Chromatography Online
CONTINUE TO SITE >

OR WAIT 15 SECS

Diane Wilkinson | Authors

Articles

Agency Guidelines for Recombinant Biosimilars of Biopharmaceuticals

All agencies have issued varying guidances for the approval of recombinant biosimilars of biopharmaceuticals, and all submittals are considered on a case-by-case basis. This instalment of “Focus on Biopharmaceutical Analysis” looks at the best methodologies for demonstrating their analytical comparability.