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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
NewsHUTCHMED’s combination therapy improves survival in Phase III NSCLC trial
HUTCHMED’s Phase III SAFFRON trial found that savolitinib plus osimertinib significantly improved progression-free and overall survival in patients with MET-driven, EGFR-mutated non-small cell lung cancer (NSCLC) following progression on osimertinib.
NewsBoehringer and Microsoft joint venture targets digital twins for clinical development
Collaboration will implement modelling and evidence generation to evaluate the use of artificial intelligence (AI) in clinical development and accelerate medicine access.
NewsSundance’s oral TYK2 inhibitor illustrates early promise in multiple sclerosis
Ability to nearly completely inhibit TYK2 pathway biomarkers positions SUN-627 as potential novel treatment for progressive forms of multiple sclerosis, according to Phase I data.
NewsFDA approves novel self-administered autoinjector for generalised myasthenia gravis
US approval of UCB’s Zilbrysq provides a second self-administration option for AChR antibody-positive patients with the rare disease.
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.
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.
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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.
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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
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