In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...
DS InPharmatics Head of Analytical Services, Colman Byrne joins the show to share his experience in analytical method development and validation. Colman is the most senior analytical services expert ...
This field has evolved considerably through the integration of systematic design strategies, notably the incorporation of Analytical Quality by Design (AQbD) principles and robust statistical tools ...
Good HPLC methods must satisfy both technical requirements (sensitivity, specificity, linearity, accuracy and precision) as well as business needs (reliability in routine use and a run time ...
Aseptic processing demands reliable, robust, and validated analytical methods to ensure sterility, safety, and quality, ...
BOCA RATON, Fla.--(BUSINESS WIRE)--LGM Pharma today announced the launch of its new Analytical Services offering that provides analytical testing and stability services to pharmaceutical developers ...
BOCA RATON, Fla.--(BUSINESS WIRE)--LGM Pharma, a leading provider of tailored API and CDMO services for the full drug product lifecycle, today announced a significant enhancement of its capabilities: ...
Sherry Gu, Executive Vice President and CTO at WuXi Biologics, explains the critical challenges of developing bispecific ...
LCGC International spoke with Dave Bell about the key developments he expects to influence chromatography in 2026. Drawing on ...
Since 2007, guidelines from the European Medicines Agency and a draft version from the U.S. Food & Drug Administration have called on the drug industry to reduce DNA-reactive genotoxic impurities ...
Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability ...