바이오스펙테이터

바이오스펙테이터 Jongwon Jang 기자

Samsung Biologics received 45 projects in two years after entering the Contract Development Organization (CDO) business. In particular, the company has increased the proportion of domestic companies to 75% by working on collaboration with domestic bio-ventures. Samsung Biologics plans to expand their CDO business by securing a CAPA that can carry out 40 projects per year by 2021.

Eun Young Yang, Head of CDO Business Team, explained the status and future plans of Samsung CDO business at a meeting held at Hotel Whitcomb in San Francisco, USA, on December 12th (local time).

Samsung Bio, which started as a CMO, entered the CDO business in 2018, which consults with clients on clinical trials, from developing cell lines to producing clinical substances. Through this business, the company established a one-stop support service for the entire new drug development process from Investigational New Drug (IND) to Biologic License Application (BLA).

Yang said, “Samsung has our own commercialization facility (CMO), which saves more than a year and $ 20 million in costs for companies to convert clinical trial drugs from small bioreactors to commercial production.” "It's also our strategy not to tie customers into royalties or milestones (to facilitate technology transfer)," she said.

Samsung's CDO service timeline pulled 11 months from cell line development to drug substance production and 14.5 months from cell line development to IND Filing. Four 1000 liter bioreactors were also secured for the CDO business.

They are also using Beacon, the latest equipment to develop CDO cell lines. Beacon is a device used to develop cell lines for CDO services as an incubator (for cell culture), a single cell sorter (separating cells from one another), and a titer (digitizing antibody cells in culture fluid) measuring device. It is a device capable of selecting cell lines of high quality.

Since launching their business in 2018, Samsung Biologics has signed 45 CDO contracts with 20 clients, including GI-Innovation, Eutilex, and Immuneoncia. Especially, the focus on collaboration with domestic bio-ventures increased the percentage of domestic companies to 75%. Currently, 30 companies and 40 product CDOs are under discussion.

Yang said, "The goal is to receive various CDO projects from the CMO stage and to the BLA". "We plan to expand the CAPA to allow more than 40 projects per year by 2021." "The goal is to secure 50% of the global CDMO market and become a TSMC (Taiwan Semiconductor Manufacturing Co. Ltd.) in bio industry".

Samsung Biologics said, "We will lead the establishment of a win-win model between large companies and venture companies in K-Bio." " Based on our excellent capabilities, we will become a growth partner in which Korean bio-venture companies actively cooperate in strengthening their global competitiveness by reducing the cost and time required to develop medicines and enhancing brand value.”