Analytical Platform for Monitoring Aggregation of Monoclonal Antibody Therapeutics

Purpose To develop an analytical platform for the estimation as well as characterization of aggregates over the complete size spectrum (from invisible monomer to visible precipitates). Methods Two mAb samples were incubated at 30°C in different buffer systems of protein A chromatography for observin...

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Bibliographic Details
Published in:Pharmaceutical research 2019-11, Vol.36 (11), p.152-11, Article 152
Main Authors: Bansal, Rohit, Gupta, Surbhi, Rathore, Anurag S.
Format: Article
Language:English
Subjects:
Biochemistry
Biomedical and Life Sciences
Biomedical Engineering and Bioengineering
Biomedicine
Chromatography
Ions
Light scattering
Medical Law
Monoclonal antibodies
Pharmacology/Toxicology
Pharmacy
Photon correlation spectroscopy
Precipitates
Protein A
Research Paper
Size exclusion chromatography
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Summary:Purpose To develop an analytical platform for the estimation as well as characterization of aggregates over the complete size spectrum (from invisible monomer to visible precipitates). Methods Two mAb samples were incubated at 30°C in different buffer systems of protein A chromatography for observing degradation due to aggregation. The aggregation in these samples was quantified by size exclusion chromatography (SEC), dynamic light scattering (DLS), and micro flow imaging (MFI). Results The results obtained from various characterization tools were analysed in various size ranges - size exclusion chromatography (SEC) (1 nm - 25 nm), dynamic light scattering (DLS) (10 nm - 5 μm), and micro flow imaging (MFI) (2 μm - 300 μm). Since each characterization tool covers a particular size range, data from multiple tools was collected in the “handover” regions to demonstrate accuracy of the platform. Conclusions Based on the observations from the experiments, an analytical platform has been proposed covering the whole size spectrum that would be of utility to those engaged in formulation development as well as other aspects related to stability of biotherapeutic products.
ISSN:0724-8741
1573-904X
DOI:10.1007/s11095-019-2690-8