Samsung Biologics (207940) will launch a drug product (DP) service for antibody-drug conjugates (ADCs) in August next year. The move extends the company beyond contract manufacturing into contract development, including ADC-related platforms, and sets it up to compete with global contract development and manufacturing organizations (CDMOs) such as Switzerland's Lonza and WuXi XDC, an affiliate of China's WuXi Biologics.
Samsung Biologics has internally set a target of starting its ADC DP service in August next year, according to pharmaceutical and biotech industry sources on the 18th. The company will begin installing equipment needed to run the production line late this year and complete the fill-finish facility by the first quarter of next year. It plans to start the service in the third quarter after completing process validation and certification under good manufacturing practice (GMP) standards.
Samsung Biologics is moving into ADC fill-finish to offer an end-to-end service that runs from drug substance (DS) through to drug product. ADCs link antibodies to highly toxic drugs through a linker, which makes transporting the material difficult at the drug substance stage. Completing everything at a single plant — from drug substance production to the finished vials used at medical institutions — makes it easier to secure stability across the entire process, from manufacturing to storage and transport.
Lee Sang-myung, a vice president in charge of development at Samsung Biologics' CDO division, made a similar point at the J.P. Morgan Healthcare Conference in January this year. "Securing stability is a key challenge for ADCs," he said, adding that demand for ADC fill-finish services is growing as clients want their ADCs supplied as quickly and safely as possible, and from nearby locations.
For these reasons, global CDMOs are racing to expand their ADC fill-finish capacity. Lonza, the world's largest CDMO, announced in its July earnings release that it would expand the ADC fill-finish line at its plant in Stein, Switzerland. It is targeting 2030 for operation.
WuXi XDC, an affiliate of WuXi Biologics, also obtained GMP operating approval in August this year for an ADC fill-finish facility in Singapore. That came about two and a half years after it announced in March 2024 that it would make Singapore its first overseas production base outside China, in response to the U.S. Biosecure Act. The facility is reported to be capable of producing up to 8 million vials a year.
The rapid growth of the ADC market is another factor driving the global expansion race. According to the Korea Biotechnology Industry Organization, the global ADC market is expected to grow from $21 billion (about 30 trillion won) this year to $24.8 billion (about 35 trillion won) in 2027 and $28.5 billion (about 41 trillion won) in 2028. As of June this year, the number of newly approved ADC drugs each year has also been rising — none in 2023, one in 2024, five in 2025 and two in the first half of 2026, with six under review including AOCs. As ADC drug development and commercialization expand in oncology, CDMOs are being asked to bring a wider range of capabilities.
Samsung Biologics is also expanding its ADC-related technology platforms beyond drug substance and drug product manufacturing. It is jointly developing next-generation linker-payloads with Aimed Bio (0009K0), with the goal of combining them with a bispecific antibody platform to build a bispecific antibody ADC platform. The company is also broadening into next-generation antibody-conjugate therapeutics (AXCs), including antibody-oligonucleotide conjugates (AOCs) and antibody-peptide conjugates (APCs), which combine antibodies with peptides. An industry official said the strategy appears aimed at securing both production facilities and technology platforms in order to meet a wide range of client development and manufacturing needs.