Validating multiproduct biologics facilities is a regulatory requirement and key factor in ensuring product quality and patient safety. However, increasing molecular diversity, evolving technologies, varying product scales, and stringent regulatory expectations have made the validation process more complex. A successful validation strategy must be comprehensive and efficient to enable robust testing of equipment and facility systems under representative operational conditions. Drawing on extensive experience bringing four large-scale biologics plants online, Samsung Biologics has developed an innovative validation framework that accelerates facility readiness while ensuring compliance and quality. This strategy, designed for scalability, is now being applied to Plant 5 at the company’s second Bio Campus. It offers valuable insights for contract development and manufacturing organizations (CDMOs) seeking to optimize their validation processes.
Setting New Standards for Biomanufacturing Validation
The increasing complexity of biopharmaceutical manufacturing is driven by several industry trends, particularly the evolving demand for multiproduct biologics production facilities. Rising molecular diversity, stringent regulatory expectations, and the growing reliance on outsourcing partners are reshaping how CDMOs operate.
CDMOs must now accommodate multiple technologies, varying product scales, and diverse expression systems and dosage forms. Production platforms must be flexible enough to support client- and product-specific needs at all stages of development and commercialization while mitigating cross-contamination risks. Additionally, the adoption of quality-by-design principles is reshaping validation and risk management strategies.
Samsung Biologics has extensive expertise in constructing and launching large-scale biomanufacturing facilities. Over the past 14 years, the company has designed, built, and validated five biologics manufacturing plants, each equipped with bioreactors capable of supporting a broad range of production scales. These facilities have been brought online at an unprecedented pace, with groundbreaking to full completion taking three years at most.
Plant 5, the first facility constructed at Samsung Biologics’ Bio Campus II, marks a new milestone in rapid facility deployment. With a production capacity of 180,000 L (12 × 15,000-L bioreactors), this plant is engineered for seamless process integration, advanced automation, and sustainability. Construction began in early 2023, and partial operations began in April 2025, making it the fastest construction — just 24 months — among all plants in Samsung Biologics to date.
Leveraging insights from the construction of its first four plants, Samsung Biologics implemented a robust validation strategy for Plant 5. This strategy included a structured set of validation procedures and master plans to ensure consistency, operational efficiency, and regulatory compliance. A rolling execution approach accelerated project timelines while reducing risk. The validation innovation team met increasing customer demand and facilitated the rapid expansion of high-quality, flexible manufacturing capacity.
Figure 1. Samsung Biologics’ Plants
The Validation Imperative for Multiproduct Facilities
Effective validation of multiproduct biologics facilities is a regulatory necessity and fundamental to ensure product quality and patient safety. Given the complexity of producing diverse drug substances and products across multiple scales and technologies, facility validation must be rigorous and adaptable.
A well-executed validation strategy ensures that a facility’s design effectively mitigates the risks inherent in multiproduct manufacturing. The strategy should address the challenges associated with varied equipment, process technologies, and operational scales.
Comprehensive facility validation requires a structured and concise approach to testing GMP systems at their full operational range during start-up. This strategy must also validate key aspects of each facility to ensure they meet CGMP requirements:
Infrastructure and facility systems: The system design, utilities, and environmental controls must be validated to ensure they are appropriate for intended use according to approved user requirement specifications.
Process equipment and controls: GMP process equipment, as well as associated controls and analytics, must be validated to ensure they meet operational and process requirements.
Packaging, labeling, and storage: Equipment and processes must be validated to ensure product integrity, stability, and traceability.
Documentation and data integrity: Documentation and data must be validated to ensure compliance with regulatory standards for record-keeping, audit trails, and quality assurance.
For multiproduct facilities, validation success is achieved by balancing compliance with operational efficiency. A streamlined yet thorough validation approach minimizes risk while ensuring the facility maintains high throughput, adaptability, and regulatory adherence without unnecessary delays.
