Commissioning and Qualification (C&Q) for Facilities, Utilities & Process Equipment
Biogen Inc. is a biopharmaceutical company that focuses on discovering, developing, manufacturing and delivering therapies to people living with serious neurological, rare and autoimmune diseases. The Durham facility is a 250,000-square-foot LSM plant with the capability to run up to 120,000 liters of bioreactor capacity.
Sequence was awarded the scope for renovation of an existing manufacturing facility which included: Upstream/ Downstream Processing Suites, Buffer Prep, and new process equipment. Sequence developed the commissioning master plan for the Facilities, Utilities, and Process Equipment and performed commissioning services for twelve (12) seed train bioreactors and four (4) separate purifications systems, including development and execution of all commissioning documentation for all in scope process equipment. The Sequence team included 13 team members. Sequence Project leads were responsible for planning all activities for these resources, including scheduling across two shifts. This effort resulted in successful turnover to site validation and production without delays to production schedule.
Biogen is making advancements in pharmaceutical manufacturing and medical research programs. Its active research includes treatments for conditions like multiple sclerosis, spinal muscular atrophy and other serious neurological conditions.