In 2014, Amgen completed construction of its newest biomanufacturing facility, a 120,000 sq ft fully 2,000L scale single-use plant in Singapore, and is on track to begin commercial production this year.
At the BPI European Summit in Amsterdam last month, Art Hewig, director of Purification Process Development at Amgen, said the site incorporates all the areas of a conventional 750,000sq ft facility – manufacturing, mechanical support, QC Lab, warehousing, utilities and administrative space – but was built in half the time, at a quarter of the capital cost, and has a third of the operating expense.
With disposable technologies, modular lay-out and real-time remote monitoring, he told delegates the site is capable of reducing the cost per gram of protein by as much as 60% from a conventional facility and demonstrates that “flexible drug substance manufacturing is now a viable option for commercial operations.”
But this is just the first step towards creating a “flexible biomanufacturing network optimised for speed and cost that seamlessly delivers to the multi-modal product portfolio,” he continued, adding Amgen is already looking at the next-generation in bioproduction.
Long-term paradigm shift and holistic operations
He suggested the long-term future of biomanufacturing could lie in “backpack technology, or in the field manufacturing,” a concept currently being investigated by the military for making biologics in war-like environments.
Continued intensification of upstream bioprocesses will be necessary to move towards this paradigm, he said, but fully incorporating downstream technologies remains the largest hurdle.
“You may be able to shrink some of your equipment down and utilise high yield utilisation rates, but your buffer prep and media stays in this enormous conventional sized buffer prep and media.”
However, once this is overcome: “You can start to think about [facility construction time of] three to six months and manufacturing spaces in the order of 1,000 to 5,000 sq ft,” he said. “These really are possible right now and that really is where the next generation of manufacturing is coming.”
Industry must also move towards integrating drug substance manufacturing with drug product, Hewig said.
“It has been coming over time but maybe slower than I would like, but that’s the integration of your drug substance, drug product, your attribute sciences, and bringing a holistic and integrated view to that. How do you really think about these things as a singular operation?”