Biomanufacturing is advancing rapidly, and as the industry evolves, so too must the facilities that support it. Therapeutic modalities are becoming more diverse, and with the increasing demand for speed, flexibility, and sustainability in production, biopharmaceutical facilities must be prepared to meet these new challenges. At this year's 2025 ISPE Biotechnology Conference, the Biomanufacturing Facility Lifecycle track brings together a distinguished group of experts from across the industry who are at the forefront of this evolution to explore the transformation of biomanufacturing facilities and how to design, build, and operate them to meet both current needs and future demands.
Together, speakers and attendees will explore how biomanufacturing facilities are moving from rigid, static infrastructures to dynamic, adaptive ecosystems that can thrive in a rapidly changing landscape. What connects all these sessions is a shared focus on building facilities that are not only capable of meeting today’s demands but also flexible enough to embrace the needs of tomorrow. Each speaker will offer a unique perspective on how to make this a reality.
One of the most exciting topics covered is the shift from traditional, static capacity planning to more dynamic, real-time approaches that allow for continuous optimization. This is especially crucial as biomanufacturers face the complexities of managing multiple products, varying production schedules, and unforeseen disruptions. Minhazuddin Mohammed from Takeda will dive into the role of capacity modeling as a tool for future-proofing facilities. His session will highlight how Takeda uses real-time data and predictive tools not only for new builds and expansions but also for ongoing optimization. This approach allows facility teams to stay ahead of potential bottlenecks, improve resource utilization, and ensure that operations can scale seamlessly — even when dealing with unexpected disruptions such as supply chain variability or process and equipment failures.
The conversation will evolve into the critical role of facility design in meeting these biomanufacturing demands. Facility design is no longer just about creating functional spaces; it’s about designing adaptable, future-ready environments that can evolve alongside scientific and technological advancements. This year, Jacob Greenwood from Project Farma and Sue Marrichi from Ultragenyx Pharmaceutical Inc lead a panel discussion on how facility design and development are being influenced by innovations such as modular construction, digital integration, and flexibility. With regulatory challenges, workforce shortages, cost pressures and global sustainability goals on the rise, this session will provide valuable insights into how facilities can be designed to be both adaptable and efficient, allowing them to support an ever-widening array of therapeutic modalities and manufacturing processes.
In the face of increasing pressure to reduce environmental impact, sustainability has become an essential focus of biomanufacturing. One area where manufacturers can make a significant impact is in the design of HVAC systems, which are key to maintaining cleanroom environments while minimizing energy consumption. In a session presented by Angelo Bernardis and Barbara Bagatta from Wood Plc, attendees will explore how international standards like ISO 14644-16 are being applied to reduce energy usage in cleanrooms. Their work demonstrates how technologies like computational fluid dynamics (CFD) and adaptive control systems can help manufacturers reduce energy demands without sacrificing the quality and integrity of the production environment. This session will emphasize the importance of collaboration among engineers, operators, and compliance teams to achieve sustainability goals, while still maintaining high standards for cleanliness and operational efficiency.
Building off sustainability in facility design, this track will pivot to process architecture, a key element of any facility’s adaptability. Daryl Kern from PM Group, Grace Linton from CRB, Nevine William from IPS, Felix Diaz from Barry-Wehmiller Design Group, and Geoffrey Middleton from CGMA, Incorporated will guide attendees through a conversation about how thoughtful architectural choices can influence not only the efficiency and flow of production but also the speed of regulatory approvals and facility scalability. This panel will discuss how the integration of process and facility design is critical for ensuring that biomanufacturing environments can quickly adapt to changing product needs and regulatory requirements.
As the track draws to a close, Christian Lavarreda from Syntegon will delve into the increasingly important role modular hardware and automation design framework play in bringing sophisticated production capacity online in ever-shorter times. Through the implementation of digitalization and sophisticated control strategies with Artificial Intelligence (AI) and Machine Learning (ML) technologies, attendees will leave with a general understanding of such framework as well as an example blueprint for implementation in bioprocessing.
By the end of the track, attendees will have a deeper understanding of the innovative approaches to facility lifecycle management that are shaping the future of biomanufacturing. Pharmaceutical professionals, from engineers and architects to operations leaders, manufacturing specialists, and regulatory professionals will gain practical insights that can be immediately applied to their work. This track will cover the importance of dynamic capacity modeling, the role of innovative facility design, strategies for improving sustainability, how process architecture can streamline the path to flexible, scalable production and the important role of modular hardware and sophisticated control strategies.
This track is more than just a technical discussion; it’s an opportunity to engage with industry leaders, share experiences, and learn how all can contribute to building biomanufacturing facilities that are not only efficient and cost-effective but also resilient, sustainable, and ready to meet the challenges of tomorrow. Attendees are encouraged to attend, engage with the experts, and present questions. Together, we’ll shape the future of biomanufacturing facilities — one innovation at a time.
Learn more and register for the 2025 ISPE Biotechnology Conference today
