Contract development and manufacturing organizations have become integral to the pharmaceutical industry ecosystem. CDMOs partner with drug makers to provide end-to-end services that include everything from preformulation, stability studies, preclinical and clinical trial materials, scale-up, and commercial production.
Increasingly, pharmaceutical companies of all sizes are relying on CDMOs that can accelerate the drug development process, provide cost savings and scalability, and ensure regulatory compliance. Samsung Biologics has emerged as a leader in the CDMO sector, with an expertise in monoclonal antibodies and a growing portfolio that’s expanded into areas such as bispecific antibodies, mRNA vaccines, and antibody-drug conjugates.
The company relies on proprietary platforms DEVELOPICK™ and S-CHOsient™ to further enhance and optimize the drug development process, identifying promising candidates at early stages of development and producing high-purity batches of the molecules needed to produce effective biopharmaceuticals.
“Through these new development technologies, we provide early insight and ensure higher yield of molecules, ultimately enabling clients to reach commercialization much more efficiently,” said John Rim, President and CEO at Samsung Biologics, in a statement when the company announced the release of DEVELOPICK™ in 2022.
DEVELOPICK™ and S-CHOsient™
DEVELOPICK™ is a rapid developability assessment platform that provides early insight and selection guidance to optimize efficiency in drug development. It was designed to require only 20 milligrams of material and can deliver results in just one month, showcasing efficiency and systematic scoring to guide optimal decision-making.
“An early-stage assessment tool can mitigate development risk and help minimize scale-up risk by facilitating the identification of potential issues — as well as informing the development of strategies to address them — before those issues become major problems,” wrote Samsung Biologics’ Derrick Katayama, lead scientist in formulation development, and Heonchang Lim, director of formulation development, in a recent white paper.
“This process also is conducive to developing a more effective drug product. Samsung Biologics continues to collaborate with its partners to improve the DEVELOPICK™ platform with each partnership and each project.”
S-CHOsient™ is a transient expression platform designed for the early generation of molecules of interest. It demonstrates high productivity and quality comparable to other commercial platforms, with a higher titer performance across modalities. The platform streamlines gene synthesis, vector construction, transfection, culture, harvest, purification, and analytics.
The Expanded Role of CDMOs in Drug Development
In recent years, CDMOs have shifted from mere service providers for manufacturing mature pharmaceuticals to leaders in the drug development process.
CDMOs can provide expertise beyond the manufacturing process, including early-stage testing and development and commercial launch. The customer base has shifted from mainly large pharmaceutical companies to now include smaller biotech firms. There’s a need for CDMOs to integrate early in the drug development and manufacturing processes of these companies, as there is an increased industry focus on preclinical research and clinical trial services. This evolution reflects the sector’s transition from a traditional volume-first business model to a more diversified and technologically advanced approach.
“While speed to market remains critical for nearly all activities, the industry is increasingly focused on maximizing the effectiveness of early-stage candidate assessments to predict a given molecule’s chances of success prior to investing heavily in that molecule,” wrote Katayama and Lim.
“To this end, Samsung Biologics created DEVELOPICK™, a rapid developability assessment platform that systematically screens molecules to identify candidates with the best potential for advancement to Investigational New Drug (IND) and Biological License Application (BLA).”
The role of CDMOs in the pharmaceutical industry is transformative and growing. As evidenced by platforms like Samsung Biologics’ DEVELOPICK™ and S-CHOsient™, these companies are not only accelerating the drug development process, but also bringing in new technological advancements and innovation. The future of drug development and manufacturing will rely heavily on the technological prowess and strategic capabilities of CDMOs, as companies like Samsung Biologics have become indispensable partners in the pharmaceutical industry.
“Our expanding partnerships with global leading pharmaceutical companies and a thriving sales backlog reflect the trust our clients place in us and our capabilities,” said Rim in a press release detailing the company’s Q3 2023 financials, which include over 1 trillion South Korean won (roughly $758 million) in consolidated revenue for the quarter. “Looking ahead, our expansion plans, including the construction of the [antibody-drug conjugates] facility and Plant 5, will meet the increasing market demand and support our clients’ needs for both capacity and business diversification.”