Crystal Structures of PF-06438179/GP1111, an Infliximab Biosimilar.

ABSTRACT:

Background

Higher-order structure (HOS) assessment is an important component of biosimilarity evaluations. While established spectroscopic methods are routinely used to characterize structure and evaluate similarity, the addition of X-ray crystallographic analysis to these biophysical methods enables orthogonal elucidation of HOS at higher resolution.

Methods

Crystal structures of the infliximab biosimilar PF-06438179/GP1111 and the reference product Remicade^®, sourced from US and European Union markets, were determined and compared to evaluate HOS similarity. Analytical ultracentrifugation studies were conducted to understand reversible self-association.

Results

In contrast to more routine spectroscopic methods, the crystal structures enable three-dimensio

SUBMITTER: Lerch TF 

PROVIDER: S-EPMC6985046 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature