Rubius to pay $8m for ex-Soliris plant with troubled past

By Flora Southey contact

- Last updated on GMT

(Image: Getty/Susan Viera)
(Image: Getty/Susan Viera)

Related tags: Fda, Monoclonal antibody

Rubius has announced plans to acquire Alexion’s manufacturing facility in Rhode Island, where the latter made immunosuppressant Soliris before exiting the site last year.

The biotech announced the $8m (€6.8m) purchase and sale agreement of the 135,000 square-foot Smithfield facility in a US Securities and Exchange Commission (SEC) filing​ earlier this week.

Rubius Therapeutics plans to invest $155m​ over a five-plus year period in the facility, creating 160 jobs. The site will house multiple manufacturing suites to produce large quantities of clinical, and if approved, commercial red cell therapeutic (RCT) assets. According to Rubius, RTCs are selective, potent and ready-to-use therapies.

The site will also make lentiviral vectors to encode the biotherapeutic proteins inside or on the surface of each RCT.

“The acquisition of the Rhode Island manufacturing facility is a critical step toward making the promise of red cell therapeutics a reality,” ​said Rubius CEO Pablo Cagnoni in a statement​.

“We believe that by owning our manufacturing capabilities and controlling our supply chain we will be prepared to scale up manufacturing of clinical and potentially commercial supply of our novel therapies,” ​he added.

The purchase is expected close in Q3 2018, with completion of the first phase of renovations predicted within two years.

Ex-Alexion, ex-Soliris

Alexion Pharmaceuticals announced plans​ to close the Smithfield facility and layoff 20% of its workforce in September last year, as part of a cost-cutting plan aimed at saving $250m annually. 

The manufacturing facility made the active pharmaceutical ingredient (API) for human monoclonal antibody (mAb) drug Soliris (eculizumab), as well as the finished product, indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

Good manufacturing practice (GMP) concerns at the site have attracted US regulatory attention in recent years.

In 2013, the US Food and Drug Administration (FDA) issued Alexion a warning letter​ following an inspection of the site, which was followed-up by a re-inspection in 2014 and a Form 483​.

In August 2016​, Alexion revealed it had received another Form 483 for the Smithfield site, with observations relating to the “completion and closure of certain investigations, validation of surface sampling methods and monitoring of water systems.”

Rubius did not respond to a request for comment ahead of publication.

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