Biotechnology has had a dramatic impact on the pharmaceutical industry in recent decades, with biopharmaceuticals now used to treat diseases ranging from cancer to COVID-19. These biological medicines are developed using biological sources such as cells, mRNA, and antibodies. Samsung Biologics, one of the world’s largest contract development and manufacturing organizations (CDMO), has been on the cutting edge of this evolution as an established provider of monoclonal antibody development and manufacturing services, and now it’s continuing to pursue innovative developments in biologics with its new bispecific antibody platform: S-DUAL™.
S-DUAL™ was launched concurrently with DEVELOPICK™, Samsung Biologics’ rapid developability assessment platform for screening molecules.
“Through these new development technologies, we provide early insight and ensure the higher yield of molecules, ultimately enabling clients to reach commercialization much more efficiently,” said Samsung Biologics CEO and President John Rim in a statement on the platform’s launch at the 2022 BioProcess International Conference and Exhibition held in Boston in September.
What Are Bispecific Antibodies?
Antibodies are molecules that target and bind to antigens in the body to fight diseases. Monoclonal antibodies, which represent the bulk of biological medicines, target a single antigen. While researchers have made much progress in designing monoclonal antibodies that target a variety of diseases, these molecules remain only capable of targeting one antigen at a time.
By contrast, bispecific antibodies can target two distinct antigens simultaneously. This improves the degree of specificity of targets that biological medicine can impact. Many diseases arise from the interaction of several confluent factors. Monoclonal antibodies are limited to targeting one antigen at a time, potentially allowing other factors to remain active and mitigate the effects of a drug. On the other hand, bispecific antibodies can target multiple factors at the same time to increase effectiveness.
For example, a bispecific antibody used to treat cancer could bind to both an antigen on a cancer cell and to a T-cell receptor, uniting these two types of cells to activate an immune response that fights the targeted cancer.
This technology has obvious benefits, both in terms of developing more effectively targeted therapeutics and reducing the need to manufacture multiple targeted biologics to treat a single disease.
While these benefits have continued to drive research into the development and manufacture of bispecific antibodies, CDMOs have historically focused on monoclonal antibodies, which are easier to produce. Developing and manufacturing bispecific antibodies have presented challenges in terms of high immunogenicity and ensuring the proper chain pairings in the bispecific molecule.
However, developments in bispecific antibody technology have enabled Samsung Biologics to overcome these challenges and create a robust, efficient bispecific antibody development platform.
The new platform is designed to position Samsung Biologics as a leader in a growing market. According to Roots Analysis, a research and consulting firm, the global bispecific antibody market is expected to exceed $9 billion by 2030, increasing at an annual rate of 34%.
There remains wide-open growth potential in the market. For example, there are currently only two bispecific antibody cancer treatments approved by both the Food and Drug Administration and the European Medicine Agency.
How Does Samsung Biologics’ S-DUAL™ Platform Work?
Samsung Biologics designed the S-DUAL™ platform to produce high yields while ensuring chain-pairing success.
According to the CDMO, the platform has demonstrated a 99% chain-pairing success rate, relying on a unique asymmetrical structure to reduce chemistry, manufacturing, and control risks. This structure is meant to ensure binding affinity among chains, which helps optimize purity, efficiency, and stability in the manufacturing process.
When a CDMO produces antibodies using this method, there are eight possible combinations of chains, but only one is bispecific. However, the asymmetric design enables the S-DUAL™ platform to separate this one combination from the rest, recognizing impurities as improper pairings from different-sized molecules.
In addition, Samsung Biologics utilizes what is known as a “knob-into-hole” technique, which avoids mispairing between two heavy chains. S-DUAL™ also introduces CH3 dimer in the antibody’s fragment antigen-binding region to avoid mispairing between the heavy chain and the light chain.
S-DUAL™ also addresses the immunogenicity challenges by utilizing a structure that mimics human immunoglobulin gamma, a molecule known for strengthening weakened immune systems.
This combination of structural innovations allows the CDMO to use S-DUAL™ to produce a variety of bispecific antibodies to meet clients’ unique needs.
A Multidimensional CDMO
Samsung Biologics’ launch of both S-DUAL™ and DEVELOPICK™ in 2022 was part of what Rim calls the CDMO’s “multidimensional growth plan.” The plan is to grow the company across three pillars; increased manufacturing capacity, portfolio diversification, and an expanded international footprint.
In addition to the two new platforms, Samsung Biologics has diversified its portfolio by adding an end-to-end mRNA vaccine production facility at its headquarters in Songdo, South Korea, which completed its first commercial-scale run in August, manufacturing COVID-19 vaccines for GreenLight Biosciences.
The CDMO also completed the full acquisition of Samsung Bioepis, a biosimilar company that Samsung Biologics founded as a joint venture with Biogen in 2012, April.
Expanding capacity to produce antibodies remains a priority, with Samsung Biologics beginning partial operations at its newly constructed fourth plant in Songdo. Upon scheduled completion in 2023, Plant 4 will provide 240,000 liters of capacity, the most at any single facility in the world. This will bring Samsung Biologics to an industry-leading capacity of 604,000 liters.
Capacity will also be boosted by the construction of a second Bio Campus. The CDMO recently announced it had acquired 357,366 square meters (about 88.3 acres) of land, 30% larger than its current Bio Campus, for the construction of the new facility.
For Rim, this multidimensional pursuit of growth is key to becoming a leading global pharmaceutical company. The CDMO continues to expand, reporting record revenues in recent years and securing over 190 regulatory approvals. It’s also begun expanding internationally with its CDO R&D center in San Francisco.
“By expanding our business areas, we will evolve to become a global biopharmaceutical company with great responsibilities to better serve our clients, patients, shareholders, and ultimately society,” said Rim in his 2022 letter to shareholders.
