Bluebird chooses partner for manufacture of its first approved product

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Master1305)
(Image: Getty/Master1305)

Related tags: bluebird bio, apceth Biopharma, Zyntelgo, Gene therapy

Apceth announces that it will be responsible for the commercial manufacture of Zyntelgo, after its approval last week.

The European Commission’s conditional approval for Zyntelgo (autologous CD34+ cells encoding βA-T87Q-globin gene) saw bluebird bio receive its first approval​.

Shortly after, apceth Biopharma noted that it would continue its partnership with bluebird to be the commercial manufacturer of the product in Europe.

Christine Guenther, CEO of apceth Biopharma, said, “Being one of the very few companies worldwide to manufacture a cell-based gene therapy for commercial use marks a milestone for our company.”

The partnership between the two companies has been ongoing since 2016 and also sees apceth manufacture drug product for bluebird’s Lenti-D, an investigational treatment for cerebral adrenoleukodystrophy.

With several products nearing approval decisions​, bluebird is stepping up its own manufacturing capabilities.

Previously, bluebird added a 125,000-square-foot manufacturing facility​ to its network in North Carolina, US, in 2017. While earlier this year, the company opened its first manufacturing facility​ for the production of lentiviral vectors.

At the time of the latter deal, bluebird emphasised that the purchase was a means to ‘complement’ its existing, external manufacturing partners.

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