Samsung Biologics announced Monday that it has launched S-HiCon, a new platform specializing in high-concentration formulation development, designed to meet rising demand for high-concentration biopharmaceuticals.
The company officially introduced the platform at Bio Japan 2024, a biotechnology expo held from Wednesday to Friday in Yokohama, Japan. A webinar explaining the platform was also released via the company's official website Monday.
S-HiCon is designed to meet increasing market demand for high-concentration drugs, which offer advantages such as reduced dosage for subcutaneous and ophthalmic injections compared to lower-concentration formulations. These drugs also help reduce storage and transportation costs, making them an attractive option in the pharmaceutical industry.
Developing high-concentration formulations has traditionally been challenging due to issues like increased viscosity and pH fluctuations. However, Samsung Biologics has addressed these challenges by selecting appropriate excipients, successfully accumulating data for ultrahigh-concentration formulations exceeding 200 milligrams per milliliter. Typically, formulations with concentrations above 150 milligrams per milliliter are considered high, while those over 200 milligrams per milliliter are classified as ultrahigh.
To further mitigate development risks, Samsung Biologics introduced a new process called the "concentration gate check," which enables verifying if the desired concentration is achievable before committing to full-scale development.
With the launch of S-HiCon, Samsung Biologics has expanded its formulation development capabilities from low to ultrahigh concentrations, strengthening its contract development services. This platform is Samsung Biologics' fourth contract development platform launched this year, bringing its total to nine.
"We expect that offering formulation development services from low to high concentrations will help clients bring a wider range of drugs to market more quickly," said Min Ho-sung, executive vice president of Samsung Biologics' CDO Center. "Samsung Biologics will continue to develop innovative technologies and services to deliver tailored solutions to our clients."
