NEW YORK - Biogen Idec had issues with its Tysabri production: formulation, aging infrastructure and downstream processing bottlenecks conspired to make it difficult to keep up with demand for the multiple sclerosis drug.
The company reformulated the treatment in a higher-titer process, super-boosting output to 3 g/milliliter from the initial volume of 0.6 g/liter, says Mark Butler (pictured, left), principal at engineering and construction company IPS. But the new formulation required an overhaul of the multi-product bulk biologics facility's production infrastructure. Company calculations showed a lopsided build vs. renovate tradeoff: $350 million vs. $40 million.
Despite its attraction, the renovation option necessitated a Tysabri production shutdown, especially problematic given existing production yields and growing demand.
The solution involved a production setup including five vessels for cell culture support, says Gerald Cerulli (pictured, right), IPS process engineering director. And it earned Biogen Idec the 2010 Facility of the Year award for operational excellence, recognized this week along with other category winners at Interphex. The annual contest is run by ISPE, Interphex, and Pharmaceutical Processing magazine.
In a large-scale manufacturing technology map program at the company's Research Triangle Park, NC, site, engineers and process developers analyzed facility assets, evaluated new technologies, and prepared for new processes, all the while incorporating sustainability principles and balancing current ops needs with anticipated strategic needs for production of additional products.
The upgraded facility provides a 300 percent increase in yield over previous output. The higher throughput comes, in part, from facility and equipment improvements that provide faster and more streamlined technology transfers and process changeovers within the multi-product facility.
Project engineers timed the upstream and downstream renovations to capitalize on existing process flow, creating a rolling plant shutdown that minimized downtime. The team used modular construction, says Butler, allowing some building to be done offsite and then brought in and installed during a shutdown phase.