cGMP biopharmaceutical manufacturing facility
HALIX inaugurated its new current good manufacturing practice (cGMP) biopharmaceutical manufacturing facility at the Leiden Bioscience Park, Netherlands, in November 2019.
The facility produces viral and protein products. Construction on the facility began with the ground-breaking ceremony that took place at the site in July 2018, with completion in August 2019.
HALIX intends to use the facility for the development and production of biopharmaceutical drug substances and client-specific technologies.
The Leiden Bio Science Park in the Netherlands was selected as the strategic location for the cGMP facility as it is the largest science cluster in the Netherlands. It is home to 150 companies, 14 health care organisations, 11 research institutes and 11 educational centres.
The location offers a skilled workforce and state-of-the-art research facilities. The facility is well-connected to other parts of the country, as the area is close to the A44 motorway.
The cGMP facility occupies 6,700m² of space at the Leiden Bioscience Park. The building has four floors with each floor offering an area of 1,290m².
Its ground floor accommodates workplace areas, assembly rooms and the warehouse, while the first floor houses viral products manufacturing areas and laboratories. Protein manufacturing facilities are located on the second floor, whereas the third and fourth floors feature an expansion area reserved for future manufacturing needs.
The GMP facility focusses on project segregation by employing innovative concepts such as uni-directional process flow, single-pass air, pest control at change-over, interlock and security systems.
It also supports future expansions and offers flexibility for cGMP manufacturing solutions for viral products, proteins, gene therapy and client-specific technologies.
A 1,400m² area is reserved for future expansion for the production of therapeutic proteins and viral vaccines on a large scale. The building also offers space for logistics.
The biopharmaceutical facility contains a state-of-the-art manufacturing line for viral vaccines and vectors with an initial bioreactor volume of 250l. It also features a dedicated area for single-use bioreactors with a maximum capacity of 1,000l.
The laboratory area at the production facility supports process development and transfer, as well as analytical development and quality control of biopharmaceuticals.
Prepared for an upgrade from BSL2 to BSL3, the cleanrooms with a unidirectional process flow ensure commercial production of biopharmaceuticals. The office space, laboratory and cleanroom area can accommodate up to 70 employees.
The contract for the design of the GMP production facility was awarded to EGM architecten & DuPrie in 2018, while Kuijpers was selected as the main contractor for the project.
Cleanroom Combination Group delivered cleanrooms for the facility.
Founded in 2012, HALIX is a leading contract development and manufacturing organisation (CDMO) for GMP manufacturing of biologics.
Headquartered in Leiden, the Netherlands, HALIX is a spin-off of HAL Allergy, who are both owned by Droege Group.
With the prevalence of the Chikungunya and Zika virus in Africa and South America, HALIX ventured into the production of vaccines for the prevention of infectious and viral diseases. The company also focuses on therapeutic vaccines for the prevention of cancer.
HALIX provides end-to-end services to new and existing B2B customers from the initial developmental commercial stage to successful registration of products. The company is licensed for clinical and commercial GMP contract manufacturing of biopharmaceuticals.
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