Comprehensive analytical characterization of the proposed biosimilar trastuzumab (Record no. 17361)
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| 000 -LEADER | |
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| fixed length control field | a |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20220829162433.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 220829b xxu||||| |||| 00| 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | AIKTC-KRRC |
| Transcribing agency | AIKTC-KRRC |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 17659 |
| Author | Dakshinamurthy, Pravin Kumar |
| 245 ## - TITLE STATEMENT | |
| Title | Comprehensive analytical characterization of the proposed biosimilar trastuzumab |
| 250 ## - EDITION STATEMENT | |
| Volume, Issue number | Vol.56(2), Apr-June |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | Karnataka |
| Name of publisher, distributor, etc. | Association of Pharmaceutical Teachers of India (APTI) |
| Year | 2022 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Pagination | 438-447p. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Background: Biosimilars to monoclonal antibodies were developed to increase the<br/>accessibility of this drug and reduce the costs of this therapy without compromising on its<br/>quality, safety, and efficacy. The objective of this research is to describe the orthogonal<br/>analytical methods used for the physicochemical and biological characterization of the<br/>biosimilar proposed to trastuzumab, which is the basis of the biosimilar development<br/>program. Methods: The orthogonal analytical methods for characterization of the<br/>proposed biosimilar to trastuzumab were segregated based on the quality attributes<br/>of the product, such as the primary structure was evaluated using peptide mapping<br/>and high-end mass spectrometry, secondary and tertiary structure was evaluated<br/>using circular dichroism, fluorescence, and absorbance spectroscopy, identity and size<br/>heterogeneity were evaluated using Western blotting, size exclusion chromatography and<br/>capillary electrophoresis, charge heterogeneity, glycan heterogeneity and hydrophobic<br/>heterogeneity were evaluated using by weak cation exchange liquid chromatography,<br/>hydrophilic interaction chromatography and reverse phase liquid chromatography, antigen<br/>binding and Fc gamma receptor binding was evaluated using surface plasmon resonance,<br/>flow cytometry and cell-based enzyme linked immunosorbent assay, antiproliferation and<br/>antibody dependent cellular cytotoxicity were evaluated using<br/>in vitro cell-based bioassay.<br/>Results and Conclusion: The results of a comprehensive analytical characterization of<br/>the proposed biosimilar to the innovator trastuzumab confirm that the physicochemical<br/>and biological properties of the proposed biosimilar were comparable to those of the<br/>innovator molecule trastuzumab. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| 9 (RLIN) | 4639 |
| Topical term or geographic name entry element | PHARMACEUTICS |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 17660 |
| Co-Author | Gothandam, Kodiveri Muthukaliannan |
| 773 0# - HOST ITEM ENTRY | |
| Place, publisher, and date of publication | Bengluru Association of Pharmaceutical Teachers of India (APTI) |
| International Standard Serial Number | 0019-5464 |
| Title | Indian journal of pharmaceutical education and research |
| 856 ## - ELECTRONIC LOCATION AND ACCESS | |
| URL | https://www.ijper.org/sites/default/files/IndJPhaEdRes-56-2-438.pdf |
| Link text | Click here |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Dewey Decimal Classification |
| Koha item type | Articles Abstract Database |
| Withdrawn status | Lost status | Source of classification or shelving scheme | Damaged status | Not for loan | Home library | Current library | Shelving location | Date acquired | Total Checkouts | Barcode | Date last seen | Price effective from | Koha item type |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dewey Decimal Classification | School of Pharmacy | School of Pharmacy | Archieval Section | 29/08/2022 | 2022-1428 | 29/08/2022 | 29/08/2022 | Articles Abstract Database |