Generative AI (GenAI) is increasingly transforming the biopharma industry across functions as diverse as regulatory compliance, quality assurance, and operational efficiency. Samsung Biologics’ approach to AI demonstrates how the technology enhances these areas to drive innovation and continuously align with best practices.
Unlocking AI Potential in Biopharma Operations
The biopharmaceutical industry operates within a stringent regulatory framework, requiring meticulous adherence to compliance standards to ensure the quality, safety, and efficacy of drug products. This includes the rigorous development and documentation of standard operating procedures (SOPs) and the management of vast records necessary for good manufacturing practice (GMP) compliance. For contract development and manufacturing organizations (CDMOs), this process is further intensified by specific client due diligence requirements and frequent audits. Maintaining comprehensive documentation and being inspection-ready are non-negotiable.
Traditional methods, such as manually sifting through extensive internal databases to locate and verify records — whether for SOPs, deviations, corrective and preventive actions (CAPAs), or change control (CC) — are time-intensive and prone to delays. These inefficiencies underscore the urgent need for advanced solutions that streamline operations and ensure seamless compliance.
Artificial intelligence (AI)-driven platforms present a transformative opportunity to optimize operations and stay ahead of regulatory expectations. By enhancing inspection readiness and operational workflows, AI can bolster regulatory compliance, mitigate risks, and deliver significant benefits beyond compliance. These include increased productivity, reduced operational costs, and improved service quality. In an industry where precision is paramount, AI offers a competitive edge by optimizing processes and addressing long-standing operational challenges.
Pioneering AI-Driven Transformation at Samsung Biologics
Recognizing AI’s transformative potential, Samsung Biologics identified its application to the bioregulatory industry as a strategic imperative. This commitment led to the development of a cutting-edge AI platform designed to streamline processes and foster innovation across the company’s operations.
Samsung Biologics leveraged the extensive expertise of the broader Samsung Group, particularly Samsung SDS, a leader in digital transformation and cloud services. Building on Samsung’s generative AI model (SR-LLM), the platform incorporates Brity Automation and retrieval-augmented generation (RAG) technology. This robust combination powers a customized AI solution that provides natural-language responses to user queries while utilizing a biopharma-specific glossary for accurate translation and context. Functionally akin to ChatGPT, the platform is uniquely tailored to the demands of the biopharmaceutical industry.
Seamlessly integrating into Samsung Biologics’ existing infrastructure, the AI platform enables the rapid collection and analysis of data from multiple sources. This capability supports better decision-making, proactively identifies improvement opportunities, and ensures swift responses to operational challenges. By significantly minimizing the risk of human error, the platform enhances product quality and ensures on-time delivery — key factors in fostering trust with clients and maintaining a competitive edge in the market.
The implementation of this AI-driven solution marks a transformative milestone in Samsung Biologics' journey toward digital excellence. Positioned at approximately stage 2.5 in its digital transformation trajectory, Samsung Biologics is progressing steadily through the pathway: from digital initiation (stage 1) and digital islands (stage 2) to establishing robust digital connections (stage 3) and, ultimately, achieving complete digital transformation (stage 4). This forward momentum underscores Samsung Biologics' leadership in the biopharmaceutical sector, setting the stage for sustained growth and innovation.
Figure 1. 4 Stages of Digital Transformation
Enhancing Regulatory Readiness with Advanced AI
Samsung Biologics’ AI platform represents a leap forward in streamlining interactions with clients and inspectors, particularly in the areas of quality and regulatory compliance. By leveraging generative AI, the platform ensures rapid access to critical information through natural language searches of SOPs while also enhancing data quality with detailed, AI-generated records. These capabilities allow Samsung Biologics to uphold stringent regulatory standards, improve operational efficiency, and minimize errors or delays that could disrupt productivity.
A cornerstone of this innovation is the platform’s Quality Document and Record Templates. Equipped with advanced natural language processing (NLP) capabilities, these templates enable users to facilitate the summarizing and indexing of quality records, ensuring that critical details are readily available to meet specific regulatory requirements. Document standardization serves as the groundwork for data digitalization. Furthermore, it simplifies document creation and maintenance, reducing compliance risks and enhancing the likelihood of on-time product delivery.
Central to the platform’s success is its RAG capabilities, a cutting-edge technology that combines large language models with external knowledge sources. In quality assurance applications, RAG retrieves the most relevant documents for a query, extracts essential details, and generates coherent, insightful responses. This approach transforms the inspection process, enabling Samsung Biologics' platform to deliver fast, accurate answers to even the most complex queries. By seamlessly integrating retrieval and generation, RAG ensures precision and clarity far beyond traditional methods.
