Project: Shire Human Genetic Therapies, B400 2×2 Manufacturing Expansion Project
Location: Lexington, Massachusetts
The project scope includes the expansion and phased renovation of Shire’s 190,000 SF biologics manufacturing facility over a 30-month period. The project will provide Shire with significantly more manufacturing capacity, as well as the ability to manufacture additional products in the plant. Noteworthy scope items include:
- The expansion of the existing manufacturing footprint with the conversion of office area into new manufacturing suites
- Construction of upstream and downstream suites within operational clean areas
- Installation of new process equipment throughout the facility in both new and existing suites
- Process utility generation and distribution improvements, including the installation of new systems as well as the expansion of existing systems
- Significant structural reinforcements, as well as various back of house support improvements
The Cardinal Group was engaged by Shire during the concept phase to provide planning, estimating, and preconstruction services. Our team worked closely with the client to refine the project scope and establish a cost model. The Cardinal team also developed an execution strategy to meet the numerous turnover milestones dictated by manufacturing’s schedule requirements.
Following preconstruction, the Cardinal team was selected by Shire to provide procurement and construction management services for the full 2×2 program.
All of the construction on the 2×2 program was performed within an operational FDA-licensed facility. Performing work in this environment requires a tremendous amount of planning, attention to detail, and close coordination with the client. From the beginning of concept design through all phases of construction, the Cardinal team led the planning effort with all stakeholder groups.
In order to support Shire’s demanding manufacturing schedule, the 2×2 program was broken up into twelve projects that were built, validated, and turned over independent to one another. This approach presented unique challenges for the Cardinal team to manage. Over the course of the project, work was performed in all areas of the plant, often times in multiple areas concurrently. Scheduling and logistics planning were of the utmost importance. During the most critical areas of work, activities were scheduled by the hour. Our team used their expertise to successfully complete all activities without impact to the client.
Another challenge presented by the phased requirement of the project was procurement. Similar to construction, the design was being performed in a phased approach to accelerate the completion of the project. The requirements of the project schedule dictated that subcontractors and vendors be brought on board to complete early work while the majority of the program was in concept. By coordinating closely with the design team and developing unique contracting strategies, the Cardinal team implemented a procurement strategy that provided Shire with a strong commercial position throughout all phases of the project.