With an agile and flexible, customer-centered CDO (contract development) service, we shortened the time from antibody drug candidate screening to investigational new drug application (IND) to eight months, about 20% shorter than the industry standard.
Lee Tae-hee, head of the antibody culture PD team (executive director) at Samsung Biologics, said this while introducing the company's CDO capabilities that accelerate new drug development at BioPlus-Interphex Korea 2025 (BIX2025), held at COEX in Gangnam-gu, Seoul, on the 16th.
On this day, Lee gave a presentation on the theme "Accelerating new drug development: From developability assessment to IND submission." Lee said, "Through early-stage developability assessment, a risk-based CMC (chemistry, manufacturing and controls) strategy, and parallel workflows, we reduced development complexity while maintaining quality." This session drew intense industry interest, with advance registration for its 100 seats closing early.
Samsung Biologics has launched nine platforms to shorten clients' development timelines. Starting in 2020 with the cell-line platform S-CHOice, it introduced S-Tensify, a platform that supports high-concentration biopharmaceutical development, and S-HiCon, a high-concentration formulation development platform.
Lee said, "Once we complete establishing our in-house master cell bank (MCB) within this year, the development timeline will be further shortened," adding, "Based on our accumulated track record (demonstrated results), we will work with clients to solve the difficult challenges they may face in the new drug development process."
Samsung Biologics' CDO business has continued its growth, winning a total of 146 contracts through the first half of this year. Recently, it also launched the Samsung Organoid service, which tests drug candidates using organoids (organ-like models), expanding into the early research-stage contract research organization (CRO) space. It has broadened its business as a contract research, development and manufacturing organization (CRDMO).
At this year's BIX2025, the company set up a solo booth for the second consecutive year. The company aims to secure a total production capacity of 1,324,000 liters (L) by 2032 and is expanding its business into various therapeutic modalities, including antibody-drug conjugates (ADC) and adeno-associated virus (AAV).