Today, CD BioGlyco introduced its groundbreaking Antibody Glycoengineering Platform. Addressing diminishing efficiency and a lack of uniformity in therapeutic antibodies, this platform achieves unprecedented control over therapeutic monoclonal antibody glycosylation profiles. To learn more, check out the Antibody Glycoengineering service page.

Monoclonal antibodies (mAbs) represent one of the largest and fastest-growing segments of the biopharmaceutical market, which was valued at over USD 250 billion in 2024 and is projected to continue expanding at a double-digit CAGR. Glycosylation in therapeutic monoclonal antibodies significantly impacts their clinical safety and efficacy. Due to manufacturing-induced variability and the heterogeneous nature of the glycosylation process, it becomes very difficult to create completely homogeneous glycoforms. An acute need for advanced engineering solutions exists to overcome this variability.

The new CD BioGlyco platform uses chemoenzymatic technology to produce monoclonal antibodies with uniform Fc glycoforms. This technology shows vast improvements in the safety and efficacy of monoclonal antibodies, as well as reductions in manufacturing costs, and continuous improvements in their uniformity and consistency. This comprehensive service offers project design and consultation as well as final analysis. The core offerings of the service include antibody remodeling to achieve specific glycoforms (G0, G1, G2, G2S2), antibody digestion (to generate F(ab')₂ and Fab fragments), deglycosylation to enable conjugation, site-specific payload conjugation (e.g., Alexa Fluor dyes, biotin, DFO, azide) for homogeneous ADCs, and antibody cleavage, supporting glycosylation site-specific ADC development. Thorough platform characterization is performed via MALDI-TOF MS, LC-MS/MS, and HILIC-HPLC analysis.

The platform efficiently removes core fucose and converts glycans into target A2G2 glycan structures, thereby converting heterogeneous antibodies into more potent and uniform therapeutics with improved ADCC activity.

Publications in Antibodies have shown that the combination of several engineered modifications in the Fc region, combined with designed sugars (glyco-engineering), considerably enhances the activity of CD19 antibodies in both complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC) pathways. As stated earlier, this technology can be applied to autoimmune diseases, to better control and optimize the pharmacokinetics of biologics, and to produce high-quality biosimilars.

The optimization and shortening of the workflow contribute to the effectiveness and prompt execution of our projects. Our comprehensive MS and chromatographic analyses guarantee quality and purity of our products. CD BioGlyco understands that each project is unique and provides customized solutions to meet the specific needs of our clients.

About CD BioGlyco

CD BioGlyco provides innovative products and high-quality services in the field of glycobiology and antibody therapeutics. Our leading position in the market is attributed to the advanced technology platforms and PhD-trained personnel we have.

Reference
Roßkopf, S., et al. (2020). Enhancing CDC and ADCC of CD19 antibodies by combining Fc protein-engineering with Fc glyco-engineering. Antibodies, 9(4), 63.