Analytical techniques for the characterization and quantification of monoclonal antibodies
HA Alhazmi, M Albratty - Pharmaceuticals, 2023 - mdpi.com
Monoclonal antibodies (mAbs) are a fast-growing class of biopharmaceuticals. They are
widely used in the identification and detection of cell makers, serum analytes, and …
widely used in the identification and detection of cell makers, serum analytes, and …
Advancing pharmaceutical quality: An overview of science and research in the US FDA's Office of Pharmaceutical Quality
AC Fisher, SL Lee, DP Harris, L Buhse… - International journal of …, 2016 - Elsevier
Failures surrounding pharmaceutical quality, particularly with respect to product
manufacturing issues and facility remediation, account for the majority of drug shortages and …
manufacturing issues and facility remediation, account for the majority of drug shortages and …
Enabling adoption of 2D-NMR for the higher order structure assessment of monoclonal antibody therapeutics
RG Brinson, JP Marino, F Delaglio, LW Arbogast… - MAbs, 2019 - Taylor & Francis
The increased interest in using monoclonal antibodies (mAbs) as a platform for
biopharmaceuticals has led to the need for new analytical techniques that can precisely …
biopharmaceuticals has led to the need for new analytical techniques that can precisely …
Multivariate Analysis of Two-Dimensional 1H, 13C Methyl NMR Spectra of Monoclonal Antibody Therapeutics To Facilitate Assessment of Higher Order Structure
LW Arbogast, F Delaglio, JE Schiel… - Analytical …, 2017 - ACS Publications
Two-dimensional (2D) 1H–13C methyl NMR provides a powerful tool to probe the higher
order structure (HOS) of monoclonal antibodies (mAbs), since spectra can readily be …
order structure (HOS) of monoclonal antibodies (mAbs), since spectra can readily be …
Recent advancements, challenges, and practical considerations in the mass spectrometry-based analytics of protein biotherapeutics: A viewpoint from the biosimilar …
V Háda, A Bagdi, Z Bihari, SB Timári, Á Fizil… - … of pharmaceutical and …, 2018 - Elsevier
The extensive analytical characterization of protein biotherapeutics, especially of
biosimilars, is a critical part of the product development and registration. High-resolution …
biosimilars, is a critical part of the product development and registration. High-resolution …
Toward reliable lipoprotein particle predictions from NMR spectra of human blood: an interlaboratory ring test
S Monsonis Centelles, HCJ Hoefsloot… - Analytical …, 2017 - ACS Publications
Lipoprotein profiling of human blood by 1H nuclear magnetic resonance (NMR)
spectroscopy is a rapid and promising approach to monitor health and disease states in …
spectroscopy is a rapid and promising approach to monitor health and disease states in …
Epitope mapping and binding assessment by solid-state NMR provide a way for the development of biologics under the quality by design paradigm
D Rizzo, L Cerofolini, S Giuntini, L Iozzino… - Journal of the …, 2022 - ACS Publications
Multispecific biologics are an emerging class of drugs, in which antibodies and/or proteins
designed to bind pharmacological targets are covalently linked or expressed as fusion …
designed to bind pharmacological targets are covalently linked or expressed as fusion …
Characterization of PEGylated Asparaginase: new opportunities from NMR analysis of large PEGylated therapeutics
L Cerofolini, S Giuntini, A Carlon… - … A European Journal, 2019 - Wiley Online Library
Resonance assignment and structural characterization of pharmacologically relevant
proteins promise to improve understanding and safety of these proteins by rational design …
proteins promise to improve understanding and safety of these proteins by rational design …
Biosimilar structural comparability assessment by NMR: from small proteins to monoclonal antibodies
B Japelj, G Ilc, J Marušič, J Senčar, D Kuzman… - Scientific reports, 2016 - nature.com
Biosimilar drug products must have a demonstrated similarity with respect to the reference
product's molecules in order to ensure both the effectiveness of the drug and the patients' …
product's molecules in order to ensure both the effectiveness of the drug and the patients' …
Interlaboratory studies using the NISTmAb to advance biopharmaceutical structural analytics
K Yandrofski, T Mouchahoir, ML De Leoz… - Frontiers in molecular …, 2022 - frontiersin.org
Biopharmaceuticals such as monoclonal antibodies are required to be rigorously
characterized using a wide range of analytical methods. Various material properties must be …
characterized using a wide range of analytical methods. Various material properties must be …