Analytical Similarity Assessment of ABP 959 in Comparison with Eculizumab Reference Product.
Journal
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy
ISSN: 1179-190X
Titre abrégé: BioDrugs
Pays: New Zealand
ID NLM: 9705305
Informations de publication
Date de publication:
Sep 2021
Sep 2021
Historique:
accepted:
20
06
2021
pubmed:
24
7
2021
medline:
13
10
2021
entrez:
23
7
2021
Statut:
ppublish
Résumé
ABP 959 is one of the first proposed biosimilars to eculizumab reference product (RP), a recombinant IgG2/4 The objective of this work was to comparatively assess analytical (structural and functional) similarity between ABP 959 and eculizumab RP using sensitive, state-of-the art analytical methods capable of detecting minor differences in product quality attributes. Comprehensive analytical (structural and functional) characterization utilizing orthogonal techniques was performed using multiple lots of ABP 959 and eculizumab RP over several years applying > 40 state-of-the-art assays. Comparisons were performed to investigate the primary structure and post-translational modifications including glycans, higher-order structure, particles and aggregates, product-related structures and impurities, thermal stability and forced degradation, general properties, and biological properties mediated by target binding. Results confirmed that ABP 959 had the same amino acid sequence, similar primary structure, higher-order structure, post-translational profiles, and the same protein content and concentration (e.g., ABP 959: 9.4-10.0; eculizumab EU: 9.4-10.0; eculizumab US: 9.3-10.3 mg/mL) as well as biological activity as eculizumab RP. Based on these results, it can be concluded that ABP 959 is analytically similar to eculizumab RP.
Sections du résumé
BACKGROUND
BACKGROUND
ABP 959 is one of the first proposed biosimilars to eculizumab reference product (RP), a recombinant IgG2/4
OBJECTIVES
OBJECTIVE
The objective of this work was to comparatively assess analytical (structural and functional) similarity between ABP 959 and eculizumab RP using sensitive, state-of-the art analytical methods capable of detecting minor differences in product quality attributes.
METHODS
METHODS
Comprehensive analytical (structural and functional) characterization utilizing orthogonal techniques was performed using multiple lots of ABP 959 and eculizumab RP over several years applying > 40 state-of-the-art assays. Comparisons were performed to investigate the primary structure and post-translational modifications including glycans, higher-order structure, particles and aggregates, product-related structures and impurities, thermal stability and forced degradation, general properties, and biological properties mediated by target binding.
RESULTS
RESULTS
Results confirmed that ABP 959 had the same amino acid sequence, similar primary structure, higher-order structure, post-translational profiles, and the same protein content and concentration (e.g., ABP 959: 9.4-10.0; eculizumab EU: 9.4-10.0; eculizumab US: 9.3-10.3 mg/mL) as well as biological activity as eculizumab RP.
CONCLUSIONS
CONCLUSIONS
Based on these results, it can be concluded that ABP 959 is analytically similar to eculizumab RP.
Identifiants
pubmed: 34296421
doi: 10.1007/s40259-021-00492-9
pii: 10.1007/s40259-021-00492-9
pmc: PMC8502742
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Biosimilar Pharmaceuticals
0
Complement C5
0
eculizumab
A3ULP0F556
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
563-577Informations de copyright
© 2021. The Author(s).
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