As the biologics market expands and therapeutic formats grow more complex, cell line development (CLD) must evolve to deliver greater speed and consistency alongside improved product quality. Samsung Biologics has responded with a next-generation CLD platform built on its S-CHOice® cell line, enhanced by transposase-mediated integration. Together with the afucosylated S-AfuCHO™ line and a high-throughput lectin assay for glycosylation profiling, the innovation accelerates development timelines, supports targeted glycoengineering, and reduces downstream risk. With over 80 stable cell lines developed and more than 38 investigational new drugs (INDs) supported, Samsung Biologics offers proven and flexible platforms for complex biologics. This article explores how the company’s integrated approach is helping biopharma partners streamline early development and achieve clinical and commercial success.
Meeting the Evolving Needs of Biologics Development
The global biologics market is expanding rapidly, with a projected compound annual growth rate of 8% from 2024 to 2030 due to rising demand for diverse therapeutic modalities, including monoclonal antibodies (mAbs), bispecific antibodies (bsAbs), Fc-fusion proteins, and other next-generation biologics.1 This accelerating growth brings with it heightened expectations for speed, scalability, and quality — placing greater pressure on development platforms to deliver high-performing cell lines faster and more reliably.
CLD has become a linchpin in this evolving landscape. With therapeutic programs growing more molecularly diverse and timelines from discovery to clinical entry being scrutinized, traditional random integration approaches to gene insertion often struggle to keep pace. Developers now expect more from CLD: not only high productivity and product quality but also effective tools that can fine-tune post-translational modifications and expedite timelines.
Samsung Biologics has responded to these demands with an advanced, integrated CLD platform anchored in its S-CHOice® cell line. With more than 80 stable cell lines developed and over 38 IND applications supported, the company has established a proven track record in molecule development. Notably, approximately 57% of projects have involved multispecific antibodies, fusion proteins, antibody-drug conjugates, and other advanced modalities, highlighting Samsung Biologics’ deep expertise with complex molecule types. To further meet client needs for speed, flexibility, and product tailoring, Samsung Biologics has expanded the S-CHOice® platform to include a suite of next-generation tools. The transposase system enables semi-targeted integration and accelerates timelines, S-AfuCHO™ enhances antibody-dependent cellular cytotoxicity (ADCC) via afucosylation, and S-CHOsient™ offers greater platform versatility.
These tools reflect a platform built for both performance and adaptability. Samsung Biologics’ CLD team supports a spectrum of programs — from high-yield mAbs to structurally complex bsAbs — with agility and scientific rigor. Internal studies have demonstrated how these innovations lead to improved titers, enhanced product quality, and reduced development timelines, particularly when transposase and S-AfuCHO™ are used in combination. Together, these tools provide clients with a foundation for successful biologics development from preclinical through commercial manufacturing.
Optimizing Productivity and Efficiency with Transposase Technology
Traditional CLD methods often rely on random integration of the gene of interest (GOI), a process that can present challenges for modern biologics development. Random integration can result in variable expression levels due to positional effects within the genome, where the gene inserts into transcriptionally inactive or unstable regions. This unpredictability requires extensive clone screening, prolongs development timelines, and introduces uncertainty around long-term stability and consistency.
To overcome these challenges, Samsung Biologics has adopted a transposase-based gene integration system within its S-CHOice® CLD and CHOZN platforms. The system uses a cut-and-paste mechanism that pseudo-targets GOI insertion into regions of open chromatin — areas of the genome that are transcriptionally active and likely to yield consistent, high-level expression. By facilitating reliable and efficient transgene integration, the transposase system minimizes positional effects and clone-to-clone variability.
Unlike traditional systems, the transposase method has no restrictions on gene size, allowing larger and more complex constructs to be delivered in a single transfection. Transfection recovery times are reduced, typically within seven to 10 days, and cells generated with the transposase system are often ready for upstream process development in as little as two months for mAbs and 3.5 months for bsAbs. These advantages make the platform particularly well-suited to structurally complex biologics.
The transposase platform has shown improved productivity and stability. In internal performance comparisons, the system delivered up to a seven-fold increase in product concentration at both the pool and clone stages compared to traditional random integration methods (Figure 1). Product purity is either maintained or improved across development milestones, as measured by capillary electrophoresis–sodium dodecyl sulfate (CE-SDS), size exclusion–high-performance liquid chromatography (SE-HPLC), and other analytical techniques.
