Resource Library
S-Glyn™ : Optimizing N-Glycan profiles and their effector functions using a Design-of-Experiments approach
A clear understanding of a molecule's N-glycan profiles and their effector functions is fundamental for a successful IND journey, given that glycosylation during cell culture can impact the biological activity of the drug substance.
In this whitepaper, Junyong Park, Lead Scientist in Upstream Development highlights how our proprietary platform, S-Glyn™ evaluates N-glycan profiles and optimizes effector functions by leveraging a design-of-experiments (DoE) approach, resulting in streamlined development timelines. DoE and statistical analysis can be used to swiftly optimize and predict glycosylation patterns while deepening process knowledge and understanding.
DoE Studies for N-Glycan Optimization
Mammalian glycan structures are closely linked to immune functions. With the growing understanding of the relationships between abnormal glycan profiles and human diseases, glycoengineering has been widely adapted for antibody therapeutic development in oncology and immunology. CMC development with such antibody therapeutics is often challenged by stringent timelines. Identifying the myriad posttranslational modifications (PTMs) that can impact safety and efficacy is a complex and time-consuming aspect of that journey. Thoughtful application of design-of-experiments (DoE) strategies can significantly accelerate this activity. Here, we describe a DoE approach for the analysis of N-glycan profiles resulting from glycosylation and the relevant antibody effector functions that can impact drug performance. This work can be completed alongside process development and clinical material manufacturing, thereby reducing development timelines.
A clear understanding of a molecule's N-glycan profiles and their effector functions is fundamental for a successful IND journey, given that glycosylation during cell culture can impact the biological activity of the drug substance.
In this whitepaper, Junyong Park, Lead Scientist in Upstream Development highlights how our proprietary platform, S-Glyn™ evaluates N-glycan profiles and optimizes effector functions by leveraging a design-of-experiments (DoE) approach, resulting in streamlined development timelines. DoE and statistical analysis can be used to swiftly optimize and predict glycosylation patterns while deepening process knowledge and understanding.
DoE Studies for N-Glycan Optimization
Mammalian glycan structures are closely linked to immune functions. With the growing understanding of the relationships between abnormal glycan profiles and human diseases, glycoengineering has been widely adapted for antibody therapeutic development in oncology and immunology. CMC development with such antibody therapeutics is often challenged by stringent timelines. Identifying the myriad posttranslational modifications (PTMs) that can impact safety and efficacy is a complex and time-consuming aspect of that journey. Thoughtful application of design-of-experiments (DoE) strategies can significantly accelerate this activity. Here, we describe a DoE approach for the analysis of N-glycan profiles resulting from glycosylation and the relevant antibody effector functions that can impact drug performance. This work can be completed alongside process development and clinical material manufacturing, thereby reducing development timelines.