CD BioGlyco can customize one-stop services for glycoengineered antibodies according to customers' R&D or cGMP production needs. We have confidence to be your essential research assistant in the field of glycobiology. 

Glycoengineering in Antibodies

Monoclonal antibodies (mAbs) are currently the largest and fastest-growing category of biopharmaceuticals. Since 1984, more than 60 mAbs and fusion molecules has been approvedfor use in more than 30 cancers, autoimmune and cardiovascular diseases. It is estimated that by 2024, the global market value of mAbs will reach 138.6 billion dollars.

The clinical efficacy and safety of mAbs are affected by their glycosylation structure and composition. Glycosyl distribution is usually heterogeneous, depends largely on the manufacturing process, and is therefore susceptible to changes in cell culture conditions. Therefore, it is considered a key quality attribute of mAbs. Great efforts have been made in mammalian and non-mammalian cells to control the glycosylation of mAbs. However, it is still a challenge to obtain a specific glycoform that is completely homogeneous.

The latest innovations in chemoenzymatic glycoengineering technology will allow the production of mAbs with well-defined and uniform Fc glycoforms, thereby giving them the desired biological properties. This method has significant advantages, such as enhanced Fc effector function, improved safety, higher batch-to-batch consistency, reduced immunogenicity, and can be expressed economically. Overall, producing mAbs with the innovative glycoengineering technology will bring tangible benefits to patients and manufacturers.

Fig.1 Glycoengineering of therapeutic antibodies. (Li, et al., 2021)

Key Technologies

Mammalian host systems are the preferred expression platform because they can maximize the post-translational processing and functional activity of proteins.

• CD BioGlyco provides the most prominent host cell lines for commercially available products: Chinese Hamster Ovary (CHO) or Mouse Myeloma (NS0, SP2/0) cell lines, and other cell lines. We have carried out glycoengineering of different cell lines, and strictly controlled and optimized environmental factors and cell culture conditions.

Chemoenzymatic glycoengineering refers to the in vitro remodeling of glycans using enzymes such as endoglycosidase and sugar synthase.

• The solution we provide usually includes three steps: Deglycosylation of IgG by endo β-N-acetylglucosaminidase (ENGase, such as Endo S), while retaining the innermost GlcNAc at N297; the oxazoline derivatives with customized N-linked glycan structure as sugar donors are prepared by chemical methods; transglycosylation of the glycan oxazoline donor to the innermost GlcNAc acceptor.

Antibody Glycoengineering: Precision, Potency, and Performance

At CD BioGlyco, our expertise in antibody glycoengineering is built upon a foundation of cutting-edge technologies designed for precision and control. We leverage a suite of advanced methodologies to manipulate antibody glycosylation, ensuring optimal performance for diverse applications. Our services include:

• Project Design

After gaining a deep understanding of your project's unique needs, target antibody characteristics, and desired functional outcomes, our experts will work with you to develop the optimal glycoengineering strategy, taking into account factors such as antibody class, target activity, and desired glycoforms.

• Antibody Expression and Purification

Select the appropriate cell line to express your antibody of interest at high yield and quality. Purify using chromatography to ensure purity and integrity.

• Glycoengineering Modification

This is the core of our service, where precise glycoengineering modifications are performed. Depending on the agreed-upon strategy, this may involve:

• Comprehensive Analysis

We utilize advanced analytical techniques such as Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS), liquid chromatography–tandem MS (LC-MS/MS), and hydrophilic interaction liquid chromatography (HILIC)-HPLC to meticulously characterize the glycan profiles of antibodies, confirm the success of the engineering process, and quantify the desired glycoforms.

Workflow

Publication Data

Applications

• Autoimmune diseases: Engineering antibodies with modified glycan profiles (e.g., increased sialylation) to reduce inflammation and modulate immune responses in conditions like rheumatoid arthritis and lupus.
• Pharmacokinetic optimization: Modifying glycan structures to extend antibody half-life in circulation, reducing dosing frequency, and improving compliance.
• Biosimilar development: Characterizing and matching glycan profiles of innovator biologics to ensure comparability and efficacy of biosimilar products.

Advantages

• Our streamlined workflow and extensive experience allow for rapid project execution, from initial consultation to final product delivery. This efficiency helps accelerate your drug development timelines.
• We provide robust and comprehensive glycan analysis using state-of-the-art MS and chromatographic techniques. This detailed characterization ensures the quality, purity, and precise glycoform composition of every antibody.
• Recognizing that each project is unique, we offer highly flexible and customized glycoengineering strategies tailored to your specific antibody and goals.

Frequently Asked Questions

CD BioGlyco is your trusted partner in advancing biopharmaceutical innovation through precision antibody glycoengineering. From precise glycan remodeling to site-specific conjugation, our comprehensive services are designed to meet the most demanding research and development challenges. Please feel free to contact us; our team of experienced specialists is eager to collaborate with you and provide tailored solutions.

Associated Services