Microfluidic capillary electrophoresis - mass spectrometry for rapid charge-variant and glycoform assessment of monoclonal antibody biosimilar candidates

Author:

Cageling Ruben,Carillo Sara,Boumeester Anja J.,Lubbers-Geuijen Karin,Bones Jonathan,Jooß Kevin,Somsen Govert W.

Publisher

Elsevier BV

Reference35 articles.

1. D. Bottom, C. Davies, Biosimilars to continue rapid growth over the next decade, 2022. 〈https://www.iqvia.com/blogs/2021/12/biosimilars-to-continue-rapid-growth-over-the-next-decade〉 (accessed October 12, 2023).

2. Analytical similarity assessment of biosimilars: global regulatory landscape, recent studies and major advancements in orthogonal platforms;Nupur;Front. Bioeng. Biotechnol.,2022

3. Biosimilars: review of regulatory, manufacturing, analytical aspects and beyond;Ratih;Microchem. J.,2021

4. Considerations of critical quality attributes in the analytical comparability assessment of biosimilar products;Kwon;Biologicals,2017

5. European Medicines Agency, Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1), EMA/CHMP/BWP/247713/2012, 2012. 〈https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-0.pdf〉 (accessed November 15, 2023).

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