An Interview with Marc Studer

What prompted Samsung Biologics to invest in a dedicated ADC facility, and how does this align with current trends in the biopharmaceutical industry?

Samsung Biologics has continuously invested in its capabilities to address the evolving needs of the biopharmaceutical industry. With numerous large pharmaceutical companies and emerging biotech firms introducing ADC programs given its promising therapeutic potential, the company has strategically expanded into ADC development and manufacturing to better support client pipelines with reliable and integrated services.

ADCs, which combine monoclonal antibodies with cytotoxic payloads, require specialized handling due to their highly potent nature. To mitigate regulatory and cross-contamination concerns, Samsung Biologics built a dedicated ADC facility across from its main campus, ensuring streamlined operations while maintaining necessary segregation. This setup enhances efficiency while enabling the highest standards of containment and regulatory compliance.

Can you describe the key features of Samsung Biologics’ new ADC facility, particularly its reactor capacity and containment capabilities?

Our new four-story facility can accommodate a comprehensive range of ADC processes, from development and conjugation to final drug product (DP) formulation and fill-finish operations.

• Conjugation and Processing: Equipped with two manufacturing trains, the facility supports scale-up to 500 L using stainless steel and single-use systems. Manufacturing suites are designed to facilitate various ADC operations, employing appropriate purification techniques such as carbon filtration, chromatography, and tangential flow filtration. Advanced containment measures along with a dedicated facility design can maintain occupational exposure limits (OEL) as low as 5 ng/m³, ensuring safe handling of highly potent compounds. » INTERVIEW » 62 | | April 2025
• Fill-Finish Operations: After conjugation, the liquid bulk ADC travels just one floor up to a state-of-the-art filling line housed within the same building, ensuring minimal exposure and streamlined processing. For lyophilized products, the filling line is connected to a 40 square-meter shelf-capacity lyophilizer with LN₂ cooling. Liquid products can be directly transferred to stoppering and capping equipment for final container closure, which is followed by external vial washing. Once washed, vials are stored in an adjacent cold room before undergoing semi- or fully automated visual inspection. For products requiring packaging, a fully automated line within the same facility processes vials ranging between 2–100 mL, with serialization and aggregation implemented as necessary.

The facility also offers state-of-the-art laboratories for process development, manufacturing science and technology, and quality control analytics necessary for the entire ADC lifecycle. The integrated facility optimizes production efficiency, enhances quality control, and reduces logistical complexities often encountered in ADC development and manufacturing.

How does Samsung Biologics’ ADC service scope differ from its traditional antibody manufacturing, and what unique challenges does ADC production present?

Unlike traditional antibody manufacturing, ADC production involves conjugating highly potent small-molecule payloads to antibodies, requiring additional safety and containment measures. Specialized engineering controls and facility design are necessary when handling cytotoxic payloads and organic solvents, as well as for open handling, to protect personnel and ensure consistent product quality.

Samsung Biologics addresses these challenges through its ADC facility design, with advanced containment technologies, optimized workflows, and robust quality control measures for safe and efficient development and manufacturing. Additionally, stringent waste management protocols are in place for both solid and liquid byproducts to ensure a safe manufacturing environment.

What role does artificial intelligence play in Samsung Biologics’ approach to ADC development and manufacturing?

Artificial intelligence (AI) is increasingly being integrated into Samsung Biologics’ development and manufacturing processes, particularly for automated visual inspections. AI-implemented systems enhance defect detection by distinguishing between cosmetic and actual product irregularities, reducing false rejects and improving overall quality.

To support more precise, efficient, and high-quality ADC production, AI-powered process monitoring is also being considered to optimize conjugation parameters, enhance predictive maintenance, and streamline data analysis.

How is Samsung Biologics positioning itself to meet the growing demand in the global ADC market, which is projected to reach $27.37 billion by 2033?

Samsung Biologics is leveraging its expertise in large-scale biologics manufacturing to offer fully integrated ADC services, spanning conjugation, formulation, and fill-finish at a single site. This approach enhances operational efficiency, reduces supply chain complexities, and accelerates time-to-market for clients.

Furthermore, the company’s robust regulatory track record and global supply chain network further strengthen its ability to support biopharmaceutical companies in advancing their ADC programs from clinical development to commercialization.

How does Samsung Biologics plan to address common challenges in ADC manufacturing, such as premature payload release and immune-related side effects?

To mitigate the premature release of payloads, Samsung Biologics focuses on optimized conjugation chemistry and process controls, ensuring that linkers remain stable until reaching the intended target within the patient body. Advanced analytical techniques are used to verify linker stability and payload attachment throughout the manufacturing process, while precise control over formulation and filling conditions helps maintain ADC structural integrity and reduces the risk of aggregation and immunogenicity. Process improvements in drug loading and purification further enhance the safety and efficacy profile of ADC therapies.

With the ADC facility becoming operational in 2025, what are Samsung Biologics’ plans for expanding its ADC services and capacity in the coming years?

The initial phase of our ADC services will focus on conjugation, with DP capabilities expected by 2027.  With continuous demand for ADC therapies, Samsung Biologics is evaluating further expansion, including increased lyophilization capacity and enhanced fill-finish automation.

How does Samsung Biologics envision its role in advancing ADC therapy, and what innovations or technologies is it exploring for future ADC development?

Samsung Biologics is committed to developing ADC technologies and leveraging its expertise in antibody-based therapies to advance client projects. As ADC demand grows, the company is exploring new approaches to enhance therapeutic efficacy and manufacturing efficiency. One area of focus is bispecific ADC technology, which enables diverse mechanisms of action to address current treatment limitations and broaden therapeutic application.

Samsung Biologics is also closely monitoring industry advances for next-generation payloads that have potential to improve safety and efficacy. With capacity and expertise in biologics development and an integrated service model, Samsung Biologics is well-positioned to support clients with our ADC innovations.

Author Details 

Marc Studer,  Senior Director and Head of ADC/mRNA Operations, Samsung Biologics

Publication Details

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