From Sept. 27-30, representatives from the leading companies in the biopharmaceuticals industry met for the BioProcess International 2022 conference in Boston. The event is the largest bioprocessing conference in the world, with over 1,800 experts from across the industry attending to discuss innovations in biologic medicine and approaches to accelerating commercialization. Samsung Biologics, a leading contract development and manufacturing organization (CDMO), unveiled two new proprietary drug development platforms at the conference: S-DUAL and DEVELOPICK.
As a CDMO, Samsung Biologics has expertise in both the development and the manufacturing sides of the industry, launching its development business in 2018. S-DUAL, a high-yield bispecific antibody platform, and DEVELOPICK, a developability assessment platform for the early-stage screening of molecules, are the latest additions to Samsung Biologics’ growing CDO business, which has secured over 100 contracts since its inception.
“We are excited to showcase our innovative platforms at the BioProcess International Conference this week,” said John Rim, CEO of Samsung Biologics. “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.”
The launch of the two new platforms follows Samsung Biologics’ opening of a CDO R&D facility in San Francisco in 2020 and the launch of its proprietary cell line, S-CHOice, in 2021.
About S-DUAL and DEVELOPICK
S-DUAL is a bispecific antibody platform that is capable of simultaneously targeting two distinct antigens. While naturally occurring antibodies are monospecific, targeting the same antigen with each of the antibody’s binding arms, bispecific antibodies have two distinct antigen binding sites and are thus capable of targeting separate antigens.
In the past, the construction of these bispecific antibodies has been considered more demanding due to the challenge of pairing four different polypeptide chains to create separate binding sites, but S-DUAL avoids heavy chain-light chain mispairing with an additional domain applied to the platform.
At the conference, Wonjun Yang, lead scientist for antibody-based research at Samsung Biologics, explained that the unique asymmetrical structure of the CDMO’s bispecific antibodies reduces risks associated with chemistry, manufacturing, and control, enabling high yields as high as 99%. He also outlined how the platform is designed to ensure high binding affinity among chains. The result is a high titer and purity for optimized manufacturability.
With the trademarked S-DUAL platform, Samsung Biologics is entering a growing market in the biologics space. The global bispecific antibody market is expected to grow at an annual rate of 34% to reach $9.6 billion by 2030, according to research and consulting firm Roots Analysis.
DEVELOPICK adds to Samsung Biologics’ arsenal of tools for assisting partners in advancing from the early development stage through the Investigational New Drug (IND) application and Biologics License Application (BLA) process. The platform requires only 20 milligrams of material to perform screenings that determine which drug candidates have the best potential for advancement. It enables the CDMO’s clients to conduct risk assessment analysis for unsorted drug candidates as fast as within a month, accelerating timelines by directing focus to the most promising drug candidates.
Responding to Growing CDMO Demand
Samsung Biologics’ expansion of its development capabilities comes as more companies are turning to CDMO partnerships in recent years.
The COVID-19 pandemic disrupted supply chains and led to the onset of mRNA vaccine production, as Moderna and Pfizer’s COVID-19 vaccines were the first mRNA vaccines approved for human use. These developments accelerated a trend of drug developers turning to CDMOs to both mitigate the risk of manufacturing disruption, as well as scale up development and manufacturing to meet increasing demand.
This trend has led to an increase in contract manufacturing organization partnerships but also to CDMOs becoming more involved on the development side in order to accelerate timelines and help guide drugs to the IND stage.
As demand for CDMO services has increased, the biologics market continues to grow as well, with new therapeutics in development across areas such as mRNA, biosimilars, cell and gene therapies, and antibodies. According to a recent report, the biologics market is expected to grow at an annual rate of 8.4% between 2021 and 2028 to reach a value of approximately $567.96 billion.
The launch of two new development platforms signals Samsung Biologics’ efforts to expand on both the development and manufacturing sides of this growing market. In addition to launching new antibody development platforms, the CDMO has also added mRNA vaccine drug substance capabilities and acquired full ownership of biosimilars firm Samsung Bioepis in 2022.
On the manufacturing side, Samsung Biologics continues to expand its industry-leading capacity, beginning partial operations at its fourth plant in October, with plans for full operations to begin in 2023. Upon completion, the CDMO will provide 604,000 liters of capacity (approximately 25% of global demand) at its Songdo, South Korea, headquarters. In addition, Samsung Biologics acquired 357,366 square meters (about 88.3 acres) of land in Songdo to construct a new Bio Campus facility, which will be 30% larger than the CDMO’s current Bio Campus.
Samsung Biologics has also expanded into the U.S. with its CDO facility in San Francisco, which launched in 2020 and has focused on offering clients based in or near the U.S. faster timetables for cell line development. The facility utilizes Samsung Biologics’ proprietary S-CHOice technology, which can develop high concentrations of monoclonal antibodies, reaching as high as twice the industry standard at 7.0 g/L.
“We now have three plants of roughly 30,000, 150,000, and 180,000 liters, respectively, all of which are running at almost full capacity, and phase one of a fourth 240,000-liter plant will come online in October 2022. Since 2018 we have also had a robust clinical development offering, and from 2021, Samsung Biologics has been performing fill and finish services in Korea for Moderna’s mRNA vaccine,” said Rim in a recent interview. “All of this has led to year-on-year sales growth of 35% over the last few years with operating income margins in the 30th percentile.”
With the expansion in both development and manufacturing capabilities, Samsung Biologics is capitalizing on its recent growth to pursue a broader strategy of offering end-to-end, full-service capabilities in a variety of areas of biologic medicine.