A Comparison Between Emerging and Current Biophysical Methods for the Assessment of Higher-Order Structure of Biopharmaceuticals.

Antibodies, Monoclonal / chemistry Biopharmaceutics / instrumentation Biophysics / instrumentation Circular Dichroism / methods Immunoglobulin G / chemistry Nuclear Magnetic Resonance, Biomolecular / methods Protein Stability Protein Structure, Secondary Protein Structure, Tertiary Sensitivity and Specificity Spectrometry, Fluorescence / methods Spectroscopy, Fourier Transform Infrared / methods
biopharmaceutical characterization biophysical methods biosimilarity comparability higher-order structure monoclonal antibody protein structure secondary structure tertiary structure

Journal

Journal of pharmaceutical sciences
ISSN: 1520-6017
Titre abrégé: J Pharm Sci
Pays: United States
ID NLM: 2985195R

Informations de publication

Date de publication:
01 2020
Historique:
received: 08 08 2019
revised: 14 10 2019
accepted: 15 10 2019
pubmed: 2 11 2019
medline: 23 3 2021
entrez: 1 11 2019
Statut: ppublish

Résumé

The higher-order structure (HOS) of protein therapeutics is a critical quality attribute directly related to their function. Traditionally, the HOS of protein therapeutics has been characterized by methods with low to medium structural resolution such as Fourier-transform infrared (FTIR), circular dichroism (CD), and intrinsic fluorescence spectroscopy, and differential scanning calorimetry (DSC). Recently, high-resolution nuclear magnetic resonance (NMR) methods have emerged as powerful tools for HOS characterization. NMR is a multi-attribute method with unique capabilities to provide information about all the structural levels of proteins in solution. We have in this study compared 1 D

Identifiants

DOI: 10.1016/j.xphs.2019.10.026 PMID: 31669605
pubmed: 31669605
pii: S0022-3549(19)30663-X
doi: 10.1016/j.xphs.2019.10.026
pii:
doi:

Substances chimiques

Antibodies, Monoclonal 0
Immunoglobulin G 0

Types de publication

Comparative Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

247-253

Informations de copyright

Copyright © 2020 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Auteurs

Jie Wen (J)

Amgen Inc., Higher Order Structure, Attribute Sciences, Thousand Oaks, California 91320. Electronic address: authorsjwen@amgen.com.

Dipanwita Batabyal (D)

Amgen Inc., Higher Order Structure, Attribute Sciences, Thousand Oaks, California 91320.

Nicholas Knutson (N)

Amgen Inc., Higher Order Structure, Attribute Sciences, Thousand Oaks, California 91320.

Harrison Lord (H)

Amgen Inc., Higher Order Structure, Attribute Sciences, Thousand Oaks, California 91320.

Mats Wikström (M)

Amgen Inc., Higher Order Structure, Attribute Sciences, Thousand Oaks, California 91320. Electronic address: matsw@amgen.com.

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Classifications MeSH

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questionsmedicales.fr › Professions de santé › Pharmacologie › Biopharmacie › A Comparison Between Emerging and Current...
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