Glyco-Engineering-Based Therapeutic Protein Production

Glycosylation is an important process of protein modification, and almost all therapeutic proteins are glycosylated. It has a significant impact on protein stability, activity, and pharmacokinetics. As a trusted protein production contract organization, CD Formulation is committed to applying advanced glycoengineering technology to optimize the glycosylation process of therapeutic proteins, thereby helping customers design and produce therapeutic proteins that meet specific requirements.

Glycosylation & Glyco-Engineering

Glycosylation is the process by which sugars are attached to proteins. In therapeutic proteins, the amount and composition of glycans play an important role in protein folding, solubility, and intracellular trafficking, affecting the biological activity of the therapeutic and the half-life in the blood. In theory, glycans on proteins are very diverse in structure. Due to their importance in therapy, tremendous efforts have been made in recent years to overcome glycosylation heterogeneity and establish in vivo and in vitro glycoengineering technologies to efficiently produce homogeneous therapeutic glycoproteins. Glycoengineering technology involves the deliberate modification of the glycosylation pattern of therapeutic proteins using a range of advanced technologies, including genetic modification of the cell lines used for production, alteration of glycan structure by enzymatic treatment, or the use of cell-free expression systems, to produce a new generation of glycoprotein therapeutics with enhanced biological activity.

Fig. 1 N-glycans influence the clearance of therapeutic proteins. (Dammen-Brower K, et al., 2022)

Explore Our Glyco-Engineering-Based Therapeutic Protein Production Services

CD Formulation is a global leader in glycoengineering, specializing in the production of high-quality therapeutic proteins. Our expertise combined with state-of-the-art facilities enables us to provide comprehensive solutions for a wide range of therapeutic applications. From GMP to non-GMP proteins, we focus on delivering superior results that meet your specific needs.

Importantly, our advanced glycoengineering technologies enable the customization of glycan structures to optimize the performance and safety of therapeutic proteins. By precisely designing and regulating the composition and arrangement of glycans, we are able to enhance the stability, half-life, and biocompatibility of proteins, thereby improving their effectiveness in clinical applications. We ensure that your protein is optimized for its intended therapeutic application.

We provide a one-stop service from cell line selection to scale-up production, including:

Cell Line Development

• Generate mammalian cell lines engineered to produce proteins with desired glycosylation patterns.
• Optimize culture conditions to enhance glycosylation outcomes.

Glycan Profiling

• Comprehensively analyze glycans attached to therapeutic proteins to ensure consistency, safety, and efficacy.
• Mass Spectrometry (MS): Molecular weight analysis, structural elucidation of glycans.
• High-Performance Liquid Chromatography (HPLC): Separation and purification of glycans, quantitative analysis (combined with different detectors, such as differential refractometer, fluorescence detector, etc.).
• Nuclear Magnetic Resonance (NMR): Glycan structure.
• Gas Chromatography (GC): Analysis of volatile or derivatized glycans.

Glycan Modification Services

• Customly modifies glycan structures to potentially improve the pharmacokinetics and pharmacodynamics of therapeutic proteins.
• Use enzymatic or chemical methods that inhibit glycosylation to produce specific glycoforms.

Scaling Up Manufacturing

• Transition from laboratory scale to commercial scale production while maintaining glycoengineered properties.
• Implement process optimization strategies to improve yield and reproducibility.

Product Types That Can be Developed

• Monoclonal Antibodies: Optimizing glycosylation patterns can enhance antibody-dependent cellular cytotoxicity (ADCC) and extend serum half-life, thereby improving therapeutic efficacy in diseases such as cancer and autoimmune diseases.
• Enzymes: Engineering enzymes to improve their stability and activity in therapeutic applications, such as enzyme replacement therapy for genetic diseases.
• Fusion Proteins: Combining therapeutic proteins with other functional proteins to enhance their therapeutic properties through customized glycosylation.
• Vaccines: Altering glycosylation patterns to enhance immunogenicity and generate a strong immune response.

Our Technology Platforms

Advantages of Therapeutic Protein Production From Glyco-Engineering

• Customized glycosylation can enhance the biological activity of therapeutic proteins.
• Reduce glycan heterogeneity to ensure batch-to-batch consistency and minimize unexpected immunogenic reactions.
• Modifying glycosylation patterns can extend the half-life of therapeutic drugs, thereby reducing the frequency of dosing.
• Effectively reduce the immunogenicity of therapeutic proteins and reduce immune responses in the body.
• Designing targeted delivery systems, through specific glycan recognition, can guide drugs to precisely reach target cells or tissues, improve therapeutic effects and reduce side effects.

Why Choose Us for Therapeutic Protein Production Using Glyco-Engineering?

• We are at the forefront of glycosylation engineering innovation, ensuring optimized glycosylation patterns to improve protein stability, efficacy, and safety.
• Our team consists of highly skilled scientists with deep knowledge and experience in glycoengineering technologies.
• We utilize cutting-edge technologies such as CRISPR and other gene editing tools to modify glycosylation patterns.
• We provide scalable therapeutic protein production solutions, from small-scale laboratory experiments to large-scale production for clinical trials and commercialization.
• Our optimized protocols reduce production time, speed up the development process, and bring your product to market faster.

Publication

CD Formulation's expertise in glyco-engineering enables us to offer our customers tailor-made solutions, both in the early R&D phase and at large-scale production. Please don't hesitate to contact us if you are interested in our services. We look forward to cooperating with you.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.