On 29th, Samsung Biologics (CEO Tae-han Kim) held an online opening ceremony for its San Francisco Contract Development Organization(CDO) Research & Development (R&D) Center.

Samsung Biologics established the center that implemented the headquarters' CDO R&D platform to focus on meeting the demand for contract development services in the western United States. Moreover, by realizing the 'one-stop service' of CRO-CDO-CMO, the company has set a goal to become the best company in each of them.

"In San Francisco, the mecca of the biopharmaceutical industry, there are about 2,500 life science companies. Also, since San Francisco is advantageous in terms of connectivity with the headquarters to successfully construct the initial global CDO R&D center, we chose San Francisco as the first destination," said Tae-han Kim, CEO of Samsung Biologics. "After 2020, the next 10 years will be the period for global expansion to Boston, Europe, and China. Through this expansion, we will endeavor to maximize customer satisfaction in the entire process of research, development, and manufacturing (CRO/CDO/CMO) of new biopharmaceuticals."

▲ Tae-han Kim, CEO of Samsung Biologics

◆ Full-fledged global expansion to become a Next Door CDO partner

Samsung Biologics' San Francisco CDO R&D Center has the same state-of-the-art CDO service platform as the one at the Incheon Songdo headquarters. It was opened on a minimal scale initially, and it will be expanded in accordance with the increasing demand of clients in the future. Through this center, the company announced to become a 'Next Door CDO Partner' that supports clients' drug development process through closer and faster communication with local Big Pharma and Biotech. As a result, Samsung Biologics has resolved the parallax and low geographic access concerns raised by some overseas clients.

Samsung Biologics plans to additionally build CDO R&D centers in Boston, Europe, and China at the major bio clusters where potential clients are concentrated to strengthen accessibility further. "We plan to open CDO R&D centers in the eastern United States and Western Europe in 2021. China is relatively advantageous in terms of the parallax and geographical elements, so the headquarters in Songdo, Incheon will manage for the meantime. However, as potential clients are rapidly increasing, we still have a plan to establish the CDO R&D center in China in the future," said Kim.

On the other hand, securing more than 60 order contracts within two years since entering 2018, Samsung Biologics' CDO business grows fast with revealing its prominence in the global market. The company has successfully received both FDA & EMA regulatory approvals. Besides, GI Innovation Inc.'s drug candidate, which was consigned from the cell line development stage to Samsung Biologics, was exported for 900 billion won ($793 million) to Jiangsu Simcere Pharmaceutical Co., Ltd.

In particular, Samsung Biologics is putting a lot of efforts in the CDO business to secure speed and price competitiveness with the slogan 'Faster & Better'. It drastically shortened the time required from cell line development to raw material drug production to 6 months and final product production to 7 months. This is about twice as fast as the 12-month development period of the same category currently promoted by major global companies.

▲ Samsung Biologics presented its vision as a one-stop CDMO service partner.

◆ Killing three birds with CRO-CDO-CMO end-to-end service

Samsung Biologics has been proliferating since it entered the bio-industry in 2010 with its biopharmaceutical CMO business. Currently, it has three large biopharmaceutical production facilities, with a total of 364,000 liters. The 4th factory is scheduled to be ready for GMP operation from the end of 2022, and when it goes into operation, Samsung Biologics will have a total production scale of 620,000 liters.

Samsung Biologics is more than the world's largest production CMO. It announced a strategy to maximize customer satisfaction through 'end-to-end one-stop service' system ranging from CRO (contract research), CDO (contract development), and CMO (contract manufacturing. For this, in succession to the CDO market advance in 2018, the company recently expanded its business to CRO. It has set a goal to establish itself as the best global CRO company in 2030, starting with a CRO business that includes antibody production service.

The 4th factory was designed as the final edition of a one-stop service available within one factory from cell line development to end-product manufacturing. Based on this one-stop service, Samsung Biologics plans to secure 50% of the CMO volume through the CDO business by 2030.

"Samsung Biologics started from a mudflat in Songdo, but achieved the CMO champion in 2020. We aim to achieve the CDO global champion by 2022, starting with the first overseas CDO R&D center in San Francisco. In the case of CRO business, Samsung Biologics will expand new bio drugs and antibodies production in earnest, and challenge the CRO global champion by 2030," said Kim. "Through the one-stop service, biotech clients could develop, produce, and manufacture new bio drugs with better efficacy and quality at a lower cost. Ultimately, Samsung Biologics aims to contribute to improving human health and the quality of life."


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