Ira S. Krull | Authors

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.

Glycosylation of monoclonal antibody (mAb) therapeutics is widely recognized by the regulators and the industry as a critical quality attribute (CQA). Hence, it is necessary that glycosylation is measured and adequately controlled during production. This installment reviews the various process parameters and raw material attributes that affect glycosylation, as well as the different analytical tools that are used for characterization, with greater emphasis on the chromatographic methods of analysis. Key recent advancements that have occurred in the past five years are also discussed briefly. While significant progress has been made in the monitoring of glycosylation, its real time control has yet to be demonstrated.

Various analytical approaches and instrumentation for low?molecular-weight (MW), noncovalent, aggregates of proteins are discussed.

In this article, we discuss the role of the gradient in protein separations by reversed-phase and ionexchange high performance liquid chromatography (HPLC).

Second column in a series that reviews impurity method validation guidelines.

This column is the first installment in a two-part series reviewing ICH and FDA impurity method validation guidelines.