Samsung Biologics Plant 3 (Image courtesy of Samsung Bioilogics)
SAN DIEGO, Jun. 4 (Korea Bizwire) – Samsung Biologics, a leading biopharmaceutical company, has unveiled a new platform and customized brand to strengthen its contract development and manufacturing organization (CDMO) capabilities in the biotech drug development arena.
At the 2024 BIO International Convention in San Diego, the company introduced its new CDMO platform, S-Tensify, designed to support the development of high-concentration biologic drugs by applying advanced cell culture technologies.
S-Tensify expands the scope of Samsung Biologics’ N-1 Perfusion technology, which was initially applied to contract manufacturing operations (CMO) in 2019. The N-1 Perfusion technique involves continuously circulating culture media through the bioreactor at the N-1 stage (just before the final cell culture stage), enabling simultaneous cell growth and waste removal. This approach allows for high-cell density cultivation by overcoming the limitations of traditional methods, where accumulated waste products hindered further cell density increases.
According to Samsung Biologics, the N-1 Perfusion method can increase the inoculation cell density at the N-1 stage by an average of 30 times, significantly boosting productivity when transitioning to the final cell culture stage (N).
In addition to S-Tensify, Samsung Biologics unveiled its new customized CDMO service brand, SelecTailor. This brand offers optimized chemistry, manufacturing, and controls (CMC) packages tailored to each client’s specific product characteristics and development strategies.
CMC activities encompass experimental methods and manufacturing process settings to ensure the safety and efficacy of candidate molecules.
Samsung Biologics explained that as new therapeutic modalities emerge and regulatory agencies expedite review processes, the importance of well-planned development strategies has increased. The company rebranded its Customized Development Solution, initially launched in August 2023, to meet this growing demand.
While Samsung Biologics initially focused on CMO services, it began actively pursuing CDMO operations in 2018. In 2022, the company launched the S-Dual bispecific antibody development platform and the Developick platform for evaluating developmental feasibility. Last year, Samsung Biologics expanded its CDMO platform and service offerings with the introduction of S-CHOsient for supporting early candidate generation and S-Glyn for facilitating molecule development.
As a result of these efforts, Samsung Biologics has secured 116 CDMO contracts from 2018 through the first quarter of 2024. In February, the company signed a CDMO agreement with the domestic biotech firm LigaChem Biosciences for the development of antibody-drug conjugates (ADCs).
Furthermore, Samsung Biologics plans to unveil three additional platforms within the year, including a Charge Variant Modulation Platform for media and additive screening, and a high-concentration formulation platform designed for 150 mg/mL subcutaneous administration.
Min Hosung, Head of the CDMO Development Center at Samsung Biologics, stated, “By offering customers their desired cell culture methods and services, we expect to help them reduce development risks and enter the market more quickly.” He added, “We will continue to develop innovative technologies and services to meet the diverse needs of our customers.”
Ashley Song (ashley@koreabizwire.com)
