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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...