Resource Library
Improving therapeutic protein efficacy through charge profile adjustment
Charge variants are an important focus of analytical evaluation for monoclonal antibody (mAb) therapies. This whitepaper discusses how our advanced charge variant modulation platform, S-OptiCharge™, enables stepwise upstream process development while allowing for precise tuning of charge profiles to meet the target quality specifications of therapeutic proteins. Read more
Understanding, monitoring, and analyzing charge variants during biologics development
Charge heterogeneity is a critical aspect of product quality and should therefore be carefully monitored throughout the biologics development process. Variations in protein charge, resulting from modifications such as deamidation, oxidation, and glycosylation, can impact an antibody’s safety, efficacy, and overall consistency. Understanding the factors influencing charge variant formation is essential for optimizing processes and ensuring regulatory compliance.
Therapeutic charge variant case studies:
This whitepaper includes three case studies that highlight the value of Samsung Biologics’ S-OptiCharge™ platform:
- Case study A: The impact of additives on charge variants
- Case study B: Modulating charge variants through basal and feed media screening
- Case study C: A DoE approach for charge variant control
Charge variants are an important focus of analytical evaluation for monoclonal antibody (mAb) therapies. This whitepaper discusses how our advanced charge variant modulation platform, S-OptiCharge™, enables stepwise upstream process development while allowing for precise tuning of charge profiles to meet the target quality specifications of therapeutic proteins. Read more
Understanding, monitoring, and analyzing charge variants during biologics development
Charge heterogeneity is a critical aspect of product quality and should therefore be carefully monitored throughout the biologics development process. Variations in protein charge, resulting from modifications such as deamidation, oxidation, and glycosylation, can impact an antibody’s safety, efficacy, and overall consistency. Understanding the factors influencing charge variant formation is essential for optimizing processes and ensuring regulatory compliance.
Therapeutic charge variant case studies:
This whitepaper includes three case studies that highlight the value of Samsung Biologics’ S-OptiCharge™ platform:
- Case study A: The impact of additives on charge variants
- Case study B: Modulating charge variants through basal and feed media screening
- Case study C: A DoE approach for charge variant control