Umoja Biopharma, Inc.Read More
Biomanufacturing facility delivered 35% faster with lean execution
Designed and built to secure a promising new vaccine currently in Phase III trials, the 46,000-square-foot biomanufacturing facility project was executed using CRB’s lean ONEsolution™ delivery method.
The client knew they needed a state-of-the-art facility to deliver the precise science of fermentation, purification and solution preparation needed for a vaccine. They also needed precise logistics for warehousing and shipping a fragile biopharmaceutical product around the world.
CRB provided a full-service solution to meet their needs, including the right blend of stainless versus single-use process equipment to meet both capital and cost-of-goods goals.
Lean execution methods
ONEsolution builds off the lean approaches developed by our industry’s most respected professional organizations, such as the Lean Construction Institute (LCI).
Early trade partner engagement
CRB signed on all key trade partners within four weeks of the project’s kick-off. Early trade partner engagement is a key element of ONEsolution, but the practice is not typical in the life sciences industry.
With a full team assembled from the beginning, continuous constructability reviews of every design element were possible.
The Big Room
According to LCI, a Big Room is a space where all stakeholders come together and work, typically with visual documentation posted. Shared space supports communication and dialogue, resulting in work efficiencies.
The client, CRB and trade partners worked from a shared 6,000-square-foot Big Room from day one of the project. The Big Room helped to uncork the horizontal flow of information between teams and the vertical flow between senior leaders and on-the-ground project managers. Many times, this allowed us to bypass the traditional Request for Information (RFI) process. The team made decisions in actual time and co-developed solutions in days instead of weeks.
A conventional project of this size has about 1,300 RFIs, and each takes two weeks to process. This project had 51 RFIs, and we processed each in a matter of days. The average cost of an RFI is about $1,000, meaning a conventional project would have $1,300,000 in RFI costs while this one only had $51,000. Not only did the Big Room culture help us speed up decision-making on the project, it saved up to $1,249,000.
Focused work clusters
With the team in place and the Big Room established, we created four focused work clusters: the process equipment cluster, the cleanroom cluster, the utility cluster, and the office and logistics cluster.
LCI defines work clusters as a method for organizing the project team into smaller cross-functional groups to distribute the design tasks and responsibilities using targeted interdisciplinary teams. Work clusters break down the overall burden of high-value/high-risk project decisions with the help of cross-functional knowledge and distributed leadership among the group members.
Each cluster consisted of a system lead, who oversaw progress and coordinated with other clusters, and a bisection of design and construction team members whose skills covered lighting, mechanical, plumbing, process utilities, safety, maintenance, offsite fabrication, automation, commissioning and qualification.
The Last Planner System (LPS) is a lean system developed by LCI. Techniques such as pull (phase) planning, make-ready look ahead planning, and weekly work planning outline the entire construction process.
The principles of Last Planner aligned with the collaboration-heavy culture started by the Big Room and work clusters. Each pull plan required clarity about the sequence, scope and timing of promises made between operations. This required a mental shift: each discipline had to work inside a shared context, recognizing a hierarchy of mission-critical needs and determining next steps based on the highest of those needs (rather than basing daily tasks on insular objectives specific to individual operations).
Daily Big Room meetings enabled real-time updates on the promise of when and how each discipline released work. The team systematized those promises into weekly work plans.
Off-site modular construction
Industry standards show that a project of this scope would have 10% of its utilities and equipment fabricated off-site, but two significant challenges drove a much more aggressive modularized build strategy on this project: timeline pressure and skilled labor shortage.
Using building information modeling (BIM) technology to design continuously and release modular components, we had 60% of the facility equipment and utilities fabricated off-site.
A truly integrated lean strategy enabled by custom BIM toolsets helped to push that volume to 60%, which cut months from the project schedule and established a new template for our client’s future projects.
Fast-tracked design and construction schedule
The Construction Industry Institute (CII) schedule benchmark for projects of similar size and scope is thirty-seven months. We completed the project in twenty-four. Thirty-five percent faster than the industry standard.
Speed to market was one of our client’s biggest business drivers. The emphasis on true integrated project delivery, lean principles, and a culture of creativity and shared ownership resulted in a project that set a new standard for execution when it comes to saving lives.