Biogen is in the midst of developing a drug that it believes could reshape how we treat Alzheimer's.
And in the process, it is hoping to reshape how biological-based therapeutics come to market. By using advanced analytics more actively during the fermentation process, Biogen believes it can produce its Alzheimer's drug for one-fifth of the cost of conventional biological solutions by streamlining the supply chain, reducing production losses and other techniques, said Biogen's Tim Alosi at the recent OSIsoft EMEA Users Conference in London.
Yes, it's a tall order, but read on.
Alzheimer's is, of course, one of the world's leading health problems. Twenty five million people worldwide suffer from the disease with the number reaching 81 million by 2050. In the U.S. it's the sixth leading cause of death.
“We need to drastically increase the output (of therapeutics) and dramatically reduce the testing time,” Alosi said.
Biological processes and fermentation are more challenging to produce than conventional medicines because, as natural processes, they can't fully be controlled. Variations and deviations become inevitable. Biogen asserts it can reduce the impact of variability by applying analytics early in the fermentation process to correct deviations. If the company can see a particular batch is going out of range, it can shift processes to bring it back in line. Currently, a company may not be aware of deviations until two days into the process.
The potential savings are immense. The industry average yield on biologics has hovered around 5 to 7 grams per liter. Biogen believes it can drive that to 15 grams. It also hopes to lower the timed tied up in logistics and shipping across the supply chain from 4 to 7 weeks to closer to a day through things like data sharing (i.e. being able to rely on a supplier's valid data instead of retesting) just in time manufacturing and handhelds that can confirm the chain of custody rapidly. The time required to get test results back, potentially, will drop by half.
Biogen is currently in the midst of installing two modular Bio-Manufacturing Cells for its “3X platform” in Switzerland. See below. (3X refers to the increase in yields from 5 grams to 15.). Biogen believes it will be able to serve up to 1 million patients by 2020. The site has the potential to install 7 BMC modules for a total capacity of 35 million metric tons per year.