A Future-Oriented Business That Anticipates Bio Trends
164 Cumulative CDO Contracts in Eight Years Since Launch
Over 50% of Projects Now Involve Complex Modalities Like Bispecific Antibodies and ADCs
At the JP Morgan Healthcare Conference, Samsung Biologics highlighted its contract development (CDO) capabilities, making clear its goal to achieve a significant competitive edge in the CDO sector as well.
Sangmyung Lee, Executive Director in charge of CDO Development at Samsung Biologics, is explaining the current business status at the CDO Division briefing held on the 15th (local time) in San Francisco, USA. Samsung Biologics
At a press conference held on January 15 (local time) in San Francisco, California, Sangmyung Lee, Executive Director in charge of CDO Development and Head of Business Strategy at Samsung Biologics, stated, "For our clients, CDO is a service where the development timeline is directly linked to their survival. For Samsung Biologics, it is a business that allows us to detect the products and technology trends that will be manufactured under contract (CMO) in five to seven years, enabling us to prepare for the future." He continued, "We aim to establish ourselves as a full-cycle partner by completing an end-to-end platform that connects CRO (Contract Research Organization), CDO, and CMO." The key theme for this year's CDO strategy is 'Technology-Driven Leadership.' Lee outlined three main pillars: securing early partnerships for 'early lock-in,' operating as a data-driven CDO, and responding to complex multimodality challenges.
As Lee explained, the CDO process involves clients providing genetic information for candidate substances such as antibodies, after which Samsung Biologics develops cell lines and production processes (cultivation and purification), and then produces and supplies preclinical and clinical materials. The company also compiles data packages for Investigational New Drug (IND) applications, supporting clients in entering actual clinical trials. While the top priority for CMO is 'on-time delivery'-supplying products by the promised deadline without quality issues-CDO places the highest value on 'developability and development timeline.' Especially for biotech clients, who must achieve results within a set timeframe to maintain funding, "how reliably the timeline is maintained" becomes the key criterion for selecting a supplier.
Sangmyung Lee, Executive Director in charge of CDO Development at Samsung Biologics, is explaining the current business status at the CDO Division briefing held on the 15th (local time) in San Francisco, USA. Samsung Biologics
Since launching its CDO business in 2018, Samsung Biologics has signed a total of 164 contracts (including 5 ADC projects) over eight years and has obtained 49 IND approvals. The company's portfolio extends beyond monoclonal antibodies. Sangmyung Lee noted, "Of the 164 accumulated projects, more than half now involve complex modalities, such as bispecific antibodies (20%), ADCs (15%), and fusion proteins (14%)." He added, "Recently, the proportion of complex modality projects has been increasing even further." From a clinical approval perspective, "Initially, approvals were mostly domestic, but now, cumulatively, about 50% of cases have been approved by the FDA or EMA," emphasizing the company's global expansion.
The methodology for achieving a 'significant competitive edge' centers on 'nine platforms' and 'speed.' Samsung Biologics explained that after launching its proprietary cell line platform, S-CHOice®, in August 2020, it now possesses nine CDO technology platforms. These platforms provide the necessary technical capabilities at each stage, from late discovery to IND application. The company also quantified its speed advantage: for monoclonal antibodies, the development period from cell line creation to IND application has been reduced from the industry standard of 11 months to 9 months; for bispecific antibodies, from 13 months to 11 months. For ADCs, the company aims to provide a standard development timeline of 14.5 months from antibody development and conjugation to drug substance (DS) production. Sangmyung Lee emphasized, "While there is room to shorten the timeline further by taking on additional risk and conducting parallel processes, our priority is to reliably provide a standard timeline."
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