[BioUSA] Sambac Aims for CDMO Technology Dominance with 'Process Efficiency'

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"The key in Contract Development and Manufacturing Organization (CDMO) is improving process technology. We prioritize process efficiency even in antibody-drug conjugates (ADC) and others."

Jung Nam-jin, Head of Bio Research at Samsung Biologics (Vice President), is speaking at a meeting held on the 7th (local time) at the Boston Convention & Exhibition Center in the United States, where the BIO International Convention (BIO USA) is taking place.
[Photo by Lee Chun-hee]

Samsung Biologics, a CDMO company, has set process efficiency as a key task to extend its overwhelming production capabilities to new modality CDMOs. Having established a bio research institute last year to strengthen research and development (R&D) on emerging modalities, the company plans to complete production capabilities for ADCs and others by next year, aiming to quickly advance as a global top-tier bio company through this approach.

Namjin Jeong, Vice President and Head of Samsung Biologics Bio Research Institute, stated, "The Bio Research Institute aims to be a technology innovation research center. Until now, speed, quality, and capacity expansion were important, but for new modalities like ADCs and messenger RNA (mRNA) to grow, technological innovation is essential."

Mr. Jeong has built a diverse career over 28 years in the United States. He worked for 17 years as a researcher at global big pharma companies such as Merck (MSD), Bristol-Myers Squibb (BMS), and AbbVie. He also served as the inaugural director of the Laboratory for Genomic Research (LGR), established through collaboration between Nobel laureate Jennifer Doudna, who developed gene-editing technology, and GlaxoSmithKline (GSK). He joined Samsung Biologics as the first head of the Bio Research Institute in November last year.

Established in July last year directly under the CEO, the Bio Research Institute is expected to play a central role in expanding Samsung Biologics' three major growth pillars. It will lead the acquisition of technologies to secure capabilities for CDMO of modalities such as bispecific antibodies, mRNA, and ADCs, following the existing single antibody (mab) platform.

To this end, the Bio Research Institute has set up three experimental wet labs. The core antibody technology lab handles bispecific antibody technology represented by the 'S-Dual' platform and ADC technology based on current core antibody technologies. The gene therapy (GT) technology lab seeks and internalizes various cell and gene therapy (CGT) modalities, including mRNA. Lastly, the core technology lab researches gene editing, cell engineering, multi-omics, artificial intelligence (AI), machine learning, and data science.

Araris logo [Photo by Araris]

In particular, regarding the highly spotlighted ADC, Samsung Biologics recently invested in Araris, a Swiss ADC technology developer, through the Samsung Life Science Fund jointly established with Samsung C&T Corporation. The Bio Research Institute directly participated in Araris’ company scouting and due diligence.

Mr. Jeong emphasized that Araris’ technology aligns with Samsung Biologics’ strategic direction. Regarding Araris’ ADC technology 'AraLinker,' he said, "It has a tremendous advantage in that it can conjugate existing off-the-shelf antibodies brought by clients without modification," and evaluated it as "an ideal technology." He also explained the process efficiency, stating, "Processes involving multiple steps require more bioreactors and purification at each stage, making it complex. AraLinker is an innovative technology that can perform conjugation in a single step," highlighting its high process efficiency.

Previously, CEO John Rim also mentioned, "Many existing CMO oncology drugs are moving towards ADCs. Since we currently cannot produce them, they are outsourced elsewhere. If we can produce them, production within a single site becomes possible, which has generated much interest from clients." Therefore, if technologies like AraLinker are applied, Samsung Biologics’ existing antibody CDMO capabilities can be efficiently extended to ADC production. Mr. Jeong explained the current status, saying, "We are exploring whether there are parts of the technology that can be developed through joint research with Araris."

Samsung Biologics' bispecific antibody platform 'S-Dual'
Photo by Lee Chunhee

The S-Dual platform, launched in October last year, developed its 'second generation' within less than a year and filed a patent last month. The core of this is the 'knob & hole' technology. It places a handle (knob) and a hole, which bind in the same shape, between different antibodies to facilitate easier binding. In the second generation of S-Dual, the previously single knob & hole was increased to two. Mr. Jeong said, "Researchers kept thinking about how to improve it and came up with the idea of making two. The heterodimerization rate, which was 75% with one, increased to 85% with two." He added, "From a CDMO perspective, being able to produce precisely conjugated antibodies is a significant competitive advantage," and noted that experiments are underway to apply this to client projects.

However, Mr. Jeong also drew a line, stating that the likelihood of technologies developed through such R&D leading to new drug development is low. He explained, "R&D at Samsung Biologics is technological innovation aimed at expanding and growing the CDMO business and gaining competitiveness to become a world-class leader. The Bio Research Institute provides the portfolio technology part among the three major growth pillars."