Analytical and Functional Similarity Assessment of ABP 710, a Biosimilar to Infliximab Reference Product.

ABSTRACT:

Purpose

ABP 710 has been developed as a biosimilar to infliximab reference product (RP). The objective of this study was to assess analytical similarity (structural and functional) between ABP 710 and infliximab RP licensed by the United States Food and Drug Administration (infliximab [US]) and the European Union (infliximab [EU]), using sensitive, state-of-the-art analytical methods capable of detecting minor differences in product quality attributes.

Methods

Comprehensive analytical characterization utilizing orthogonal techniques was performed with 14 to 28 unique lots of ABP 710 or infliximab RP, depending on the assay. Comparisons were used to investigate the primary structure related to amino acid sequence; post-translational modifications (PTMs) including glycans; hig

SUBMITTER: Saleem R 

PROVIDER: S-EPMC7261735 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature