Every batch counts: Alzheimer’s treatment through digital transformation
While every adult in the developed world has at least heard of Alzheimer's disease, only those who have witnessed the degeneration firsthand likely know the breadth of Alzheimer's pernicious nature. Alzheimer's affects only 1.9 percent of Americans, yet is the sixth leading cause of death. Characterized by the loss of neurons and synapses in the brain resulting in gross neurological atrophy, Alzheimer's literally shrinks the suffering brain away. Post-diagnosis life expectancy ranges from a mere three-to-ten years, with the afflicted suffering from cognitive ability loss throughout. It's also the third most expensive disease to treat, consuming up to $77,500 per year, per patient.
Currently afflicting nearly 30 million people worldwide, Alzheimer's prevalence will continue to expand to an estimated 80 million sufferers by 2050. Most disheartening, there is no current treatment to stop or reverse the disease's progression.
However, some of the latest treatments are successfully slowing degeneration, giving hope to patients and families around the world.
Founded in 1978, the neuroscience medicine pioneer, Biogen, has developed a biologic treatment currently undergoing testing both in Europe and the United States. With Aducanumab, testing has shown that the drug slows cognitive impairment in people with early Alzheimer's diseases. Venturing on the success of those trials, and with hopes of treating more than one million Alzheimer's patients by 2020, Biogen broke ground on new production facilities as part of its Next Generation Manufacturing initiative.
With the goal of reducing per unit biologic drug production costs by 80 percent, scaling production and exceeding regulated quality standards, Biogen aimed to digitally transform its entire manufacturing process. Relying on a PI System data infrastructure and its PI Connectors linking both global and on-site applications, the Biogen team built a fully integrated control system that allows for immediate exceptions-based process review along with machine learning optimization.
Relying on robust and holistic data and visibility, process testing happens in real time. Now, Biogen can make immediate adjustments rather than waiting hours or days for test results to reveal that an entire batch has been spoiled. By connecting test data from raw material suppliers with advanced on-site scanning technologies, all while automating and streamlining the materials acceptance procedures, raw material lead time has been reduced from 4-7 weeks down to one day.
With true, just-in-time inventory, the assurance of quality raw materials and the ability to bring testing to the production floor, Biogen is giving hope to Alzheimer's patients around the world.