Analytical and bioanalysis
Explore analytical and bioanalytical technologies supporting pharmaceutical development and manufacturing, including chromatography, mass spectrometry, spectroscopy, bioassays, method validation, impurity testing and sample preparation to ensure product quality, safety and regulatory compliance.
Latest in analytical and bioanalysis
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Strategies for scaling complex next-generation biologics
As biologic drug formats grow more sophisticated, scalable success depends on embedding manufacturability, analytics and quality thinking into molecular design from the very beginning of development.
Article
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.
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The impact of negative control stability on recombinant endotoxin testing
Discover how PYROSTARâ„¢ Neo+ supports stable negative control (NC) performance for sensitive and precise recombinant endotoxin testing.
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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Reports and whitepapers in analytical and bioanalysis
Pharma Horizons: Nitrosamines
EPR’s 2026 nitrosamines report covers the key developments in manufacturing, quality, regulation, analytical development and beyond.
Articles in analytical and bioanalysis
Article
Strategies for scaling complex next-generation biologics
As biologic drug formats grow more sophisticated, scalable success depends on embedding manufacturability, analytics and quality thinking into molecular design from the very beginning of development.
Article
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.
