Samsung Biologics Introduces High-Concentration Platform for Next-Gen Drug Formulations

Samsung Biologics, a leading global contract development and manufacturing organization (CDMO), has established its new high-concentration formulation platform known as S-HiConTM, which is designed to assist in developing and manufacturing high-dose biopharmaceuticals.

S-HiConTM aims to detect unpredicted pH fluctuations, improve formulation stability, and lower viscosity to enhance drug delivery and efficacy. The platform estimates formulation feasibility early on by optimizing pH levels, buffer species, and excipients, along with an initial ‘Concentration Gate Check’ process to identify promising candidates and reduce risks linked to high concentration development.

Moreover, S-HiConTM incorporates analytical capabilities to tackle critical formulation issues such as viscosity and protein aggregation. Samsung Biologics has achieved over 200 mg/mL in liquid formulations with suitable viscosity and enhanced stability.

This new platform indicates Samsung Biologics’ commitment to offering clients innovative technologies that provide high-quality development. By leveraging platforms that boost antibody-dependent cellular cytotoxicity (ADCC) activity and improve upstream process quality, the company aims to meet the evolving needs of its clients better and support their pipelines.

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