Swiss site set to make Biogen Alzheimer’s MAb from 2021

Biogen says construction of its manufacturing site in Switzerland is complete and will produce commercial supply of aducanumab if the potential Alzheimer’s blockbuster is approved.

Biogen has had a turbulent time with its proposed Alzheimer’s disease monoclonal antibody aducanumab. In 2015, data was announced that led the company to outline a Phase III study. Then in March 2019, late-stage results prompted Biogen to shelve the drug. Months later, the firm resurrected the program, after “new analysis of a larger dataset” showed the drug reduced clinical decline in patients with early Alzheimer’s disease.

While the saga continues – Biogen has now pushed back the date it expects to complete its filing with the US Food and Drug Administration (FDA) – the firm is busy prepping its manufacturing network to cope with what it envisages to be large-scale demand.

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“From a manufacturing standpoint, we currently expect to have adequate supply to meet anticipated demand for aducanumab initially using our facility in RTP [Research Triangle Park], North Carolina,” CEO Michel Vounatsos said during a Q1 conference call last week.

This will then be complemented by capacity at a new facility in Solothurn, Switzerland, he added.

Biogen began construction of the CHF 1 billion ($1 billion) monoclonal antibody production facility in Luterbach, Solothurn, Switzerland in 2015. At the time, the firm said it would offer 144,000 L of stainless-steel capacity, comprising of eight 18,000 L bioreactors with an output of 10 metric tons.

“The construction [of the facility] is complete, and its validation remains on track. We expect it to be operating by the end of this year and to be producing some of the commercial supply of aducanumab in mid-2021,” Vounatsos told investors.

“Overall, together with our collaboration partner, Eisai, we remain optimistic about the prospect of bringing aducanumab to market as the first therapy to reduce clinical decline in Alzheimer’s disease,” he continued.

“We hope that aducanumab marks the beginning of an era of new potential treatments for Alzheimer’s disease, and we aim to build a broad franchise across multiple targets and modalities. This includes BAN2401 which we are collaborating on with Eisai, multiple programs targeting tau, our collaboration with CAMP4 to identify new druggable targets, our acquisition of CK1 from Pfizer as a potential symptomatic therapy and our new collaboration with Sangamo to develop a gene regulation therapies for a range of neurological indication including Alzheimer’s disease.”