Anaphylaxis and the inclusion of polysorbates in biotherapeutics
Both unwanted immunogenicity and anaphylaxis comprise major components of safety assessment, however, few if any attempts are made to differentiate drug-related from excipient-related anaphylaxis. Replacement of anaphylactogenic and immunogenic functional excipients with equally effective but safer...
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| Format: | Article |
| Language: | English |
| Published: |
International Pharmaceutical Excipients Council
2017-12-01
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| Series: | Journal of Excipients and Food Chemicals |
| Online Access: | https://jefc.scholasticahq.com/article/3115-anaphylaxis-and-the-inclusion-of-polysorbates-in-biotherapeutics |
| _version_ | 1827312711919206400 |
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| author | Edward Maggio |
| author_facet | Edward Maggio |
| author_sort | Edward Maggio |
| collection | DOAJ |
| description | Both unwanted immunogenicity and anaphylaxis comprise major components of safety assessment, however, few if any attempts are made to differentiate drug-related from excipient-related anaphylaxis. Replacement of anaphylactogenic and immunogenic functional excipients with equally effective but safer alternatives will allow biotherapeutic developers to differentiate their biotherapeutic, biosimilar, or biobetter product from the large number of nearly identical competitor products, simultaneously providing a substantial commercial benefit as well as critical clinical benefits for all concerned - patients, physicians, and third party payers. |
| first_indexed | 2024-04-24T21:48:57Z |
| format | Article |
| id | doaj.art-62e4b54a79a84c13b77a707c7164bef5 |
| institution | Directory Open Access Journal |
| issn | 2150-2668 |
| language | English |
| last_indexed | 2024-04-24T21:48:57Z |
| publishDate | 2017-12-01 |
| publisher | International Pharmaceutical Excipients Council |
| record_format | Article |
| series | Journal of Excipients and Food Chemicals |
| spelling | doaj.art-62e4b54a79a84c13b77a707c7164bef52024-03-20T18:01:32ZengInternational Pharmaceutical Excipients CouncilJournal of Excipients and Food Chemicals2150-26682017-12-0184Anaphylaxis and the inclusion of polysorbates in biotherapeuticsEdward MaggioBoth unwanted immunogenicity and anaphylaxis comprise major components of safety assessment, however, few if any attempts are made to differentiate drug-related from excipient-related anaphylaxis. Replacement of anaphylactogenic and immunogenic functional excipients with equally effective but safer alternatives will allow biotherapeutic developers to differentiate their biotherapeutic, biosimilar, or biobetter product from the large number of nearly identical competitor products, simultaneously providing a substantial commercial benefit as well as critical clinical benefits for all concerned - patients, physicians, and third party payers.https://jefc.scholasticahq.com/article/3115-anaphylaxis-and-the-inclusion-of-polysorbates-in-biotherapeutics |
| spellingShingle | Edward Maggio Anaphylaxis and the inclusion of polysorbates in biotherapeutics Journal of Excipients and Food Chemicals |
| title | Anaphylaxis and the inclusion of polysorbates in biotherapeutics |
| title_full | Anaphylaxis and the inclusion of polysorbates in biotherapeutics |
| title_fullStr | Anaphylaxis and the inclusion of polysorbates in biotherapeutics |
| title_full_unstemmed | Anaphylaxis and the inclusion of polysorbates in biotherapeutics |
| title_short | Anaphylaxis and the inclusion of polysorbates in biotherapeutics |
| title_sort | anaphylaxis and the inclusion of polysorbates in biotherapeutics |
| url | https://jefc.scholasticahq.com/article/3115-anaphylaxis-and-the-inclusion-of-polysorbates-in-biotherapeutics |
| work_keys_str_mv | AT edwardmaggio anaphylaxisandtheinclusionofpolysorbatesinbiotherapeutics |