurance for CGT products, replacing its previous 2011 recommendations and setting out expectations across the product lifecycle.
NewsEnteroBiotix appoints former GSK Chief Medical Officer to Board
EnteroBiotix has appointed Dr Murray Stewart, former Chief Medical Officer at GSK, to its Board of Directors as the company advances its Phase 2b programme for irritable bowel syndrome with constipation (IBS-C).
NewsAnthropic acquires biotech startup exploring AI-led drug development
Anthropic has acquired Mithril Medicine, a biotech startup that used its Claude AI models to coordinate an experimental drug development programme for muscular dystrophy.
NewsUK clinical trial reforms deliver seven-day approval for eligible trial modifications
Six months after the UK’s revised clinical trials regulations came into force, the Medicines and Healthcare products Regulatory Agency (MHRA) has reported an average seven-day approval timeline for eligible substantial trial modifications under its Route B pathway.
From our partners
Large-scale AAV manufacturing for non-rare diseases
As AAV therapies move beyond rare disease indications, manufacturing scalability becomes critical. Learn how an integrated approach to process development can help reduce risk, improve yields, and prepare for commercial success.
Pharma Horizons: Formulation
Discover the key technologies, risk mitigation strategies and development considerations shaping modern pharmaceutical formulation — from early-stage selection through to commercial-scale manufacturing.
Opinion and interviews
Manufacturing the route: oral and injectable drug delivery
Jennifer Gattari of Pfizer CentreOne discusses how patient needs, evolving delivery formats and emerging manufacturing trends are shaping the pharmaceutical industry, from oral solid dose products to sterile injectables.
How can we ensure consistency in decentralised cell therapy manufacturing?
Following her presentation at Advanced Therapies Europe, Charlotte Serra navigates the complexities of decentralised cell therapy manufacturing.
- Previous
- Next
Join now
Unlock exclusive industry insights
- Bookmark articles and resources to access anytime
- Enjoy free access to industry leading resources, webinars and insights
- Stay informed with the latest news and breakthroughs in drug discovery
- Receive updates and recommendations tailored to your research interests
Upcoming Webinars
Webinar
The impact of negative control stability on recombinant endotoxin testing
Discover how to achieve stable negative control (NC) performance for sensitive and precise recombinant endotoxin testing.
Webinar
Building quality and consistency into accelerated cell and gene therapy development
How can cell and gene therapy manufacturers move programmes forward faster without compromising quality, scalability or regulatory readiness?
The impact of negative control stability on recombinant endotoxin testing
Building quality and consistency into accelerated cell and gene therapy development
On-demand Webinars
- Previous
- Next
