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AstraZeneca taps Halix for commercial drug substance manufacture of COVID-19 vaccine

Gareth Carpenter — 9 Dec 2020

Dutch CDMO will expand with two additional viral vector production lines to meet the increased demand

AstraZeneca has signed up Halix for large-scale commercial drug substance manufacture of its adenovirus vector-based COVID-19 vaccine, AZD1222, the Dutch contract development and manufacturing organisation said Tuesday.

Under the agreement, Halix will provide commercial manufacturing of drug substance at its cGMP facility at the Leiden Bio Science Park in the Netherlands.

No further details of the terms of the contract have been disclosed.

The CDMO said that to meet the increased demand, it will expand with two additional viral vector production lines.

The agreement sees Halix continue its role as one of the original partners in the University of Oxford’s consortium for the manufacture of AZD1222, which was co-invented by the University of Oxford and its spin-out company Vaccitech.

“Through the consortium, the partners are bringing their collective expertise and manufacturing capabilities to support vaccine production and combat this evolving crisis,” said Alex Huybens, Chief Operations Officer, Halix.

Well established in the development and GMP manufacture of viral vectors used in immuno-oncology and to vaccinate against infectious diseases, Halix’s 6,700 m2 Leiden facility provides both clinical and commercial scale manufacturing capabilities in Grade B and C cleanrooms for virus products.

Results of an interim analysis of Phase III tests on AZD1222 were published in medical journal The Lancet Tuesday, demonstrating that the vaccine is 70.4% effective at preventing symptomatic COVID-19 and protects against severe disease and hospitalisation. The interim analysis for efficacy was based on 11,636 participants accruing 131 symptomatic infections from the Phase III UK and Brazil trials conducted by Oxford University and previously announced on November 23.

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