One can be relatively certain that for any organization initiating and executing a project as capital intensive as building a biopharmaceutical processing facility, the strategic case for its potential return on investment must be clearly articulated as well as sustainable over the long haul. For contract manufacturing organizations serving Biopharma’s growing global production capacity needs, fielding innovative, technologically advanced manufacturing assets in high-potential markets is elemental to business success.
Clearly articulating its long-term strategic and global interest in biologics, last October DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM, officially announced opening of its new cGMP facility for biopharmaceutical contract manufacturing in Brisbane, Australia. Australia’s Therapeutic Goods Act (TGA) regulatory agency granted the plant its A2 compliance rating, thus green lighting commercial operation. The facility was built in partnership Biopharmaceuticals Australia and some (AU) $60 million in financial backing from regional and national government agencies.
Since its opening in October, DSM has been conducting process development work and technical production runs and says that TGA-licensed cGMP production is scheduled to commence January 2014. Pharma industry analysts and financiers often find a robust supply chain of key assets analogous to a string of pearls. According to DSM, its bioprocessing pearl is contracted to serve several companies eager to be in a position to compete in Asia-Pacific market. According to DSM, “This world-class operation in the Asia-Pacific region is an important growth area in DSM’s strategic development in the biopharmaceutical field.” As it stands, the Brisbane facility is hosting manufacturing operations for DecImmune Therapeutics (US), RECEPTA Biopharma (Brazil) and two Australian firms, Parenta Biosciences and Opthea Pty Ltd.
A MODEL FOR THE FUTURE
“With its flexible design and use of single-use technology, the facility represents the model for the future of biomanufacturing,” said Lukas Utiger, president and CEO of DSM’s Pharmaceutical Products business segment at the time of the plant’s opening. “It represents an important milestone in the development of Australia-based mammalian cell-based manufacturing of biopharmaceuticals, and extends DSM’s contribution to the global biotechnology market.” The new facility, says DSM, was designed by an expert international team of biological scientists and bioengineers, “utilizing DSM’s 27 years of experience in mammalian cell culture processing to construct a purpose-built, state-of-the-art biomanufacturing facility.”
DSM’s new plant, at 86,000 square feet, may not be the world’s largest biopharmaceutical operation, but its flexible design philosophy assures that the space provides ground-breaking levels of efficiency and capacity for each square foot. DSM says the single-use approach reduces overall operational and process costs, enables rapid product change-over and reduced batch cycle times. Product capacity is projected at 500 kg annually, with bioreactor capacity ranging from 50 to 2,000 liters.
In a recent conversation with Frank Maddalo, VP of Operations/Facility Development for DSM Biologics, he revealed that the plant’s design wasn’t the only thing that required flexibility. Maddalo directed the project internally and was responsible for managing the teams designing, engineering, constructing and eventually the commissioning and qualifying of the facility.
Maddalo, outlining the project’s timeline, explains that while the deal was finalized in 2009, the project broke ground in June 2010. Construction started as scheduled, but in 2011, Mother Nature had other plans for DSM and its contractors. “In the midst of flooding in 2011, the construction site was completely inundated. It shut down the whole area for approximately a month, keeping the project shut down. We were completely over our time budget. Maddalo says quick thinking and the flexibility of the contractors on site found the solution to the loss of time was to tactically switch work from the Translational Research Institute (An element of the Australian Government’s Participation at the site) to DSM’s process building.” Maddalo notes that in spite of this major setback, neither the schedule nor the budget took a major hit and the project proceeded as planned.
ACCESSIBLE, EFFICIENT LAYOUT
Maddalo says the Brisbane plant incorporates a variety of design strategies to facilitate operations and assure pathogen and contamination defense without impinging on accessibility by employees and customers. “One of the other interesting things we’ve done is we’ve put in corridors that traverse the bioreactor suites. We actually raised the corridor above the clean rooms. It offers a great view — you’re getting a bird’s-eye-view from the top down able to look into as many as eight out of the 10 areas at one time.”