| Autor: |
Lars M H, Reinders, Martin D, Klassen, Thorsten, Teutenberg, Martin, Jaeger, Torsten C, Schmidt |
| Rok vydání: |
2021 |
| Předmět: |
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| Zdroj: |
Analytical and bioanalytical chemistry. 414(23) |
| ISSN: |
1618-2650 |
| Popis: |
Due to the complex manufacturing process of therapeutic monoclonal antibodies, it is hardly possible to produce an identical copy of the original product (originator). Consequently, follow-on products (biosimilars) must demonstrate their efficacy being similar to the originator in terms of structure and function. During this process, a variety of analytical methods are required for this purpose. This study focuses on three particularly relevant analytical techniques: high-resolution mass spectrometry, fragment crystallisable (Fc) affinity chromatography, and two-dimensional peptide mapping. Each analytical method proved able to identify specific differences between originator and biosimilar. High-resolution mass spectrometry was used to characterize the glycan pattern. It was shown that a trastuzumab biosimilar did not have the G0:G0F sugar modification identified in the originator. The application of affinity chromatography to rituximab showed that originator and biosimilar interacted differently with the immobilized Fc receptor. Furthermore, 2D-HPLC peptide mapping demonstrated the influence of orthogonality of separation dimensions, leading to differentiation of a rituximab originator and biosimilar. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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