Comprehensive analytical characterization of the proposed biosimilar trastuzumab
By: Dakshinamurthy, Pravin Kumar
.
Contributor(s): Gothandam, Kodiveri Muthukaliannan.
Publisher: Karnataka Association of Pharmaceutical Teachers of India (APTI) 2022Edition: Vol.56(2), Apr-June.Description: 438-447p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
Indian journal of pharmaceutical education and researchSummary: Background: Biosimilars to monoclonal antibodies were developed to increase the
accessibility of this drug and reduce the costs of this therapy without compromising on its
quality, safety, and efficacy. The objective of this research is to describe the orthogonal
analytical methods used for the physicochemical and biological characterization of the
biosimilar proposed to trastuzumab, which is the basis of the biosimilar development
program. Methods: The orthogonal analytical methods for characterization of the
proposed biosimilar to trastuzumab were segregated based on the quality attributes
of the product, such as the primary structure was evaluated using peptide mapping
and high-end mass spectrometry, secondary and tertiary structure was evaluated
using circular dichroism, fluorescence, and absorbance spectroscopy, identity and size
heterogeneity were evaluated using Western blotting, size exclusion chromatography and
capillary electrophoresis, charge heterogeneity, glycan heterogeneity and hydrophobic
heterogeneity were evaluated using by weak cation exchange liquid chromatography,
hydrophilic interaction chromatography and reverse phase liquid chromatography, antigen
binding and Fc gamma receptor binding was evaluated using surface plasmon resonance,
flow cytometry and cell-based enzyme linked immunosorbent assay, antiproliferation and
antibody dependent cellular cytotoxicity were evaluated using
in vitro cell-based bioassay.
Results and Conclusion: The results of a comprehensive analytical characterization of
the proposed biosimilar to the innovator trastuzumab confirm that the physicochemical
and biological properties of the proposed biosimilar were comparable to those of the
innovator molecule trastuzumab.
| Item type | Current location | Call number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|
Articles Abstract Database
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School of Pharmacy Archieval Section | Not for loan | 2022-1428 |
Background: Biosimilars to monoclonal antibodies were developed to increase the
accessibility of this drug and reduce the costs of this therapy without compromising on its
quality, safety, and efficacy. The objective of this research is to describe the orthogonal
analytical methods used for the physicochemical and biological characterization of the
biosimilar proposed to trastuzumab, which is the basis of the biosimilar development
program. Methods: The orthogonal analytical methods for characterization of the
proposed biosimilar to trastuzumab were segregated based on the quality attributes
of the product, such as the primary structure was evaluated using peptide mapping
and high-end mass spectrometry, secondary and tertiary structure was evaluated
using circular dichroism, fluorescence, and absorbance spectroscopy, identity and size
heterogeneity were evaluated using Western blotting, size exclusion chromatography and
capillary electrophoresis, charge heterogeneity, glycan heterogeneity and hydrophobic
heterogeneity were evaluated using by weak cation exchange liquid chromatography,
hydrophilic interaction chromatography and reverse phase liquid chromatography, antigen
binding and Fc gamma receptor binding was evaluated using surface plasmon resonance,
flow cytometry and cell-based enzyme linked immunosorbent assay, antiproliferation and
antibody dependent cellular cytotoxicity were evaluated using
in vitro cell-based bioassay.
Results and Conclusion: The results of a comprehensive analytical characterization of
the proposed biosimilar to the innovator trastuzumab confirm that the physicochemical
and biological properties of the proposed biosimilar were comparable to those of the
innovator molecule trastuzumab.
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