Samsung Biologics Launches ExellenS™ Framework to Standardize and Accelerate Global Biomanufacturing
Samsung Biologics a global leader in contract development and manufacturing (CDMO) services, has introduced ExellenS™, an optimized manufacturing framework designed to elevate efficiency, consistency, and scalability across its global biomanufacturing network. The new framework marks a major milestone in the company’s ongoing effort to streamline operations, strengthen quality standards, and deliver faster and more predictable outcomes for clients worldwide.
Developed from Samsung Biologics’ deep experience in plant design, digitalization, and operational excellence, ExellenS™ serves as a comprehensive system that standardizes equipment, processes, and functional specifications throughout all production sites. This uniformity ensures that every facility operates with the same precision and reliability—resulting in high-quality, reproducible outputs and faster tech transfers that accelerate regulatory approvals and time-to-market for biopharmaceutical products.
A Framework Rooted in Four Pillars of Excellence
ExellenS™ builds upon Samsung Biologics’ four foundational pillars—client satisfaction, operations, quality, and people expertise. These principles have long guided the company’s growth and success as a pure-play global CDMO. By embedding standardization, simplification, and scalability into every layer of manufacturing, Samsung Biologics aims to provide clients with unmatched reliability and flexibility in bringing life-saving therapies to patients worldwide.
“ExellenS™ reflects our established and unmatched competence in on-time project delivery and manufacturing excellence,” said John Rim, President and CEO of Samsung Biologics. “It reinforces consistent execution and outcomes across our plants and serves as a blueprint for scalable, optimized, and standardized operations as we continue to build new facilities and expand our global portfolio.”
Optimized Design for Consistent and Predictable Results
At the heart of ExellenS™ is an integrated design approach that incorporates Functional Design Specifications (FDS) across all plants. This ensures standardized bioreactor configurations, automation systems, and process equipment while maintaining flexibility for continuous innovation and tailored upgrades to manufacturing execution systems (MES).
Samsung Biologics has created a unified design model that balances consistency with adaptability. This approach minimizes risks associated with variability and deviation while maintaining the ability to adopt emerging technologies and enhance process efficiency. The result is a manufacturing environment that delivers predictable, high-quality results regardless of plant location—ensuring every client benefits from the same industry-leading standards.
Accelerating Speed to Market
One of the defining advantages of the ExellenS™ framework is its ability to accelerate speed to market. By ensuring system and process equivalency across all facilities, Samsung Biologics helps clients achieve faster regulatory approvals and smoother global tech transfers.
Standardized systems reduce downtime between production runs and minimize risks during scale-up, while harmonized operations allow for agile technology transfers and on-time product launches. For clients, this means shorter development timelines, enhanced regulatory confidence, and reliable manufacturing continuity—critical factors in a highly competitive biopharmaceutical landscape.
Through ExellenS™, Samsung Biologics is also strengthening its global regulatory readiness, enabling clients to navigate complex compliance environments with greater ease and consistency.
Building Resilience Through Standardization
In an era where supply chain stability and risk mitigation are paramount, ExellenS™ offers built-in resilience through standardization. The framework enhances supply chain continuity by supporting dual-sourcing and multi-plant production, ensuring uninterrupted manufacturing even in times of disruption.
Unified digital platforms integrate real-time monitoring, data analytics, and automation, enabling Samsung Biologics and its partners to respond quickly to global challenges with agility and scale. Replicated processes, uniform equipment, and minimized variability between plants make it possible to conduct rapid technology transfers and seamless scale-ups across regions.
Integrated IT systems also play a critical role in ensuring regulatory compliance, traceability, and audit readiness, further reinforcing client confidence and operational transparency.
“ExellenS™ defines how Samsung Biologics executes our overarching mission to help clients improve and extend lives,” added CEO John Rim. “It is the culmination of years of innovation, investment, and dedication to our partners. Through ExellenS™, we provide clients the confidence and flexibility they need to advance their therapies and deliver hope to patients around the world.”
Expanding Global Capacity and Capabilities
Samsung Biologics currently operates five state-of-the-art plants with a combined total biomanufacturing capacity of 784,000 liters, making it one of the largest CDMOs in the world. The company plans to expand capacity further through 2032, with additional developments underway at Bio Campus II, home to Plant 5, which became operational in April 2025.
The company’s growth strategy includes not only capacity expansion but also portfolio diversification. Samsung Biologics operates a dedicated facility for the development and manufacturing of antibody-drug conjugates (ADCs), one of the fastest-growing segments in biopharma. It also continues to enhance its capabilities in multispecific antibodies, fusion proteins, and mRNA therapeutics, reflecting the industry’s shift toward advanced and personalized medicine.
A Global Network for Global Clients
Beyond manufacturing, Samsung Biologics maintains a global presence to serve its diverse client base efficiently. The company operates commercial offices in Korea, the United States, and Japan. Samsung Biologics America supports clients across the U.S. and Europe, while its Tokyo sales office caters to the broader Asia-Pacific (APAC) region.
These regional offices allow for close collaboration and real-time client engagement, ensuring that global operations are supported by local expertise and responsiveness.
Commitment to Quality, Sustainability, and Future Growth
Samsung Biologics’ success has been built on a foundation of operational excellence and quality assurance. The introduction of ExellenS™ further solidifies that reputation, ensuring that clients receive consistent, high-quality biomanufacturing services regardless of project scale or location.
The company remains committed to on-time, in-full delivery of products that meet the highest standards of safety and efficacy. In parallel, it continues to pursue sustainable business practices—from energy-efficient operations to responsible sourcing and digital innovation—supporting the broader goal of improving global health while reducing environmental impact.
With ExellenS™, Samsung Biologics sets a new industry benchmark for standardization and scalability in biologics manufacturing. The framework not only strengthens the company’s position as a trusted global CDMO partner but also underscores its long-term vision: to empower biopharma innovators to deliver transformative therapies faster, more efficiently, and more reliably than ever before.
