Samsung Biologics is further strengthening its "super-gap" strategy in the contract development organization (CDO) field for biopharmaceuticals. By linking the contract research organization (CRO) business "Samsung Organoid" unveiled last year with its CDO business, the company aims to solidify technology-based leadership across the entire contract research, development and manufacturing organization (CRDMO) spectrum.
Executive Director Lee Sang-myeong of Samsung Biologics (head of CDO development and head of business strategy) on Jan. 15 (local time) outlined this year's key CDO business strategies for Samsung Biologics during a press roundtable at a hotel near the JP Morgan Healthcare Conference venue in San Francisco.
Lee said, "In the first quarter of this year, we will begin full-scale provision of the 'master cell bank (MCB),' which establishes, freezes and stores cell lines, and the 'vector synthesis service,' which designs and synthesizes expression vectors for producing therapeutic proteins tailored to customer needs." He added, "We will also launch a new platform based on transposase that boosts efficiency in producing high-difficulty biopharmaceuticals."
MCB, the core of biopharmaceutical production, involves massively culturing the final cell line that best produces the target protein, dividing it into hundreds to thousands of vials, and storing them frozen.
The vector synthesis service designs and manufactures vectors needed to produce therapeutic proteins, antibodies, vaccines and gene therapies, tailored to customer requirements. It supports up to the design stage of carrying genes so that desired proteins can be efficiently produced inside cells.
Lee explained, "By including MCB and vector services within the CDO scope, we can strengthen protection of clients' intellectual property (IP) and shorten development timelines by reducing logistics time."
The transposase-based platform is a technology that inserts genes by using transposases that recognize specific DNA sequences during the cell line development process. By inserting genes at positions with the highest transcriptional activity, it can increase protein expression and secure stability. This can raise production efficiency for high-difficulty biopharmaceuticals such as antibodies and Antibody-Drug Conjugate (ADC).
This is a strategy to strengthen competitiveness in so-called "end-to-end" contract services that cover client needs from development through manufacturing. Based on its contract manufacturing organization (CMO) competitiveness, the company is gradually expanding its CDO and CRO capabilities. It entered the CMO business upon its founding in 2011 and launched its CDO business in 2018. In June last year, it unveiled the CRO service "Samsung Organoids," accelerating its CRDMO strategy.
By collaborating from the candidate discovery stage, which precedes clients' new drug development and the CMO, the company aims for a lock-in effect—securing commercialization orders by binding customers like a lock.
According to Lee, in the eight years since the CDO business launch, cumulative contract wins total 164 (including 5 for ADC), with 49 investigational new drug (IND) approvals obtained. The company currently operates nine CDO technology platforms that support from late discovery to IND filing.
Speed competitiveness is also a strength. From cell line development to IND approval, monoclonal antibodies take nine months and bispecific antibodies take 11 months, each two months shorter than the industry standard. For ADCs, through co-development with antibodies, the company presents a standard development timeline of 14.5 months through drug substance production.
Lee explained, "We have advanced our existing cell line platform 'S-CHOice®' to a second generation, and by introducing new vectors and developing parental cells, we have raised antibody productivity from the previous 7 g/L to up to 13 g/L."
The company is also expanding its capability to address modalities (drug targeting mechanisms). Lee said, "Beyond monoclonal antibodies (mAb), we are continually expanding CDO services for high-difficulty complex molecules such as bispecific antibodies, fusion proteins and antibody conjugates (AXC)," adding, "Of the 164 cumulative projects, bispecifics account for 20%, Antibody-Drug Conjugate (ADC) for 15%, and fusion proteins for 14%."
Bispecific antibodies are antibodies that target two antigens simultaneously, and fusion proteins are antibodies combined with other proteins. ADCs and AXCs are classified as high-difficulty complex therapies in which drugs, oligonucleotides or peptides are conjugated to antibodies.
The company has also secured ADC drug product (DP) manufacturing capability and plans to officially launch ADC DP services in the first quarter of 2027. Through this, it aims to build an integrated service that spans ADC drug substance (DS) to drug product (DP), strengthening competitiveness in high value-added modality areas.
Lee said, "Samsung Biologics is establishing itself as a partner that accompanies the entire new drug development lifecycle by combining clients' ideas with our own technology, know-how and infrastructure," adding, "We will continue to improve customer satisfaction through seamless one-stop services, advanced technology and rapid development."