An Inside Look at Samsung Biologics’ Cell Line Development Platform: S-CHOice® and S-CHOsient™

Cell line development is a critical step in the biopharmaceutical manufacturing process, involving the creation and selection of cell lines capable of producing therapeutic proteins, such as antibodies or vaccines. For contract development and manufacturing organizations, a robust cell line development platform is the foundation of productive partnerships with pharmaceutical companies that need to manufacture biologic drugs at scale.

“In a very real sense, the leading CDMOs today are innovators themselves. They develop and implement novel manufacturing solutions that address some of the most pressing problems facing drug developers,” said Daniel Buckley, lead scientist at CDMO Samsung Biologics, in a recent interview. 

“They have developed the specialized skills and expertise that are key to the successful development of complex molecules in the accelerated timelines required today, but are not practical for every drug developer to establish in-house.”

How Cell Line Development Works

The drug development process often starts with the selection of a suitable host cell, commonly Chinese hamster ovary cells, which are chosen for their similarity to human cells, their adaptability, and high-yield protein production potential. 

Scientists then introduce a gene of interest into these cells, which enables the cells to produce the desired protein. Cells are screened to identify those that exhibit high levels of protein expression and stability over time. The selected cell lines are then scaled up in bioreactors, where conditions are optimized for protein production on a larger scale.

Cell line development is meticulous and  requires precise control over various factors to ensure the production of high-quality biopharmaceuticals. It encompasses genetic engineering, selection techniques, and bioprocessing, all aimed at achieving high yield, purity, and functionality of the therapeutic protein.

Cell Line Development at Samsung Biologics

Samsung Biologics’ cell line development platform is designed to  streamlines the development process, from gene synthesis to the production of a stable cell line capable of expressing the desired protein at high levels.

The CDMO’s S-CHOice® platform integrates several key technologies and methodologies, utilizing Chinese hamster ovary cells equipped with glutamine synthaseknockout technology. The CHO-K1-based cell line development process central to the S-CHOice® platform is engineered for high performance, aiming to maximize the production titers and enhance cell viability — two critical factors in the efficient production of therapeutic agents.

It has the capability to produce concentrations of antibodies or other biologics exceeding 7 g/L for standard monoclonal antibodies, a figure that surpasses the industry average. The platform has also demonstrated enhanced cell viability of over 90% at day 21 in a fed-batch study, a testament to its optimized cell culture conditions.

A pivotal aspect of Samsung Biologics' approach to cell line development is the integration of the Beacon system, a sophisticated technology enabling precise single-cell cloning. This innovation is crucial for screening vast numbers of cells efficiently, improving the likelihood of identifying cell lines that yield high quantities of biologics while maintaining quality. The Beacon system streamlines the traditionally time-intensive and laborious process of cell selection.

In conjunction with the S-CHOice® platform, Samsung Biologics employs its S-CHOsient™ platform, a proprietary technology for transient gene expression. S-CHOsient™ plays a vital role in synthesizing the genetic components necessary for a cell to produce the desired antibodies, including facilitating the transfection process — where the essential genetic material is inserted into the cell. 

Further enhancing the platform's capabilities is the DEVELOPICK™ technology, designed for high-throughput screening to evaluate cell viability and quality. DEVELOPICK™ represents another layer of Samsung Biologics’ integrated approach, ensuring that only the most viable and high-quality cell lines proceed to the next stages of development and production.

The technology is a “rapid developability assessment platform that systematically screens molecules at an early development stage to identify the candidates with the best potential for advancement to [investigational new drug] and [biologics license application] filing,” said Buckley.

“Requiring as little as 20 milligrams of material, the assessment platform enables clients to conduct a robust risk assessment for unsorted drug candidates within a month, guiding them to the path of biotherapeutic development success. The flexible modular platform consists of a wide range of analytical methods that can be deployed in a high-throughput manner as needed for a given molecule.”

Samsung Biologics' comprehensive suite of technologies, from the S-CHOice® and S-CHOsient™ platforms to the innovative Beacon system and DEVELOPICK™ technology, illustrates the company's dedication to the rapid, efficient, and high-quality development of cell lines. Through its advanced cell line development services, Samsung Biologics is acceleratesing the pace at which new therapeutics are brought to market and definessetting new standards in the production capabilities of the biopharmaceutical industry.