Digital transformation is reshaping biomanufacturing, and FUJIFILM Diosynth Biotechnologies is at the forefront with its modular kojoX™ platform. By integrating advanced digitalization solutions and prioritizing data security, FUJIFILM Diosynth Biotechnologies is accelerating drug development while reducing costs and ensuring consistency across its global network. Through a focus on innovation, transparency, and security, FUJIFILM Diosynth Biotechnologies is aligning its operations with the future of the biopharmaceutical industry, setting new standards for efficiency, reliability, and regulatory compliance.
Harnessing the Power of Digitalization
Drug developers face dual pressures: reducing both the cost and time required to bring new medicines to market while managing the increasing complexity of drug modalities. Automation and digitalization have proven to be key components in addressing these challenges, as evidenced by their successful implementation in sectors like automotive and advanced manufacturing. The shift toward Pharma 4.0 — a concept heavily promoted by regulatory agencies like the U.S. Food and Drug Administration (FDA) — marks a pivotal movement in the industry. Most pharma companies are well into their digital transformation journeys, aiming to boost efficiency, productivity, and quality while driving down the costs tied to drug discovery, development, and manufacturing.
In this evolution, digital tools are helping companies streamline processes, reduce human error, and enable real-time data analytics across various stages of development and production. With automated systems, developers and manufacturers can make faster decisions, ensure consistency, and create more agile production models, ultimately supporting faster time-to-market without compromising safety or compliance. As the landscape evolves, those that fully integrate digital solutions will be better positioned to meet rising market demands and regulatory expectations.
Digitalization Amplifies New Data Security Challenges
In the biopharmaceutical production industry, digitalization encompasses several critical aspects: Laboratory Information Management Systems (LIMS), online sensors for process monitoring and control, centralized data collection and storage in the cloud, and big data analytics. These tools span the full spectrum from research and development through commercial manufacturing, supporting more efficient operations and faster decision-making.
However, with these advancements comes a heightened need for data security. As digitalization expands, so do the potential threats — ranging from lone hackers to organized crime syndicates and even state-sponsored cyberattacks. Each of these actors may have various motives but share a common goal: exploiting vulnerabilities in the healthcare sector. The challenge becomes even more complex in manufacturing, where some legacy systems cannot be updated as frequently as desired, leaving pharmaceutical companies exposed to potential breaches. Malware and ransomware attacks that compromise sensitive data or intellectual property and cripple key systems remain the biggest concerns, with the threat of data theft looming large over the industry.
Balancing Innovation and Security with Smart Risk Assessments
Effective data security hinges on thorough risk assessments conducted before implementing any digitalization solutions and requires ongoing vigilance throughout the digitalization journey. These assessments help identify potential vulnerabilities and ensure that necessary safeguards are in place to protect sensitive data and systems. A robust change control process is also essential, with every new digitalization project being reviewed by a data architecture board and a change advisory board. Additionally, staying aligned with the latest regulatory guidelines concerning emerging technologies is crucial for maintaining compliance and security.
Subject matter experts (SMEs) who are familiar with both the company’s existing processes and the planned digitalization initiatives should lead these evaluations. They must balance the need for innovation with the responsibility of minimizing risks. The key is to adopt an evolutionary approach — where human oversight acts as a check on machine performance and outcomes until sufficient data supports full automation. This ensures that digital solutions are applied strategically, minimizing the introduction of vulnerabilities while allowing for continuous innovation.
KojoX: Harmonizing Biomanufacturing for Speed and Flexibility
FUJIFILM Diosynth Biotechnologies has implemented a groundbreaking operating philosophy, which we call kojoX, to accelerate biopharmaceutical development while reducing associated costs. “Kojo” is a Japanese word with two meanings – ‘improvement’ and ‘factory’. The kojoX platform is a modular approach to bioproduction manufacturing designed to work across different sites, scales, modalities, and product life cycles, giving customers the flexibility, speed, and capabilities they need to meet market demand. By breaking down biomanufacturing into interchangeable modules, FUJIFILM Diosynth Biotechnologies can tailor solutions to meet specific customer requirements while maintaining both speed and flexibility. Through kojoX, the increased standardization of internal processes, equipment, and software enables quicker decision-making and enhances operational consistency and efficiency. Ultimately meaning that our partners can leverage the network to bring life changing medicines to the market faster.
KojoX eliminates operational variability and communication bottlenecks that can delay scale-ups or technology transfers. By harmonizing production through standardized development and manufacturing processes, we also minimize our environmental impact. With kojoX, our partners have access to a network of possibilities, from early development to scalable commercialization, enabling access to manufacturing capacity quickly, removing the need for their own investment in infrastructure expansions. The platform’s global network allows for seamless scaling (both up and down) and ensures rapid adaptation to changing market demands.
A key element of kojoX is the integration of digitalization solutions into every unit operation. This ensures transparency, consistency, and support for facility design, capacity expansion, tech transfers, and uniform manufacturing across locations. In addition, the platform streamlines product development and regulatory documentation, making it easier for customers to meet regulatory requirements while accelerating time to market.
Building a Secure Data Framework in the kojoX Ecosystem
Within the kojoX system, data security is achieved through the standardization of all IT platforms and security protocols across our global network. By utilizing uniform tooling, network layers, and setups, FUJIFILM Diosynth Biotechnologies simplifies the protection and maintenance of its systems and customer data. This standardization not only enhances security but also streamlines global operations, making it easier to monitor and safeguard critical information.
A core element of the kojoX philosophy is the use of equivalent equipment trains and processes at different facilities. This approach allows each suite to be digitalized and automated consistently, with data being centralized for a highly interconnected and secure network. Regardless of location, this system supports rapid technology transfers, while separate data layers ensure the appropriate segregation between enterprise and manufacturing information, minimizing risks.
Before any new digitalization or automation projects are introduced, comprehensive risk assessments are conducted. These assessments focus on the potential impact on Good Manufacturing Practice (GMP) compliance and evaluate risks related to external threats. Policies are established, and essential documentation is prepared to support these new technologies. FUJIFILM Diosynth Biotechnologies has created an escalation system and alert mechanism to ensure that any issues can be swiftly triaged for senior leadership and addressed. With access to top-tier IT and quality experts, we are well-equipped to bring the kojoX vision to life, ensuring both security and operational excellence.
Building the Future
FUJIFILM Diosynth Biotechnologies is on a mission to become the leading and most trusted CDMO in the world. Through our ‘Partners for Life’ vision, that is underpinned by three core pillars — people first, industry transformation, and unprecedented delivery FUJIFILM Diosynth Biotechnologies are redefining how global partnerships are built on trust and transparency.
While leveraging our kojoX framework to implement consistent digitalization and AI systems across our global network, our teams diligently monitor new advancements in data security technologies. Our ultimate aim is to ensure continued investments in leveraging all available technological applications that ensure cyber resilience for us and our partners. FUJIFILM Diosynth Biotechnologies recognizes that these are critical steps towards achieving our Partners for Life vision in terms of building trust, so that our partners accept and view us as an extension of their own organizations.