Posts about
Analytical Development
News: Alcami St. Louis Facility Issued European Medicines Agency Certification
Alcami’s St. Louis, Missouri Center of Excellence for advanced analytical testing was issued a...
White Paper: Structural Characterization of Biologics Using High-Resolution Mass Spectrometry
Biopharmaceutical products represent up to 20 percent of the total pharmaceutical market and are...
Understanding Biologics: Your Top 7 Questions Answered
The biologics market represents the leading edge of novel therapeutics and is the fastest growing...
Video: Extractables and Leachables
Over the years, the US Pharmacopeia (USP), International Harmonisation (ICH), Product Quality...
eBook: Elemental Impurities
The US Pharmacopeia (USP) retired the existing wet chemistry heavy metals methods outlined in USP...
The Top 5 Most Asked Extractables & Leachables Questions Answered
Agency expectations are quickly evolving for the evaluation of drug product packaging and delivery...
Blog: Agency-Accepted Testing and Filing Strategy for Elemental Impurities
The new elemental impurities regulations stress the importance of controlling all sources of ...
Case Study: Medicines Development for Global Health
In 2016, the not-for-profit Australian biopharmaceutical company Medicines Development for Global...