Improving Therapeutic Protein Efficacy Through Charge Profile Adjustment

By Seulki Lee, Jiyeon Lee, Taeyoen Lim, and Jaewoon Kim, Samsung Biologics

Charge variants, resulting from post-translational modifications or chemical degradation, are a significant concern in monoclonal antibody (mAb) development and manufacturing. Shifts in isoelectric point (PI) values can lead to charge heterogeneity, impacting drug efficacy and safety.

Controlling charge variants is crucial for regulatory approval and clinical success. However, it can be challenging due to the complex nature of charge heterogeneity and the potential for unintended consequences when implementing process changes.

Key considerations for managing charge variants include:

• Early monitoring: Adequate measurement of charge variants throughout development is essential for identifying and addressing potential issues early on.
• Process optimization: Understanding the factors that influence charge variant formation can help optimize manufacturing processes to minimize their occurrence.
• Risk assessment: Identifying and mitigating risks associated with charge variants is crucial for ensuring product quality and safety.

By carefully considering these factors and implementing effective control strategies, developers can mitigate the risks associated with charge variants and deliver high-quality mAb products to patients.