Figure 1. Improvement in titer and quality from the S-CHOice® and transposase system
Clone stability is another noteworthy metric. Among the top-expressing clones evaluated, 97% remained stable through 60 population doublings, with 83% retaining more than 90% of their original productivity across that period (Figure 2). This level of consistency is needed for programs advancing into late-stage development and commercial manufacturing.
Figure 2. Clone stability track record of the transposase system
Performance has been documented across multiple molecule types. In one representative internal study, a mAb program using the transposase platform achieved significantly higher titers than random integration at both the screening and final selection stages. Additional studies involving bsAbs confirmed similar gains in productivity and purity, underscoring the platform’s effectiveness for more complex modalities.
Together, these results position transposase-enabled S-CHOice® development as a powerful platform for drug developers seeking faster timelines, better yields, and a more robust foundation for process scale-up.
Enhancing Effector Function With S-AfuCHO™
As biologics development increasingly turns toward immune-mediated mechanisms of action — especially in oncology — there is growing demand for antibodies that deliver enhanced effector function. One key strategy to achieve this is through afucosylation, a targeted glycosylation modification that significantly enhances ADCC.
ADCC is mediated through the interaction of an antibody's Fc region with the FcγRIIIa receptor on natural killer cells. The presence of fucose on the Fc-linked glycans reduces this binding affinity and consequently lowers ADCC activity. By removing fucose residues, antibodies exhibit improved receptor engagement and trigger more potent immune responses — a critical factor in the clinical efficacy of therapeutic antibodies targeting cancer and viral infections.
Samsung Biologics developed the S-AfuCHO™ platform to meet this growing demand for afucosylated antibodies with heightened ADCC. S-AfuCHO™ is an engineered derivative of the company’s S-CHOice® cell line, created through knockout of the FUT8 gene, which encodes the fucosyltransferase enzyme responsible for core fucosylation. The result is a stable, afucosylated CHO line that retains all the favorable growth and production characteristics of the parent S-CHOice® line, including robust viability, high titer, and long-term expression stability.
Critically, no further engineering is required following the FUT8 knockout to achieve the afucosylated phenotype. However, when used in combination with the transposase system, the S-AfuCHO™ platform can deliver even greater gains in productivity and quality, enabling shorter timelines and more consistent output of afucosylated antibodies.
Internal evaluations show that S-AfuCHO™ matches the production titer of S-CHOice®, achieving a 100% relative yield with no performance penalty. Antibodies expressed from the S-AfuCHO™ platform are confirmed to be completely fucose-free, resulting in a dramatic increase in ADCC activity. When benchmarked against antibodies produced using S-CHOice® or commercial reference products, S-AfuCHO™-derived antibodies consistently deliver higher ADCC responses across all tested concentrations (Figure 3).
Figure 3. Reduction in fucosylation and enhancement of ADCC activity through the S-AfuCHO™ platform
Given these characteristics, the S-AfuCHO™ platform is particularly well-suited for biologics where enhanced ADCC is a critical quality attribute (CQA), most notably in oncology and immune therapy programs. Samsung Biologics has validated its utility across internal test programs and anticipates broadening its impact as more partners seek tailored glycoengineering solutions.
By providing a scalable, high-performing cell line that enables effector function enhancement without sacrificing productivity or stability, S-AfuCHO™ presents a strategic advancement in the design and development of therapeutic antibodies.
Controlling Glycosylation Profiles With a High-Throughput Lectin Assay
Glycosylation is one of the most complex CQAs in drug development, with direct implications for pharmacokinetics, immunogenicity, serum half-life, and biological activity. Among the various glycan structures, sialylation — the addition of sialic acid to the terminal ends of glycans — plays a particularly important role in modulating molecular stability and therapeutic performance. Consistent and well-controlled glycosylation profiles are essential to the safety and efficacy of therapeutic proteins, especially as regulatory expectations for quality attributes evolve.
Historically, glycosylation analysis has relied on high-performance analytical techniques, such as mass spectrometry or chromatographic profiling, which offer high specificity but are often slow, resource-intensive, and sample-dependent for early-stage clone screening. These traditional assays typically require high concentrations of purified protein and are useful in later development stages — after clone selection decisions have been made.
To address this gap, Samsung Biologics developed and implemented a high-throughput lectin assay platform for rapid, early-stage glycan profiling with high specificity. Built on Octet® biolayer interferometry technology, the assay detects sialic acid levels through the binding of lectins — sugar-binding proteins that recognize specific glycan motifs — with high accuracy and minimal sample requirements.
