Leiden, The Netherlands (26.03.2021) – HALIX B.V. is a contractor of AstraZeneca for large-scale commercial drug substance manufacture of AZD1222, AstraZeneca’s COVID-19 vaccine.
While discussions in the political arena are taking place, HALIX attaches importance to clarify its role with the following statements.
As is common practice within the biopharma industry, the production and supply chain for a medicinal product is divided for each part of the chain to several contracted companies. HALIX is one of AstraZeneca’s drug substance manufacturers. Drug substance needs to be filled and finished by specialized companies which are also contracted by AstraZeneca, so that AstraZeneca can supply the AZD1222 vaccine in doses, ready to be used.
The drug substance manufactured by HALIX is collected by AstraZeneca from HALIX’s facility in Leiden and transported under their command to one of AstraZeneca’s fill & finish partners. AstraZeneca is responsible for the final quality release of the AZD1222 vaccine and its distribution to the final destination.
AstraZeneca as the market authorization holder of the AZD1222 vaccine is responsible for filing applications within the EU to EMA before the vaccine can be used. In order to obtain EMA’s approval, AstraZeneca has submitted data generated during the manufacturing process of the AZD1222 vaccine. This manufacturing process is defined and prescribed by AstraZeneca for execution by HALIX, as one of the drug substance manufacturers for the vaccine. AstraZeneca expects to receive EMA’s approval end of March 2021.
Alex Huybens, Chief Operations Officer, states, “We are committed to continue our work for the manufacture of the drug substance of AZD1222 at our facility in Leiden and remain focused to support the vaccine production and combat COVID-19.”
HALIX B.V. is a biopharmaceutical contract development and manufacturing organization (CDMO) for biologics enabling the treatment and prevention of life threatening diseases. The company is focused on mammalian expression systems for the production of viral vectors and recombinant proteins. HALIX leverages scalable single-use, state-of-the-art bioprocessing technologies to provide its customers with services for the development and GMP manufacturing of drug substance and drug product. HALIX has entered into a number of contracts for the production of oncolytic immunotherapies and vaccines, utilizing innovative technologies. The company opened its state-of-the-art 6,700 m2 GMP manufacturing facility in 2019, offering 1,000L SUB capacities, at the Leiden Bio Science Park, the Netherlands. HALIX belongs to the family owned Droege Group AG. More information is available on: www.halix.nl
Corporate Communications HALIX B.V.