by Kevin Chronley
Project success is based on delivering predictable results; the pandemic and resultant supply chain crisis created numerous impacts to this matra. The dynamic uncertainties of labor and materials offer a stiff headwind to meeting the defined objectives for large, technically complex projects. Specifically, these challenges affected Nitto Avecia (NA), a cGMP manufacturer in Milford, Mass. With the evolution of RNA therapies, NA is a critical supplier of a new generation of oligonucleotide.
Increasing production was a strategic requirement for NA, despite this constrained marketplace. NA fostered a collaborative approach with A/Z Corporation to realize objectives to deliver a new Large Scale Process Development (LSPD) facility and a new cGMP manufacturing facility.
New innovative cGMP manufacturing facility
A/Z integrated our design partners, key subcontractors and, most notably, the client Nitto Avecia, to successfully build this 66,000sf, $23 million facility, which uniquely started during the very onset of the pandemic and wrapped up in 2021. The project objectives for budget and schedule were achieved, albeit subject to the uncertainties of the environment, the hybrid workplace adjustment, the supply chain crisis for materials and labor, and record inflationary pressures.
The success of this project was not an anomaly. Once the LSPD project was complete, we transitioned into constructing a new 91,200sf, 2-story, cGMP manufacturing facility and tank farm initiative. The $104 million project experienced even more challenging aspects; however, we used collaboration to achieve success.
The innovative scaled-up and added cGMP capacity expansion project will maintain NA’s market leadership position. Our collaborative effort included PM Group on the LSPD project, and Jacobswyer, DPS, Pare, and many key subcontractors, including Robert Mitchell, Process SME, Bratton Electrical, and Hart. These partners are integral to our ability to move toward defined objectives with predictable results.
Both projects were subject to most all of the challenges associated with the pandemic, yet collaboration and/or an integrated design-assist approach delivered predictable outcomes, albeit a multitude of dynamic contingency plans. The projects experienced impacts with structural steel sourcing, electrical gear delays, innovative process design, and a myriad of supply chain and sequencing workarounds. Our collaborative approach has served us well to keep us on track to deliver these technically complex and innovative cGMP facilities. Some examples of challenges the project faced and the creative collaborations utilized to overcome obstacles include:
- Developed a D/B approach to project execution. Leveraging continuity in project understanding and development through a streamlined, integrated team.
- Integrated key subcontractors into a design-assist approach. This was evident in structural steel fabrication, process mechanical, electrical, and controls contractors. Again, we leveraged a design-assist approach to integrate and streamline the scope.
- Funded long-lead procurement early. In select circumstances, we compressed the time frame from purchase to delivery by initiating the shop drawing/submittal process early to facilitate design collaboration and design-assist approaches without having a final IFC spec and funding.
- Developed a procurement strategy in precon, with contingency alternatives and early specs/packages for long-leads. Strategies include FAT verification and utilization of refurbished or custom-built on-demand supply resources.
- Provided early facility assessment, infrastructure capacity, and 3D scanning to integrate into design development.
- Engaged users in work sessions to better understand requirements. The project was expedited by having key constituents present, engaged and incorporated input for the planning, design and procurement.
- Initiated commissioning, testing, or CQV into planning schedule from day one.
Collaboration is an extraordinary attribute to achieve project success. The extreme challenges that have universally hampered projects in the Covid-19 pandemic and resultant inflationary impacts, and/or the supply chain crisis in materials and labor, can be greatly mitigated through collaboration. The dynamic challenges require agile and creative problem-solving. Timeliness is critical to the assessment and agreement to alternatives, contingencies, and work-around solutions. The integration of key constituents, most noteworthy Nitto Avecia, to collaborate, coordinate, and communicate execution plans that result in success, was paramount.
Kevin Chronley
Kevin Chronley is vice president of A/Z Corporation.
