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 ...
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: ...
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 ...
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 ...
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 ...
Monique Paré Speirs is a researcher and method developer for Rhyz Analytical Labs (a Nu Skin company), a QC testing lab for raw materials, dietary supplements, cosmetics, and personal care products.
Aseptic processing demands reliable, robust, and validated analytical methods to ensure sterility, safety, and quality, ...
The CPCA provides a simplified molecular structural assessment for nitrosamines, aiding in safety evaluations when limited data is available. Determining acceptable intake limits for nitrosamines is ...
Sherry Gu, Executive Vice President and CTO at WuXi Biologics, explains the critical challenges of developing bispecific ...