Samsung Biologics, the world’s largest contract development and manufacturing organization by capacity, took time to focus on the development side of its business at the BioProcess International 2023 conference. At the event, held in Boston from Sept. 18 to Sept. 21, the CDMO discussed its proprietary platforms for drug discovery, cell line development, and process development. It also highlighted its capacity expansion and a new enhanced chemistry, manufacturing, and controls package.
Drug discovery is the beginning phase of drug development when potential new medicines are identified and optimized for further advancement. It encompasses the identification of candidates, synthesis, characterization, screening, and assays for therapeutic efficacy. Once a CDMO identifies a promising candidate, it undergoes further optimization to improve its therapeutic efficacy, safety, and manufacturability.
At BioProcess International, Samsung Biologics’ showcased its two drug discovery platforms: S-DUAL™ and DEVELOPICK™.
The S-DUAL™ platform is designed to produce high-yield bispecific antibodies. The platform facilitates chain pairing, the process by which bispecific antibodies can simultaneously recognize and bind to two different antigens or epitopes. According to Samsung Biologics, the platform has a 99% chain-pairing success rate. Its unique asymmetrical structure mitigates risks tied to chemistry, manufacturing, and control, and improves binding affinity among chains. This improved performance can amplify titer and purity.
Designed as a rapid developability assessment tool, DEVELOPICK™ systematically screens molecules at an early development stage to pinpoint candidates with the highest potential for progression to investigational new drug and biological license application stages. According to Samsung Biologics, it requires only 20 milligrams of material, enabling robust risk assessment for unsorted drug candidates within a month.
Cell Line Development
Post the drug discovery phase, cell line development is crucial for the production of biopharmaceuticals. At this stage a suitable cell line, which is a genetically identical type of cell, is developed and optimized for drug production. The objective is to establish a cell line that can produce the desired proteins and antibodies in high quantities and quality under defined conditions.
Samsung Biologics’ S-DUAL™ platform was the subject of a speaking session at BioProcess led by Janet Lee, Director of Cell Line Development at Samsung Biologics. The platform leverages glutamine synthase knock-out Chinese hamster ovary (CHO) cell line technology to exhibit improved titers reaching above 7 grams per liter for standard monoclonal antibodies. It also demonstrates enhanced cell viability, with over 90% viability at day 21 in a fed-batch study. This is well above the CDMO industry average of four to five months.
Following the establishment of a suitable cell line, process development is undertaken to ensure the scalable, reproducible, and cost-effective production of the biopharmaceutical. This phase involves optimizing the production process, including the cultivation of cells and the harvest and purification processes to ensure the final product meets the required quality standards.
Samsung Biologics’ process development platform S-Glyn™, is designed to modulate N-glycan, a potential critical quality attribute. It’s meant to optimize cell culture conditions and perform comparability studies and critical quality attributes to optimize the development process.
A key element of Samsung Biologics’ sessions at the BioProcess International conference was the company’s integrated CMC solutions. CMC encompasses a range of services aimed at optimizing the drug development process. Samsung Biologics now offers an enhanced CMC package that focuses on replacing or improving cell lines, processes, or formulations to enhance key features of the drug development project.
Broader CDMO Expansion
Samsung Biologics also discussed the construction of its fifth manufacturing plant at the conference. The CDMO broke ground on Plant 5 in March of this year, and it’s expected to be operational by April 2025.
The plant will augment Samsung Biologics’ manufacturing capability by 180,000 liters, bringing its total capacity to an industry-high 784,000 liters. This expansion is aligned with the burgeoning demand for outsourced manufacturing of biopharmaceuticals.
Samsung Biologics will invest more than 1.9 trillion South Korean won (approximately $14 billion) in the plant, part of a broader investment of 7.5 trillion won for Bio Campus II, a new facility that will be constructed on 360,000 square meters (about 89 acres) of land acquired by the company in July 2022.
Bio Campus II is envisaged as a hub for large-scale manufacturing and innovation. Besides hosting Plant 5, the campus will accommodate additional large-scale plants and an open innovation center.
In a parallel development, Samsung Biologics is broadening its global outreach with the inauguration of a regional office in New Jersey, United States. This initiative is aimed at enhancing communication and collaboration with clients based in the U.S. and Europe.
Samsung Biologics’ presence at the BioProcess International 2023 sheds light on its extensive plans, which are aimed at addressing the growing demand for both outsourced contract development and contract manufacturing organization services in the biopharmaceutical sector. The company’s platforms for drug discovery, cell line development, and process development, alongside ambitious capacity expansion plans for Plant 5 and Bio Campus II, reflect a multipronged strategic approach to meet industry demands.