This assay offers several key advantages over traditional methods:
High speed: Capable of analyzing 96 samples in 20 minutes.
Low sample concentration: Requires small volumes and works directly with harvest cell culture fluid.
No purification requirement: Enables real-time screening without additional preparation steps.
High specificity: Accurately quantifies terminal sialic acid modifications and distinguishes levels with high resolution.
The platform has been validated internally through comparative studies that show a strong correlation with traditional total sialic acid content analysis, as well as a high degree of consistency from the pool stage to the clone stage. This assay allows for large numbers of pools and clones to be screened early in the CLD process — improving the likelihood of selecting candidates with optimal glycosylation profiles before entering process development.
The assay has also proven useful for in-process monitoring. For example, it has been used to track sialic acid stability across multiple passages during in vitro cell aging studies, enabling a more complete understanding of glycan consistency over time. In some Fc-fusion protein programs, early profiling using the lectin assay has directly influenced clone selection, revealing differences in glycosylation patterns that were otherwise not seen in traditional screening.
While initially developed for sialylation, the assay has since been validated for additional glycan types, including fucosylation, galactosylation, and mannosylation, broadening its utility across a range of molecule classes and product quality goals.
By integrating this high-throughput assay into the CLD workflow, Samsung Biologics provides partners with a powerful tool to optimize glycan profiles from the outset — improving development efficiency, reducing the risk of downstream setbacks, and supporting regulatory compliance through better control of CQAs.
Shaping the Future of CLD With Samsung Biologics
The convergence of advanced gene integration, glycoengineering, and high-throughput analytics within Samsung Biologics’ S-CHOice® platform enables a comprehensive and forward-looking approach to CLD. Together, tools such as the transposase system, S-AfuCHO™, and the high-throughput lectin assay provide clients with a robust, flexible platform designed to overcome technical challenges as well as to accelerate development trajectories and improve clinical outcomes.
By using the transposase system for semi-targeted gene integration, drug developers can shorten development timelines — with cells ready for upstream development in two to 3.5 months, depending on the complexity of the molecule. The early productivity and stability of these pools shorten transition periods into process development, and the consistency achieved through targeted integration reduces the risk of performance drift later in the product life cycle.
In parallel, the S-AfuCHO™ platform empowers drug developers to build biologics with enhanced therapeutic potency, which is key for oncology and immune-targeting programs. By eliminating fucose residues from antibody Fc glycans, S-AfuCHO™ drives significantly greater ADCC activity while maintaining high titer and expression stability. These benefits are delivered without compromising the operational characteristics of the original S-CHOice® platform, enabling direct adoption with minimal adaptation.
Samsung Biologics’ high-throughput lectin assay allows partners to optimize and control glycosylation profiles earlier than traditional methods would allow. This timely insight into CQAs, such as sialylation, fucosylation, and galactosylation, supports tailored clone selection and process definition, mitigating extensive downstream troubleshooting and rework.
Importantly, the data generated through the CLD process are fully integrated into downstream development workflows. Clients routinely leverage Samsung Biologics’ analytics and cell line performance datasets to inform process development strategies, support comparability exercises, and satisfy regulatory expectations for quality and consistency.
Samsung Biologics’ CLD innovations have been validated across bioreactor scales and manufacturing facilities, ensuring that high-performing clones identified during development maintain their productivity and quality throughout tech transfer and scale-up. The proven scalability and reproducibility of the transposase-based platform help meet clinical or commercial supply goals without costly setbacks.
By offering a harmonized set of high-value tools and a collaborative development model, Samsung Biologics enables clients to reach key milestones more quickly, reduce development risk, and maintain control over complex biologics throughout their lifecycles.
Driving Client Success through Platform Innovation
Samsung Biologics continues to advance its cell line development capabilities to meet the growing complexity and urgency of biologics programs. Through ongoing innovation within its S-CHOice® platform, the company offers clients a scalable, flexible, and scientifically rigorous approach to generating high-quality, differentiated therapeutics.
Rather than treating innovation as a series of standalone upgrades, Samsung Biologics integrates tools like the transposase system, S-AfuCHO™, and the high-throughput lectin assay into a cohesive CLD framework that accelerates timelines, enhances product quality, and aligns tightly with downstream development and manufacturing.
As the biopharmaceutical landscape evolves, Samsung Biologics remains a proactive partner, empowering clients to navigate development more confidently, reduce risk, and bring novel therapies to patients faster.
Reference
1. Samsung Global Research Analysis. Mar 2024.