To maintain consistency and accuracy during audits, the platform employs advanced strategies such as robust metadata management, intelligent query processing, version control for comprehensive audit trails, and evidence linking to connect responses with original source documents. Together, these features deliver reliable, error-free results, ensuring compliance and fostering trust with regulatory bodies.
While internal regulatory teams derive the greatest benefits, the platform significantly enhances communication with inspectors. Real-time access to critical information allows Samsung Biologics' staff to respond to regulatory requests within minutes, demonstrating efficiency and professionalism. Additionally, by enabling proactive preparation, the platform ensures that relevant documentation is well-organized before inspections, reducing the time and effort required during the audit process.
Ultimately, Samsung Biologics' AI platform not only improves inspection readiness but also fosters better collaboration with regulators. By equipping employees with powerful tools, it ensures swift, comprehensive responses that reinforce the company’s commitment to quality and compliance.
AI-Driven Efficiency in Biopharma Operations
Samsung Biologics’ AI platform extends its impact beyond audits and inspections, revolutionizing daily operations across the company. With advanced tools for document translation, summary, and drafting, the platform significantly optimizes resource utilization, enhances data analysis capabilities, and reduces the risk of quality issues and human errors.
The sheer volume of information generated daily — from multiple channels and formats — can overwhelm traditional processes. To address this challenge, Samsung Biologics' AI platform employs sophisticated algorithms to distill complex datasets into actionable insights. These capabilities empower decision-makers to stay informed about market trends, customer preferences, and operational nuances, enabling informed and timely decision-making.
The platform’s automation features have transformed routine tasks such as email composition, report writing, and note taking. By leveraging generative AI models, these time-consuming processes are streamlined, freeing employees to focus on strategic, high-value activities requiring human creativity and judgment. Furthermore, real-time data analysis and insight generation enhance resource allocation and workflow efficiency. The use of templates, particularly for email drafting and quality record management, has optimized these processes while improving the consistency and quality of outputs.
Global operations also benefit significantly from the platform’s advanced translation functionality. By using NLP techniques to address linguistic nuances, including dialects and idioms, the platform ensures seamless communication across diverse regions and cultures. Machine learning models trained on vast datasets of human translations, continuous feedback loops for accuracy, and integration with resources like dictionaries and encyclopedias are strategies that ensure high-quality, contextually accurate translations. This adaptability allows Samsung Biologics to maintain excellent service while meeting local expectations.
Another standout feature is the news summary function, which uses an application programming interface (API) to automatically aggregate industry news. Covering key updates on drug approvals, clinical trials, mergers and acquisitions, and regulatory changes, this feature saves time while ensuring that stakeholders remain informed about developments critical to decision-making.
AI has become indispensable in streamlining Samsung Biologics' daily operations, enhancing internal and external collaboration. Whether through automating repetitive tasks, synthesizing complex data, or bridging linguistic and cultural gaps, the AI platform continues to drive efficiency, innovation, and success across Samsung Biologics.
Charting the Future of AI at Samsung Biologics and Beyond
The success of Samsung Biologics’ AI platform stems from several critical factors, including top-down commitment from leadership, active participation by all relevant teams, a focused approach to data structuring and standardization, and continuous data analysis. Collaboration with Samsung SDS has been instrumental in driving this innovation forward.
Despite the significant advances already achieved, Samsung Biologics is only at the early stages of its digitalization journey. Future plans include expanding the application of GenAI beyond quality and regulatory domains to encompass sales, marketing, human resources, and finance. This strategic expansion underscores Samsung Biologics' commitment to leveraging AI as a comprehensive tool for business optimization.
In quality assurance and compliance, Samsung Biologics envisions deeper integration of AI to enhance documentation, refine compliance processes, and optimize quality control. Predictive analytics is poised to play a pivotal role, identifying patterns in quality control data to optimize manufacturing processes and mitigate potential risks. Enhanced adaptability to emerging regulatory standards and further integration of AI into daily workflows enable Samsung Biologics to anticipate and address deviations proactively.
A key focus for future development is the expanded use of quality-related data. By leveraging advanced analytics, Samsung Biologics aims to gain deeper insights into manufacturing processes, identifying potential issues before they arise. Complementary technologies such as machine learning and NLP are being explored to further enhance internal communication and collaboration around quality. These efforts are driving innovation and operational excellence across the organization.
To remain ahead of evolving industry demands, Samsung Biologics' AI platform undergoes regular updates and enhancements. Designed to adapt to shifting regulatory standards and industry practices, the platform ensures data compliance and operational alignment with best practices. This ongoing evolution positions Samsung Biologics as a leader in AI-driven quality and operational innovation within the biopharmaceutical sector.
