Key Findings
Samsung Biologics has developed a tailored CMC capability for bispecific antibodies that optimizes the entire production sequence from cell line development to structural analysis. By implementing a process design strategy customized to the properties of each molecule, the company has shortened the timeline from cell line development to the filing of an investigational new drug (IND) application by approximately 27%, reducing the period from 13 months to 9.5 months.
Technical Details
The platform covers six formats, including fusion proteins and symmetric and asymmetric bispecific antibodies. Technical optimizations were applied across several stages:
- Cell Line Development: The company controls the expression ratio of protein chains to minimize mispaired products and screens for superior cell lines to improve productivity and quality.
- Cell Culture: Optimization of growth medium and culture conditions resulted in a 34% reduction in protein fragmentation and a 17% reduction in aggregation.
- Purification: A customized process for removing impurities similar to the target molecule achieved a final purity exceeding 98%.
- Workflow: The company utilizes stability testing technology and a parallel processing strategy to minimize waiting times between development steps.
Background & Context
The technology was presented by Lee Tae-hee, senior vice president and head of the antibody cell purification process development team, at Bio Plus Interphex Korea (BIX Korea) 2026 on October 28 at COEX in Seoul. Bispecific antibodies target two antigens simultaneously but possess complex molecular structures that make them susceptible to aggregation, fragmentation, and protein mispairing compared to monoclonal antibodies.
Significance & Outlook
Samsung Biologics intends to use this platform to expand its presence in the contract development organization (CDO) market, specifically targeting biologics that are technically difficult to develop. According to Lee, an integrated CMC strategy is necessary because simply modifying existing monoclonal antibody processes is insufficient to resolve the complexities inherent in bispecific antibody development.
Source: https://en.sedaily.com/finance/2026/10/28/samsung-biologics-unveils-custom-bispecific-antibody
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