Biogen Idec Large-Scale Manufacturing Biotech Facility - EPC

Client: Biogen Idec

Location: Research Triangle Park, NC, U.S.

Map showing the location of Biogen Idec Large-Scale Manufacturing Biotech Facility - EPC

Executive Summary

Fluor provided conceptual design, engineering, procurement, construction management and validation (EPCmV) services to Biogen Idec for the company's Large Scale Manufacturing (LSM) facility in Research Triangle Park, North Carolina.

Biogen Idec contracted with us to design, build and validate a 250,000-square-foot LSM plant with the capability to run up to 120,000 liters of bioreactor capacity. At the time, it was one of the largest cell culture manufacturing facilities in the world.

Biogen Idec began making product just 32 months after groundbreaking of the multi-product biologics manufacturing facility.

The Fluor team was cited for exceptional design, innovative modular construction methods and outstanding safety record. We delivered the project to the client under budget and one month ahead of schedule.

Client's Challenge

Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as multiple sclerosis (MS), lymphoma, neurological diseases and rheumatoid arthritis.

In July 1999, Biogen Idec contracted with us to design, build and validate a 250,000-square-foot LSM plant with the capability to run up to 120,000 liters of bioreactor capacity.

At the time, LSM was one of the largest cell culture manufacturing facilities in the world that could produce multiple products. The project expanded Biogen Idec's capacity to launch new products quickly and set new standards in the biotech industry for production cost efficiency and flexible multiproduct operations.

The LSM facility includes cell culture processing, purification, process support and clean utilities including clean in place (CIP).

Fluor's Solution

We were selected to execute the LSM project based on our demonstrated capabilities in the biotech industry and proven performance on prior Biogen projects. This project highlighted Fluor's expertise in the areas of process technology, modular construction and validation. Innovative advances for the LSM project included large-scale bioreactors, large-scale purification, buffer concentrates with online dilution and extensive use of “unclassified” space for processing.

The project logistics were extremely complex. We simultaneously coordinated the design and assembly of modules from three equipment supplier sites. Many of the construction workers did not speak English, so site signage and training materials were translated to ensure personnel understood what was expected of them in the areas of project execution and safety.

The true success of our team effort culminated in delivering the project to Biogen under budget and one month ahead of schedule.

The LSM project also demonstrated our focus on safety as a core company value. The LSM site celebrated 2 million hours without a lost workday case. This outstanding effort contributed to our achieving 5 million safe work hours in North Carolina, earning Fluor the North Carolina Department of Labor's highest safety award.

Conclusion

Biogen Idec selected Fluor for this important biotech project because of our successful performance on other projects dating back to the early 1990s. We understood Biogen Idec's critical need for an accelerated schedule to get new products to market and worked closely with all stakeholders to meet the client's requirements.

This fast track project was completed in 2001 and at the time was one of the world's largest cell culture facilities producing biologics vaccines.

The use of modular construction for the LSM facility was a first in the biotech industry. The modules had to meet the FDA's Current Good Manufacturing Practices (CGMP), and we implemented stringent methodologies for coordination and management during module design, fabrication and delivery.

In addition to delivering the project one month ahead of schedule and under budget, we also completed the project with an excellent safety record, as recognized by North Carolina's Department of Labor.