A Smart, Standardized Approach to Validation
Samsung Biologics has developed a structured validation strategy that ensures consistency, efficiency, and regulatory compliance across its facilities. This approach is built on well-defined validation procedures and master plans that standardize user requirements across similar equipment, streamlining the transition from design to validation. By implementing a phased execution or rolling validation approach, the company effectively manages project timelines and budgets, ensuring that each phase only begins after all necessary prerequisites are met.
A key factor in expediting the GMP readiness of Plant 5 was the concurrent execution of construction and validation activities. Samsung Biologics commenced equipment testing upon their receipt at Bio Campus I. The change control process was then leveraged once dedicated manufacturing space became available, so the validated equipment could be seamlessly transferred to Plant 5 for final installation with minimal operational testing. This process enabled faster deployment while maintaining quality and compliance. By mapping interdependencies across the engineering and validation processes while employing a phased execution strategy, Samsung Biologics significantly shortened capital project timelines. For instance, engineering runs in Plant 5 were able to commence five months earlier than in Plant 4A, with an early launch of the media preparation process before the formal completion of the cell culture area. Across its facilities, the company has achieved substantial time savings, with validation for Plant 5 completed in a fraction of the time for plants at Bio Campus I.
A crucial component of Samsung Biologics’ validation strategy for Plant 5 is the comprehensive integration of advanced automation and digital processes in plant operations, including the transition from programmable logic controllers (PLCs) to the DeltaV distributed control system (DCS) for the majority of drug substance manufacturing processes, adoption of paperless validation, and enhanced data integrity testing. Traditional PLC-based automation is well-suited for standalone unit operations, such as chromatography skids, that require rapid control responses. However, in a multiproduct facility with diverse and evolving production requirements, PLC-based systems require frequent upgrades, increasing costs, complexity, and technical support demand. Unlike PLCs, DeltaV DCSs offer a fully integrated automation framework that supports complex, interconnected processes with multiple control loops. While the upfront investment is higher, a DCS provides long-term cost savings, simplified process modifications, and greater operational efficiency. Additionally, PLCs often rely on proprietary vendor-specific libraries, requiring external technical expertise for software updates. They need multiple third-party databases to manage alarms, batch records, advanced controls, and system communications, creating potential data silos and adding compliance risks. In contrast, DeltaV DCS consolidates all automation functions into a single, standardized platform, allowing in-house administrators to efficiently make configuration changes. This reduces the reliance on vendor-specific expertise, which in turn minimizes compliance risk and improves overall system performance.
Figure 2. The Transition of Drug Substance Manufacturing Operations from PLC to DeltaV DCS
To further enhance compliance and operational efficiency, Samsung Biologics adopted a paperless validation solution for consistent execution. This digital approach reduces the risk of human error and ensures real-time data accuracy, version control, and automated tracking of changes for full traceability. Standardized documentation further improves cross-functional collaboration, while digitalization strengthens data integrity, regulatory compliance, and operational transparency. Together, these innovations position Plant 5 as an example of an efficient and scalable validation model in biologics manufacturing.
Optimizing Validation: Lessons Learned and Best Practices
With the construction and validation of each new facility, Samsung Biologics gained valuable insights into accelerating the timeline for safe and compliant plant operations. One key lesson was the importance of early and active engagement with clients to fully understand their process requirements. By incorporating these considerations into the validation strategy from the outset, the company ensures alignment between facility capabilities and client needs, optimizing efficiency and reducing delays.
Another critical improvement has been the adoption of a phased facility release approach, allowing for earlier release of key manufacturing support areas, such as media preparation and glassware washing, as well as upstream processing areas. By bringing these areas online sooner, engineering runs for technology transfer can begin earlier, shortening the overall timeline to achieve full facility start-up.
Multiplant qualification also played a vital role in streamlining validation. For Plant 5, equipment qualification was conducted at Bio Campus I while construction was still underway, maximizing operational efficiency. This approach was made possible through CGMP-compliant change control strategies that minimize risk and unforeseen issues. The early evaluation of planned equipment modification and implementation enabled seamless equipment relocation. Additionally, the transport of materials between Bio Campus I and Bio Campus II was validated in the early phase of the capital project, allowing Bio Campus I to provide essential support during the start-up phase for Bio Campus II.
