Samsung Biologics to launch ADC drug product service in 2027

Samsung Biologics is preparing to launch an antibody-drug conjugate (ADC) drug product service in the first quarter of 2027, reflecting its efforts to more closely link drug development with downstream manufacturing.

Lee Sang-myung, vice president and head of business strategy at Samsung Biologics, speaks at a separate news conference with the Korean media held on the sidelines of the 44th J.P. Morgan Health Care Conference on Jan. 15. [SAMSUNG BIOLOGICS]

SAN FRANCISCO — Samsung Biologics is preparing to launch an antibody-drug conjugate (ADC) drug product service in the first quarter of 2027, reflecting its efforts to more closely link drug development with downstream manufacturing as it expands its contract development organization (CDO) operations.

A drug product service refers to the stage of development in which a drug substance is changed into a final dosage form suitable for manufacturing. This step is especially important for ADCs, as their chemical instability increases sensitivity to formulation-related issues that may affect development timelines and regulatory evaluation.

“Because ADCs involve attaching cytotoxic payloads to antibodies, stability can become a significant challenge,” said Lee Sang-myung, vice president and head of business strategy at Samsung Biologics, speaking at a separate news conference with Korean media held during the 44th J.P. Morgan Healthcare Conference on Thursday. “We found that customers have a strong need to produce the drug product as quickly as possible and in close proximity, typically stabilizing it through lyophilization for secure storage. This is why demand for ADC drug product services is particularly high.”

Samsung Biologics has already placed orders for the required equipment, with installation scheduled to begin toward the end of this year.

Since launching its CDO business in 2018, Samsung Biologics has secured a cumulative total of 164 development contracts, including five ADC-related projects, resulting in 49 investigational new drug approvals. The company currently operates nine proprietary CDO technology platforms covering multiple stages of drug development, ranging from developability assessment and cell line engineering to complex molecule optimization.

Its first proprietary platform, the S-CHOice cell line platform, has recently been upgraded through the introduction of a new vector and a newly developed mother cell line. The upgrade has improved productivity, increasing antibody titers from approximately 7 grams (0.2 ounces) per liter to as high as 13 grams per liter.

“Flexibility and speed have always been core competitive strengths for Samsung Biologics,” Lee said. “Our goal is to provide an end-to-end drug development life cycle so that customers can rely on a single partner from early development through clinical manufacturing.”

Through the integration of its CDO platforms, Samsung Biologics has reduced development timelines for monoclonal antibodies from around 11 months to nine months, and for bispecific antibodies from 13 months to 11 months. For ADCs, the company said its average timeline to drug substance production is approximately 14.5 months through integrated antibody and conjugation development.

Lee Sang-myung, vice president and head of business strategy at Samsung Biologics, speaks at a separate news conference with the Korean media held on the sidelines of the 44th J.P. Morgan Health Care Conference on Jan. 15. [SAMSUNG BIOLOGICS]

Lee also outlined plans for the Samsung Organoid platform, part of Samsung Biologics’ contract research organization business, which uses patient-derived artificial organ models to screen anticancer drug candidates.

Organoids have gained attention as a potential alternative to certain forms of animal testing, as the U.S. Food and Drug Administration has increased openness to nonanimal testing methods. Samsung Biologics aims to expand its organoid library to at least 500 models, with longer-term plans to exceed 1,000 models.

“Our first objective is to evaluate drug efficacy by examining how treatments perform across different patient-derived tumor types and disease stages,” Lee said, noting that regulatory guidelines in this area are still evolving. “There is also growing discussion around the potential for organoid-based approaches to partially replace traditional preclinical studies. In that context, organoids can be used to assess toxicity by measuring cell death following drug exposure.”

BY LEE JAE-LIM [lee.jaelim@joongang.co.kr]