title: Host Cell Proteins: The Hidden Side of Biosimilarity Assessment.
abstract: One major concern with biosimilars is that small differences compared with reference products might lead to unforeseen immunogenicity, thus affecting patient safety and drug efficacy. Differences could be due to either post-translational modifications of the therapeutic protein and/or to traces of impurities from the manufacturing process. The results presented in this communication illustrate the efforts to assess "biosimilarity" of a biosimilar candidate to a reference product for a specific group of process-related impurities, the host cell proteins (HCP). Extensive characterization of HCP in the drug substance of a biosimilar candidate revealed the identity of HCP copurifying with the protein of interest and guided process development to improve overall HCP clearance in the downstream process. The data presented illustrate the challenge of matching the reference product on either quantitative or qualitative aspects of HCP impurities.
authors.affiliation: Research Institute, JCR Pharmaceuticals Co., Ltd., Kobe 651-2241, Japan.
authors.forename: Kazutoshi
authors.initials: K
authors.lastname: Mihara
authors.affiliation: Research Institute, JCR Pharmaceuticals Co., Ltd., Kobe 651-2241, Japan.
authors.forename: Yae
authors.initials: Y
authors.lastname: Ito
authors.affiliation: Research Institute, JCR Pharmaceuticals Co., Ltd., Kobe 651-2241, Japan.
authors.forename: Yukichi
authors.initials: Y
authors.lastname: Hatano
authors.affiliation: Research Institute, JCR Pharmaceuticals Co., Ltd., Kobe 651-2241, Japan.
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Komurasaki
authors.affiliation: Research Institute, JCR Pharmaceuticals Co., Ltd., Kobe 651-2241, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Sugimura
authors.affiliation: R&D Platform Technology and Science, GlaxoSmithKline, King of Prussia, Pennsylvania 19406.
authors.forename: Marisa
authors.initials: M
authors.lastname: Jones
authors.affiliation: R&D Platform Technology and Science, GlaxoSmithKline, King of Prussia, Pennsylvania 19406.
authors.forename: Haiyan
authors.initials: H
authors.lastname: Liu
authors.affiliation: R&D Platform Technology and Science, GlaxoSmithKline, King of Prussia, Pennsylvania 19406.
authors.forename: Shing
authors.initials: S
authors.lastname: Mai
authors.affiliation: R&D Platform Technology and Science, GlaxoSmithKline, King of Prussia, Pennsylvania 19406.
authors.forename: Oscar
authors.initials: O
authors.lastname: Lara-Velasco
authors.affiliation: R&D Platform Technology and Science, GlaxoSmithKline, King of Prussia, Pennsylvania 19406.
authors.forename: Lin
authors.initials: L
authors.lastname: Bai
authors.affiliation: R&D Platform Technology and Science, GlaxoSmithKline, King of Prussia, Pennsylvania 19406.
authors.forename: Amol
authors.initials: A
authors.lastname: Ketkar
authors.affiliation: R&D Platform Technology and Science, GlaxoSmithKline, Stevenage, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Adams
authors.affiliation: Research Institute, JCR Pharmaceuticals Co., Ltd., Kobe 651-2241, Japan. Electronic address: hirato-t@jcrpharm.co.jp.
authors.forename: Tohru
authors.initials: T
authors.lastname: Hirato
authors.affiliation: R&D Platform Technology and Science, GlaxoSmithKline, King of Prussia, Pennsylvania 19406. Electronic address: roxana.m.butoi@gsk.com.
authors.forename: Roxana
authors.initials: R
authors.lastname: Ionescu
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000737:chemistry*; D001709:Biotechnology / Q000379:methods; D011499:Protein Processing, Post-Translational / Q000187:drug effects; D011506:Proteins / Q000737:chemistry*
chemical_list: D059451:Biosimilar Pharmaceuticals; D011506:Proteins
keywords: ELISA; PLBL2; analytical biochemistry; biosimilar; biotechnology; cell culture; comparability; glycoprotein; host cell proteins; immunology