DCAT Week 2026: Solving the Complexity Crisis
According to Maja Pedersen from FUJIFILM Biotechnologies, modularity, AI-driven compliance, and harmonized global networks are necessary to resolve complexity challenges in downstream processing.
The drug development pipeline is becoming increasingly saturated with complex and challenging molecules that are pushing traditional manufacturing models to their limits, driving the need for companies to seek out novel and sophisticated strategies. In this exclusive interview, The Pharma Navigator chats with Maja Pedersen, COO of FUJIFILM Biotechnologies, about some of the tools bridging the gap between early-stage development and commercial success.
Addressing Increasing Complexity
TPN: Molecules entering the development pipeline are becoming ever more complex, leading to greater hurdles downstream for developers. What solutions are available that are helping industry to streamline processes?
Pedersen: We’re seeing a clear shift toward increasingly complex biologics, which introduces significant challenges, particularly in downstream processing, tech transfer, and regulatory alignment. To address this, the industry is moving toward a combination of platform technologies, digitalization, and globally harmonized operating models.
One key area is innovation in purification and process development. Precision technologies like ShunzymeX are helping simplify downstream processing for complex molecules, reducing both time and variability. This technology can help developers to move more efficiently from early-stage development into scalable manufacturing.
Digital tools are also playing an important role. AI-enabled solutions, such as internal compliance and quality tools, can streamline documentation, accelerate deviation investigations, and improve consistency across global operations. As an added benefit to our employees, AI tools can help reduce the administrative burden, to allow team members to focus on strategic projects.
Equally important is the adoption of standardized, modular manufacturing approaches. By harmonizing systems, equipment, and regulatory frameworks across sites, companies can enable faster tech transfer and reduce duplication of effort. At its core, the integration of advanced technologies, digital tools, and globally standardized processes enables the industry to keep pace with increasingly complex molecules.
Flexibility without Compromise
TPN: The market is currently being reshaped by GLP-1s and ADCs. How can service providers ensure large-scale mammalian capacity remains flexible enough to pivot toward these increasingly complex, high-potency treatments?
Pedersen: Flexibility is becoming a defining requirement for modern biomanufacturing. With modalities like GLP-1s and ADCs driving demand, service providers need to design capacity that can adapt quickly without compromising quality or scale.
One critical component is the use of modular and multi-site manufacturing strategies. FUJIFILM Biotechnologies’ kojoX approach, for example, harmonizes equipment, processes, and quality systems across regions, allowing production to shift efficiently between sites while maintaining consistent quality standards.
Another important factor is investing in a balanced network that includes small-, mid-, and large-scale capabilities. Single-use technologies, in particular, provide flexibility at smaller scales, while large-scale facilities ensure the capacity needed for commercial supply. Having this range within an integrated network allows manufacturers to support a wide range of molecules and lifecycle stages.
Building multi-modality capabilities is essential. When combined with strong global quality and regulatory frameworks, this creates a resilient system that can scale efficiently while maintaining the highest standards of safety and compliance.
A Valuable Opportunity to Connect
TPN: Finally, what are you most looking forward to at DCAT Week 2026?
Pedersen: DCAT Week is a valuable opportunity to connect with partners across the global biopharma ecosystem, and this year is especially exciting given the pace of innovation and investment across the industry.
I’m looking forward to discussing how we, as an industry, can continue to build more resilient and flexible supply chains while accelerating timelines for increasingly complex therapies. It is also a great forum to share updates on the progress we are making across our global network, especially as we bring new capacity online and advance technologies that support our partners from development through commercial supply.
DCAT also provides the opportunity for me to engage in open dialogues with customers and my peers. Those conversations are critical to ensuring we are aligned on the challenges ahead and working collaboratively to deliver therapies to patients faster and more reliably.
About the Interviewee
Maja Pedersen is the Chief Operating Officer of FUJIFILM Biotechnologies, where she is responsible for site operations, supply chain, quality, process development and global manufacturing science and technology for the company’s global network. In her role, she leads teams overseeing about 4,000 employees across multiple regions and manufacturing sites.
Maja has spent more than 20 years in the biopharma industry, primarily in quality, regulatory, and manufacturing leadership roles. Prior to rejoining FUJIFILM Biotechnologies, she served as Global Head of External Manufacturing at Biogen, where she oversaw a global CDMO network. Throughout her career, Maja has focused on scaling complex biologics manufacturing, establishing strong quality systems, and enabling successful commercialization of life-changing therapies.