Beyond these large-scale improvements, numerous refinements in validation procedures developed during the construction and validation of Plants 1 to 4 contributed to greater efficiency. Streamlining test protocols, eliminating redundant validation steps, and proactively addressing bottlenecks enhanced both agility and quality. For instance, constructing a dedicated storage space for incoming equipment and test materials improved operational readiness, reducing delays in equipment deployment.
Collaboration with vendors has been another crucial factor in accelerating validation. By leveraging vendor testing capabilities, Samsung Biologics minimized delays and reduced on-site validation efforts. The company’s validation experts worked closely with vendors to align the scope and content of the test protocols, ensuring they met all installation and operation qualification requirements. Samsung Biologics’ validation experts executed factory acceptance tests for Plants 3 and 4, but the vendors were responsible for validation execution for Plant 5, which allowed the company to focus on critical oversight in the review and approval to ensure that testing protocols and reports met the requirements. This shift streamlined validation workflows and allowed for faster facility readiness while maintaining the highest standards of compliance and operational excellence.
Building a Scalable, Future-Proof Validation Model
Samsung Biologics has faced the challenges in maintaining validation consistency across multiple plants. The plants at Bio Campus I each followed distinct validation plans that reflected the company’s evolving maturity in validation processes. As a result, transferring products between plants often required additional in-depth validation assessments and, in some cases, supplementary validation testing at the receiving facility to ensure compliance and process continuity.
To address these challenges, Samsung Biologics developed a comprehensive validation strategy for Plant 5, the first of four new plants planned for Bio Campus II. This strategy eliminates the internal technology transfer inefficiencies encountered at Bio Campus I by establishing a standardized approach for all Bio Campus II plants. By implementing a common validation framework, the company is enhancing consistency across facilities, streamlining validation execution, and ensuring seamless product transfer. This approach also increases operational flexibility, enabling better capacity management to meet dynamic production demands. Ultimately, this unified validation strategy is well-positioned to drive long-term operational success across Samsung Biologics’ growing manufacturing network.
Key elements of Plant 5’s validation framework — paperless validation, comprehensive integration, the transition of manufacturing operations from PLC- to DeltaV DCS–based controls, strategic phased facility release, and the implementation of a multiplant qualification strategy that leverages change control processes — offer valuable insights for CDMOs across the industry. By integrating these best practices, CDMOs can establish optimized validation strategies that balance compliance, efficiency, and scalability. This, in turn, enhances patient safety while supporting the cost-effective production of advanced biologics and next-generation therapies.
Driving the Future of Validation Through Automation and AI
With plans to construct three additional plants as part of Bio Campus II, the start-up of Plant 5 presented a unique opportunity in enhanced facility validation. Samsung Biologics developed a long-term validation strategy designed for deployment across multiple manufacturing sites. As new facilities come online within Bio Campus II, Samsung Biologics will apply the lessons learned from Plant 5 to refine and standardize validation processes across the facilities in its future manufacturing network.
Samsung Biologics remains committed to continuous innovation in validation, which balances regulatory compliance, client needs, process and technology transfer requirements, and operational agility. The company is making significant investments in automation and digitalization to enhance efficiency while adapting to evolving regulatory expectations.
Data integrity, data management, and process integration are key. Samsung Biologics is well-positioned to leverage advances in AI, machine learning, and automation in a validated manner. The next phase of digital transformation will likely involve the full integration of biologics manufacturing data management systems with paperless validation, further optimizing compliance, streamlining workflows, and improving resource allocation to expedite capital project execution.
At the same time, Samsung Biologics is continuously evaluating regulatory updates and industry standards to refine its validation approach. The company has expanded into new modalities by opening its dedicated antibody-drug conjugates facility this March, which further reinforced its commitment to driving ongoing enhancements to validation strategies and capabilities to meet the unique requirements of next-generation manufacturing processes. A risk-based approach to validation has become integral to Samsung Biologics’ operations, allowing the company to proactively identify and mitigate risks throughout the product life cycle while supporting the diverse and evolving needs of its clients.