AI Article Synopsis
- The manufacturing process for therapeutic monoclonal antibodies is complex, making it difficult to create identical copies (biosimilars) of the original product (originator).
- To ensure biosimilars are similar in efficacy to the originator, various analytical methods are needed, specifically high-resolution mass spectrometry, Fc affinity chromatography, and two-dimensional peptide mapping.
- Each method was effective in identifying differences between originator and biosimilar, such as variations in glycan patterns, interactions with Fc receptors, and separation of peptide components.
Article Abstract
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.
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| http://dx.doi.org/10.1007/s00216-022-04236-8 | DOI Listing |
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