Overcoming Challenges To High-Concentration Formulation Development

By Heonchang Lim, Director of Formulation Development

High-concentration therapeutic antibodies are becoming a cornerstone of the biopharmaceutical market, as they offer enhanced efficacy for treating a wide range of diseases. This growing demand has led to an increased focus on developing formulations that effectively balance stability, manufacturability, and patient convenience. However, formulating robust high-concentration protein therapies presents a host of unique challenges, such as managing high viscosity, preventing aggregation, avoiding phase separation, and addressing pH variability, all of which can significantly impact product quality and patient outcomes.

To overcome these hurdles, Samsung Biologics has developed the S-HiCon™ platform — a comprehensive, science-driven solution tailored to optimize high-concentration formulations. This platform employs advanced analytical techniques, emphasizes strategic risk mitigation, and follows a stepwise process development approach to ensure the stability and manufacturability of these complex formulations. By leveraging S-HiCon™, Samsung Biologics offers biopharma companies a powerful tool to overcome the challenges of high-concentration protein formulations and deliver safer, more effective therapies to patients.