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Posted on 10/17/2024 15:55Modified on 10/17/2024 15:55

Samsung Biologics launches high-concentration formulation platform to accelerate high-dose drug development

S-HiConTM is designed to maximize drug delivery and stability through high-concentration formulation

[Press Release] On October 14, Samsung Biologics, a global contract development and manufacturing organization (CDMO), launched a new high-concentration formulation platform to support the development and manufacturing of high-dose biopharmaceuticals.

S-HiConTM can proactively identify unintended pH changes, enhance formulation stability, and reduce viscosity to ensure efficacy and maximize drug delivery. Through optimization of pH, buffer species, and excipients, along with a preliminary ‘Concentration Gate Check’ process, the platform tests formulation feasibility in the initial stages to identify favorable candidates and minimize potential risks associated with high concentration development.

Additionally, S-HiConTM integrates analytical capabilities to ensure that critical formulation challenges associated with viscosity and protein aggregation are addressed (Figure 1). Samsung Biologics has recorded over 200 mg/mL for liquid formulations, with adequate viscosity and improved stability.

"Our new platform will enable us to provide innovative solutions for clients requiring low to ultra-high concentration formulation to develop advanced therapeutics," said Brian Hosung Min, Executive Vice President and Head of CDO Development. "Samsung Biologics is committed to providing customized services by leveraging our expertise and track record in contract development."

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