Recommendations for the Contents of the “Glycan Profile” Part of a Product Specification File
“Glycan Profile” is a necessary part of manufacturers’ product specification files for monoclonal antibody active ingredients or final products and erythropoietin active ingredients. The expert of the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products”...
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Main Author: | O. A. Vaganova |
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Format: | Article |
Language: | Russian |
Published: |
Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
2021-12-01
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Series: | Регуляторные исследования и экспертиза лекарственных средств |
Subjects: | |
Online Access: | https://www.vedomostincesmp.ru/jour/article/view/413 |
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