Analytics Archives

The Introduction of Digital Reference Standards in the Pharmaceutical Industry

By Joseph Posada Apr 13, 2026 Analytics Compliance Reference Standards

While perusing the current USP <11>, USP Reference Standards, which became effective on December 1, 2025, it was noted that the USP Reference Standard description was amended to state “highly characterized physical materials or digital data demonstrated to have the appropriate qualities to support their intended use as references for comparison in compendial tests.” The General Chapter […]

Feb

Comparative Analytical Assessment of Biological Therapeutic Proteins

By Paul Mason, PhD. Feb 05, 2026 Analytics Biologics Biosimilars

The FDA issued a guidance document “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations” (September 2025) (here) that focusses on the analytical approaches to be employed for comparative testing to demonstrate similarity between the proposed recombinant protein product and the reference (recognizing that the tools within the guidance could be applied […]