What is In Vitro Glycoengineering (IVGE)?
The majority of top-selling biopharmaceuticals are glycoproteins, complex molecules whose properties and functions are significantly influenced by their attached glycans (sugar structures). These glycans play a crucial role in determining the pharmacokinetic and pharmacodynamic properties of the biopharmaceutical, including its stability, half-life, and biological activity.
For monoclonal antibodies (mAbs), which represent a large portion of the biopharmaceutical market, the glycoform profile is considered a critical quality attribute (CQA). This means that the specific pattern and composition of glycans attached to the antibody can directly impact its safety and efficacy. As a result, regulatory agencies require biosimilar developers to closely match the glycoform profile of the originator drug when creating a biosimilar version.
One promising approach is in vitro glycoengineering (IVGE), which involves modifying the glycan structures of purified proteins using specific enzymes and activated sugar substrates. This method offers several advantages:
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Independence from production process: IVGE can be performed after protein purification, allowing glycan modification without altering the upstream manufacturing process.
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Precision: It enables fine-tuning of specific glycan structures to optimize desired properties.
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Flexibility: IVGE can be applied to different protein products and adapted to create various glycoforms.
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Potential for standardization: This approach could help reduce batch-to-batch variability in glycosylation profiles.
By leveraging IVGE and other glycoengineering techniques, biopharmaceutical companies can potentially enhance the efficacy, stability, and manufacturing consistency of their products, while also facilitating the development of biosimilars that more closely match their reference biologics.
What do we offer?
At eversyn, we offer a comprehensive solution for precise control over protein glycosylation. Our product portfolio includes high-quality, cost-effective activated sugars alongside innovative, highly active enzymes such as glycosyltransferases and glycosidases. These cutting-edge tools empower researchers and biopharmaceutical developers to fine-tune glycoprotein structures with unprecedented precision.
Our vision extends beyond providing individual components; we aim to deliver a readily applicable technology that revolutionizes glycoengineering across scales. By offering robust, scalable solutions, we enable seamless glycosylation optimization from small-scale laboratory experiments to technical-scale production. Moreover, we're paving the way for the integration of advanced glycoengineering techniques into large-scale biopharmaceutical manufacturing processes.
Currently available:
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α1,3GalT
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α1,6Fuc
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Sia2,6T
Publications
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Ruhnau, J. et al., 2021. Cell Free Glycoengineering of the Recombinant SARS-CoV-2 Spike Glycoprotein.
https://doi.org/10.3389/fbioe.2021.699025 -
Rexer, TFT. et al., 2020. Enzymatic Synthesis of Glycans and Glycoconjugates.
https://doi.org/10.1007/10_2020_148