Samsung Biologics is planning to start offering a service for antibody-drug conjugate (ADC) drugs in the first quarter of 2027. This move is part of the company’s efforts to connect drug development more closely with manufacturing, as it grows its contract development organization (CDO) business.
A "drug product service" is when a drug is turned into its final form, ready for production. This is especially important for ADCs because they are chemically unstable, and small changes in their formulation can affect the development process and regulatory approvals. Samsung Biologics has already ordered the necessary equipment, which will be installed later this year.
Since starting its CDO business in 2018, Samsung Biologics has secured 164 development contracts, including five related to ADCs, and has helped get 49 new drugs approved. The company currently runs nine different CDO technology platforms that cover all stages of drug development, from early assessments to optimizing complex molecules.
One of its main platforms, the S-CHOice cell line platform, was recently upgraded, improving the production of antibodies. This upgrade increased antibody production from 7 grams per liter to 13 grams per liter.
Samsung Biologics aims to offer a full range of drug development services, from early research to manufacturing, to help customers speed up the process. By integrating its platforms, it has already shortened development timelines for certain drugs, such as monoclonal antibodies and bispecific antibodies, and aims to do the same for ADCs.
Executive Statement
According to Lee Sang-myung, vice president and head of business strategy at Samsung Biologics, because ADCs involve attaching cytotoxic payloads to antibodies, stability can become a significant challenge. They 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.