Optimization of Sialylation
Emerging research highlights the critical role of IgG sialylation patterns in modulating therapeutic outcomes for autoimmune and inflammatory disorders. To address the growing need for targeted therapies, Creative Biolabs has engineered a cutting-edge platform for biosynthesizing sialylated IgG Fc domains through advanced glycoengineering technologies. Our science-driven solutions leverage precision modification of Fc glycosylation profiles to create next-generation biologics with enhanced anti-inflammatory properties, offering a standardized and potentially more efficacious alternative to conventional IVIg therapies.
The Necessity of Optimization of Sialylation
Sialylation, the addition of sialic acid to glycans, is a critical post-translational modification that significantly impacts the biological activity of therapeutic proteins, particularly antibodies. Sialic acids, often found at the terminal positions of glycans, influence protein stability, half-life, and immunogenicity. Research highlights the crucial role of sialic acids in various biological processes, including signal transduction and immunogenicity, and their importance in biopharmaceuticals for promoting stability and activity. As a result, it is necessary to optimize the sialylation to improve the efficacy of therapeutics.
Fig.1 Sialylated IgG has been linked to autoimmune disorders.1
Optimization of Sialylation at Creative Biolabs
At Creative Biolabs, our sialylation optimization service provides comprehensive solutions to tailor the sialylation profile of your therapeutic proteins to meet specific requirements. We offer expertise and technologies to address the challenges associated with achieving desired sialylation patterns. Our approach extends beyond the mere addition of sialic acids; it encompasses a consideration of the precise location, linkage, and density of sialylation, all of which exert a significant influence on the ultimate therapeutic outcome. Different therapeutic proteins have specific sialylation needs. Considering this, we leverage a combination of advanced techniques, including host cell engineering, process optimization, and analytical characterization, to achieve the optimal sialylation profile for each specific therapeutic protein. Throughout the whole process, we ensure standardized operations to deliver high-quality results for all customers.
Our Service Workflow
Initial Consultation and Design: We start with an in-depth consultation to grasp your project objectives, desired sialylation profile, and any particular specifications you may have. Based on this, we design a customized optimization strategy.
Host Cell Engineering: We employ advanced host cell glycoengineering techniques to modify the glycosylation machinery of the host cells. This may involve gene editing, overexpression of specific sialyltransferases, or knockout of competing enzymes.
Cell Line Development: We develop stable cell lines that consistently produce proteins with the desired sialylation pattern. This includes cell line selection, optimization of culture conditions, and clonal selection.
Process Optimization: We optimize cell culture parameters, such as nutrient levels, pH, temperature, and media composition, to further enhance sialylation levels and consistency.
Analytical Characterization: We perform comprehensive glycan analysis using state-of-the-art techniques (e.g., mass spectrometry, HPLC) to characterize the sialylation profile of the produced proteins. This ensures that the desired modifications have been achieved.
Scale-up and Production Support: We provide support for scale-up and production, including process transfer and optimization for large-scale manufacturing.
Essential Initial Components
In order to successfully start the sialylation optimization project, we usually require customers to provide the following information. For special needs, please contact our team for professional answers.
- Protein sequence or gene sequence of the therapeutic protein.
- Information on the host cell line currently used for protein expression.
- Existing glycosylation data (if available), including glycan profiles and sialylation levels.
Advantages
- Advanced technologies
- Competent research team
- Extensive expertise and experience
- Accelerated project delivery
FAQs
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Q1: What types of proteins can benefit from sialylation optimization?
A1: Therapeutic proteins, including antibodies, Fc-fusion proteins, and other glycoproteins, can benefit significantly from sialylation optimization. Sialylation can enhance their stability, efficacy, and safety. Contact us to discuss your specific protein of interest.
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Q2: Can you help with the large-scale production of sialylated proteins?
A2: Yes, we provide support for scale-up and production, including process transfer and optimization for large-scale manufacturing. We can work with you to ensure a smooth transition from development to commercial production. Inquire now to learn more about our scale-up capabilities.
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Q3: How does sialylation optimization compare to other glycoengineering approaches?
A3: Sialylation optimization is a specific glycoengineering strategy focused on enhancing the addition of sialic acid residues. While other approaches, such as fucosylation or galactosylation modification, target different aspects of glycosylation, sialylation optimization is particularly important for improving protein stability, reducing immunogenicity, and enhancing anti-inflammatory activity. Let us help you determine the best glycoengineering approach for your specific needs.
Related Services
Creative Biolabs offers a comprehensive suite of glycoengineering services to complement our Sialylation Optimization service:
- Antibody Glycosylation Analysis
- Host Cell Glycoengineering
- Non-Glycosylation or Simplified-Glycosylation
- Optimization of Galactosylation and Degree of Branching
- Fully Human Glycosylation
Work with Creative Biolabs
Creative Biolabs is a leading provider of glycoengineering services, with extensive expertise in sialylation optimization. Our advanced Antibody GlycoOptimize™ Platform and experienced scientists ensure high-quality results and tailored solutions to meet your specific needs. If you want to optimize your therapeutics' sialylation, please don't hesitate to contact us.
Reference
- Li, Danqi, et al. "Sialylated immunoglobulin G: a promising diagnostic and therapeutic strategy for autoimmune diseases." Theranostics 11.11 (2021): 5430. Distributed under Open Access License CC BY 4.0, without modification.
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