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.
Discover the key technologies, risk mitigation strategies and development considerations shaping modern pharmaceutical formulation — from early-stage selection through to commercial-scale manufacturing.
EPR Issue 2 includes articles on manufacturing, drug formulation, microbiology, downstream bioprocessing, and more.
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.
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.
US approval of UCB’s Zilbrysq provides a second self-administration option for AChR antibody-positive patients with the rare disease.
Investment involves potential best-in-class therapy from siRNA specialist Silence Therapeutics.
New manufacturing plant set to strengthen supply security for insulin in Europe.
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.
EPR Issue 2 includes articles on manufacturing, drug formulation, microbiology, downstream bioprocessing, and more.
Download this application note to learn how the MAS-100 Libra® supports automated settle plate exposure while maintaining airflow integrity, first-air conditions and effective VHP decontamination in critical aseptic environments.
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.
Following her presentation at Advanced Therapies Europe, Charlotte Serra navigates the complexities of decentralised cell therapy manufacturing.