Samsung Biologics: "Bispecific Antibody Development Time Cut by 3.5 Months"

Introduces fast-track development strategy at BIX 2026
Proposes cutting development time from 13 months to 9.5 months
Improves productivity by optimizing culture and purification processes

Samsung Biologics has showcased its contract development (CDO) capabilities in bispecific and multispecific antibodies, next-generation biopharmaceuticals. The company introduced its ability to optimize manufacturing processes for complex antibody structures and improve quality control systems, as well as a fast-track development approach that can cut the development timeline from 13 months to 9.5 months.

Lee Taehee, a managing director at Samsung Biologics, said on the 28th at BioPlus-Interphex Korea 2026 (BIX 2026), held at COEX in Gangnam-gu, Seoul, “Simply making minor modifications to existing monoclonal antibody processes is not enough to develop bispecific antibodies.” He stressed, “It is important to understand the structure and characteristics of the molecule and apply a development strategy suited to them.”

Lee Taehee, executive vice president at Samsung Biologics, speaks on “Beyond Complexity: Rapid Development of Bispecific and Multispecific Antibodies” at BioPlus-Interphex Korea 2026 (BIX 2026), held at COEX in Gangnam-gu, Seoul, on the 28th. Photo by Lee Seongmin.

Bispecific antibodies are designed to bind simultaneously to two different targets. They may offer therapeutic effects that are difficult to achieve with conventional monoclonal antibodies, but their complex structures make manufacturing and quality control challenging. Impurities can arise as protein chains come together, making it necessary to design processes suited to the characteristics of each molecule from the development stage onward.

Samsung Biologics applies molecule-specific chemistry, manufacturing, and controls (CMC) strategies throughout the entire process, from cell line development and culture to purification, formulation, and analysis. This includes adjusting protein-chain expression ratios during early-stage cell line development and optimizing culture medium components and process conditions to improve both yield and quality during cell culture.

The company also presented examples of process improvements. In one bispecific antibody development project, adjusting culture conditions reduced the fragmentation rate—the rate at which proteins break into smaller pieces—by about 34 percentage points while increasing antibody production by about 20%. In another case, the company reduced the proportion of protein aggregates by about 14 percentage points while maintaining production levels.

In a development project involving antibody proteins clumping together to form high-molecular-weight aggregates, the company optimized purification conditions and separation processes to reduce the aggregate proportion from about 50% to around 1%. It also presented cases in which purification methods tailored to the characteristics of impurities achieved purity levels of at least 98% and 97%, respectively.

Lee Taehee, an executive director at Samsung Biologics, gives a presentation titled "Beyond Complexity: Rapid Development of Bispecific and Multispecific Antibodies" at BioPlus-Interphex Korea 2026 (BIX 2026), held at COEX in Gangnam-gu, Seoul, on the 28th. Photo by Lee Seongmin.

Lee said, “Even molecules with the same format can have different characteristics in their key impurities.” He added, “It is important to understand the molecular structure and the characteristics of its impurities, and to develop a purification strategy suited to them.”

Alongside these process optimization technologies, Samsung Biologics has established an operating system that can shorten development timelines. The company is carrying out some cell line development and analytical work in parallel, rather than sequentially as before, and is working with its quality control (QC) department from the early stages of development to verify the suitability of analytical methods. The company said this approach can reduce risks associated with analytical method technology transfer and shorten the related timeline by up to three months.

The company has also developed its own master cell bank (MCB) manufacturing capabilities, which it uses to prepare for clinical drug production. By combining time-saving techniques used in individual processes with parallel development, Samsung Biologics presented a fast-track strategy that can reduce the development process—from vector construction for gene expression to submission of an Investigational New Drug (IND) application—from about 13 months to 9.5 months.

Lee stressed, “There is no single solution that works for every complex antibody.” He added, “It is important to apply an integrated strategy tailored to the characteristics of each molecule, from cell line development and culture to purification, formulation, and analysis.”

This content was produced with the assistance of AI translation services.