Biogen on aducanumab: ‘We’re ready for an immediate launch’
There are around 900 sites across the US ready to implement treatment, including clinical trial centers and others with the necessary infrastructure to diagnose and treat patients.
Initial supply will come from Biogen’s Research Triangle Park (RTP) in North Carolina: but Biogen eyes up global potential for the drug with its Solothurn, Switzerland facility leading supply.
The monoclonal antibody, branded as Aduhelm, was granted accelerated approval for the treatment of Alzheimer's by the FDA earlier this week: making it the first drug for the diseases approved since 2003. It is the first therapy to target the underlying diseases process of Alzheimers, unlike other available therapies which only treat symptoms.
North Carolina facility ready to supply US patients
Nicole Murphy, senior vice president of global manufacturing and technical operations, says its manufacturing chain is ready to supply the drug to patients in the US and – if approved – globally.
“We have currently completed all operational readiness activities to enable launch, utilizing our extensive global manufacturing and supply capabilities across our integrated network,” she said on a company call on Tuesday. “Throughout the pandemic, we have leveraged our strategic supplier relationships to proactively build increased critical raw material and component inventories, to risk mitigate anticipated potential shortages related to Covid.”
“Following our announcement that we would file aducanumab with the FDA, we immediately responded by adjusting our internal asset production configuration, and rapidly increased our capacity through various construction and plant upgrades across drug substance and drug product at our manufacturing campus in RTP North Carolina.”
Manufacturing has since been taking place in the US from Biogen’s own sites and third party CMOs.
“I am very happy to share we expect to begin shipping product in about two weeks’ time," said Murphy.
Further afield, Biogen says it is ready to take the drug global.
"Through our strong end to end supply chain we believe we will also believe we will be ready to supply aducanumab beyond the US in various potential global markets if approved,” continued Murphy.
While the North Carolina facility is currently the focus of aducanumab supply, Biogen’s Solothurn, Switzerland facility will eventually be the lynchpin of global manufacturing.
“If approved, Solothurn would be our primary source of drug substance, with RTP [North Carolina] acting as a critical dual source and backup as we seek to ensure a resilient supply to patients,” noted Murphy.
Biogen started building the Swiss facility – ‘one of the largest, state-of-the-art biological facility builds’ - in 2015, putting an investment of around $2bn into the multi-product facility for multi-product facility.
The facility will host two biological manufacturing cells for aducanumab: one is already operational and the other will become operational in the coming months.
This will equate to 148kL of production capacity in Switzerland.