Srishti Joshi

The authors discuss key findings from recent biosimilarity assessments they conducted on biosimilars of granulocyte-colony-stimulating factor (G-CSF), insulin glargine, rituximab, and trastuzumab.

What is the right number of replicates in biopharmaceutical analysis? Does the answer depend on the type of analysis?

Recent assessments of four biosimilars illustrate how a combination of orthogonal, high-resolution tools is used to demonstrate analytical and functional biosimilarity.

The analytical techniques used for characterizing biotherapeutics have evolved. We review the utility of the traditional tools and discuss the new, orthogonal techniques that are increasingly being used.

To ensure the reliable and accurate characterization of biotherapeutics, an arsenal of orthogonal analytical techniques is needed.