Revolutionizing viral vector and gene therapy manufacturing with fit-to-flex design

National Resilience, Inc. (Resilience), a technology-focused biomanufacturing company, is dedicated to broadening access to complex medicines.

Resilience teamed up with CRB to pioneer a groundbreaking initiative in biopharmaceutical manufacturing. Resilience aimed to design and build its first facility, equipped to meet the demands of the dynamic life sciences industry in Marlborough, MA – one of the fastest-growing life sciences hubs. The strategic site selection helped set the stage for a transformative project.

Designing for versatility

The challenge at hand was to design and construct a state-of-the-art facility that not only met the rigorous standards of viral-based vaccine and gene therapy manufacturing but also embodied the flexibility to cater to partners of varying requirements and sizes. The need for seamless transitions from clinical to commercial projects, along with multi-product support, required an innovative approach to facility design.

Our team utilized an integrated project delivery (IPD) approach to transform a 93,000-square-foot space in Marlborough, including a 25,000-square-foot central utility plant (CUP)/office expansion. The fit-to-flex design included six flexible work cells, small-scale fill/finish, labs, office space, a Just-in-Time (JIT) warehouse, central utilities, and a data center. The facility was strategically designed to support multi-product manufacturing, in-house testing options, and large-scale volume capabilities. Robust tech transfer platforms were implemented to ensure right-first-time deliverables.

The transformative power of purpose-driven design

The fit-to-flex design successfully realized Resilience’s vision to streamline the supply chain, from cell bank to drug product fill, enhancing transparency and productivity. The facility’s end-to-end capabilities not only facilitated continuous transitions between clinical and commercial projects but also helped position Resilience as a key player in the rapidly evolving field of biopharmaceutical manufacturing.

In alignment with Resilience’s mission to revolutionize novel medicine production, the collaborative effort created an innovative, efficient, and versatile CDMO facility. The design not only met the technical demands of vaccine and gene therapy manufacturing but also served as a remarkable representation of Resilience’s culture, capabilities, and commitment to innovation.