Formulation Considerations For The Development Of High Concentration Biopharmaceuticals

The biopharmaceutical industry is increasingly focused on developing highly concentrated formulations to improve patient convenience and compliance, particularly through subcutaneous administration. Higher-concentration drug products, especially those exceeding 100 mg/mL, offer several benefits but come with unique challenges. These formulations often face issues such as increased aggregation, the formation of subvisible particles, higher viscosity, and process development complications like Donnan Effects. To overcome these challenges, it’s critical to develop effective strategies that streamline the formulation process.

This webinar delves into the complexities of developing high-concentration biopharmaceutical formulations. The session will address key obstacles—such as opalescence, viscosity, and aggregation—and present real-world case studies on how composition changes during the concentration process can be effectively characterized. You’ll also learn about practical strategies that Samsung Biologics employs to develop stable, high-concentration drug products.

Key Learning Objectives

• Understand the Challenges: Gain insights into the primary issues associated with high-concentration formulations, including stability and manufacturability concerns.
• Formulation Principles and Tools: Learn the fundamental principles and tools essential for the successful development of high-concentration biopharmaceutical products.
• Samsung Biologics’ Practical Strategies: Discover how Samsung Biologics approaches these challenges with cutting-edge strategies, including small-scale tangential flow filtration to monitor pH shifts, feasibility spikes, and advanced screening methods.

Topics Covered

• Small-Scale Tangential Flow Filtration: Understand how pH shifts affect formulation stability and how to manage them.
• Feasibility of Concentration Spikes: Learn about small-scale spikes and how they can help achieve target pH and osmolality.
• Screening Methods for High-Concentration Formulations: Explore advanced techniques such as HIAC dilution and SEC dilution to evaluate formulation viability.

Featured Speaker

Heonchang Lim
Director of Formulation Development, Samsung Biologics

Heonchang Lim is the Director of Formulation Development at Samsung Biologics, where he leads a team dedicated to the innovation and development of high-concentration biopharmaceutical formulations. With over 15 years of experience in the biopharmaceutical sector, Heonchang has specialized in the formulation of protein drugs and vaccines, having successfully managed more than 50 projects related to formulation development and non-GMP DP manufacturing.

Heonchang has also played a pivotal role in launching DEVELOPICK™, a platform that evaluates target molecules to streamline drug development. Prior to joining Samsung Biologics, he worked at LG Chem, where he contributed to R&D efforts in purification and formulation for a variety of vaccine and protein drug projects. He holds a master’s degree in medicine from Seoul National University and a bachelor’s degree in molecular biology from Catholic University.