Month: January 2024

Umoja Biopharma, Inc., a clinical-stage biotechnology company, sees a different future for oncology and autoimmunity treatment—a future that provides improved patient access and alleviates the burdens of traditional treatment paths. Umoja’s VivoVecTM in vivo gene delivery technology empowers a patient’s own immune system to fight disease. Enabling its core technology is the Company’s state-of-the-art lentiviral vector development and manufacturing facility in Louisville, Colorado.

As Umoja’s pipeline development advanced, it outgrew its existing laboratory space, and the team identified a need for a larger, permanent facility to not only support its current early development efforts but that would be ready for full-scale commercial production at a future date. CRB provided end-to-end integrated project delivery for engineering, architecture, procurement, and construction for Umoja’s first stand-alone development, clinical manufacturing and lab facility, The CLIMB (Colorado Laboratory and Innovation Manufacturing Building). The new Louisville, Colorado, facility provides approximately 77,000 square feet of finished space, with another 69,000 square feet available within the structure’s core and shell for future expansion.

Purpose and objectives defined with a project charter

From the start of this ATMP project, CRB worked to understand the client’s goals and drivers. The team developed a comprehensive plan identifying the project’s business case, conditions of satisfaction and major milestones. Key objectives came to light during this phase that would largely shape the project’s direction, including the need for futureproofing, product flexibility, production scalability and deeply held social and environmental values.

Modular design

While still within the therapy’s development phase, Umoja needed a GMP-compliant facility that would allow for different methods and scales of production, multiple modalities, and quick growth and repurposing of space for scalable processes. To meet these needs, we designed the facility for easy additions and shifts to manufacturing suites. Each suite or module can expand into the next module, and a completely separate train of suites can be added using the same circulation and support spaces. The CLIMB’s modular suite layout allows for easy configuration and reconfiguration of space, with more traditional assemblies allowing for simple additions and modifications as needed. Each manufacturing suite has its own HVAC system to segregate the space and provide maximum flexibility and rapid turnover as product pipelines change, expand or grow. Additional future planning steps include a facility master plan to provide layout guidance while ensuring personnel, raw materials, waste, and product flows remain optimized, along with rated demising walls in select areas to minimize disruption and downtime during future construction.

Reflecting company culture and values

The clinical manufacturing ATMP facility draws from industry sustainability and wellness best practices to promote a green and inclusive workplace.

Sustainability

Strong energy and water conservation measures were leveraged, from lighting sensors to restroom fixtures, with the overall design supporting a 2031 zero carbon emissions goal. Our team conducted a sustainability master plan to understand how the new facility design could best prepare and support this phased goal, including allocating space in the central mechanical room for electric boilers and locating majority of the air handling units (AHUs) on the 2nd floor to reserve roof space for future solar photovoltaic (PV) panels.

Well-being

Designed to a WELL Silver equivalent, The CLIMB thoughtfully promotes good health and well-being of its occupants. Throughout the labs, offices, coffee bar, and multiple collaboration spaces, you’ll find unique lighting and energizing pops of color. The facility features large sweeping windows with ample natural light for daylighting and scenic views, all gender-inclusive restrooms and shower rooms, and a carefully planned lactation room for new parents to comfortably return to work. The inviting staircase off the front lobby creates interest and interaction encouraging the use of the stairs over the elevator. The material palette, including joyful colors and natural textures, integrates biophilia and beauty in the space by rooting the design in the local Rocky Mountains. Architectural programming integrated collaboration spaces at intersections throughout the entire facility to blur boundaries between distinct employee groups, build community and encourage creative thinking. Further promoting employee well-being, there are outdoor walking paths with fitness stations, covered picnic areas, bike racks, and views of the mountains with daily visits by grazing cattle in the adjacent pasture.

Umoja’s vision included a commitment to diversity, equity and inclusion even during the facility’s development and execution. As CRB owned this complete process, we performed regular check-in meetings with the entire team. We engaged the project teams, from on-site trade partners to the client’s PMs, with anonymous weekly surveys to track mental health, physical health and project satisfaction.

Staying true to company values, the Umoja team—along with their extended CRB team—quickly established themselves within the local community through regular volunteer outreach projects, from helping at the local foodbank to tending the land at a nearby trail and park.

Lean and integrated project delivery

Driven by the urgency of delivering critical patient care, speed to market maintained the utmost importance throughout the project’s development and execution. Leveraging an integrated project delivery method allowed us to move forward quickly, succinctly and with agility among 25+ companies, CRB and Umoja. The team used lean pull planning to outline construction activities and sequencing, along with a daily planning tool for complex coordination. These lean construction techniques were used to promote early schedule and cost certainty. While we engaged in early procurement and prefabrication to reduce supply chain risks and long lead times, some supply chain challenges still arose. By banding together as an integrated team, we were able to identify alternates, reengineer, and find solutions.

The safety and well-being of all team members extends into every facet of this ATMP facility, which included the highest standards for EHS. The project concluded with over 200,000 safety man hours without a Lost Time incident or OSHA recordable. This includes approximately 500+ unique crew members on-site over the course of the project, with a peak crew size of 150.

New life from a new ATMP facility

This core and shell spec space has been transformed into a fully functioning manufacturing, R&D laboratory, administrative and warehouse facility with a newly added second floor. Along the way, the MEP systems (mechanical, electrical, and plumbing) were rightsized to answer the high demands of clinical manufacturing and laboratory spaces, a floorplan was reimagined for the future, and engaging new designs infuse the space with vibrancy and character. Umoja is now one step closer on its journey to providing care to patients in need.