Samsung Biologics launches new high-concentration drug formulation platform

Samsung Biologics said it officially launched its high-concentration drug formulation platform S-HiCon on Monday. With the launch of the platform, the company has introduced four new CDO platforms this year, bringing its total portfolio to nine.

The company unveiled the platform during the BIO Japan 2024 event held from last Wednesday to Friday in Yokohama, Japan.

During the event, the company showcased S-HiCon to potential clients and attendees.

The launch of S-HiCon comes in response to the rising demand for high-concentration drug formulations, particularly for subcutaneous and ophthalmic injections. High-concentration formulations require smaller doses compared to low-concentration drugs, which leads to lower storage and transportation costs—factors that have driven their growing market demand.

However, challenges such as increased viscosity and changes in pH levels often arise during the development of high-concentration formulations.

Samsung Biologics stressed that it has overcome these issues by selecting the right excipients, enabling the company to successfully accumulate data for ultra-high-concentration formulations exceeding 200 mg/mL. In the pharmaceutical industry, formulations above 150 mg/mL are considered high-concentration, while those above 200 mg/mL fall into the ultra-high category.

One innovative feature of the S-HiCon platform is the addition of a concentration gate check step, which allows developers to confirm whether a formulation can be concentrated to the desired level before fully proceeding with development. This step helps reduce the risk of failure in high-concentration drug development.

Samsung Biologics expects that the platform will enhance its contract development organization CDO services by expanding its capabilities to develop formulations ranging from low to ultra-high concentrations.

"We expect that by providing formulation development services ranging from low to high concentrations, various types of drugs will be able to enter the market more quickly," Samsung Biologics CDO Development Center Leader Min Ho-sung said. "We will continue to develop innovative technologies and services to provide tailored solutions for our clients."