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The new facility will manufacture biopharmaceutical products under cGMP conditions.
HALIX, a Netherlands-based contract development and manufacturing organization specializing in clinical and commercial proteins and viral products, announced on Aug. 9, 2019, that it has completed its new cGMP manufacturing facility in Leiden Bio Science Park, the Netherlands.
The 6700-m2 facility, completed after a year of construction, will be used for the development and production of biopharmaceutical drug substances. Operations at the facility are expected to start up in the fourth quarter of 2019.
The facility consists of five-levels and contains a state-of-the-art manufacturing line for viral vaccines and viral vectors in addition to a separate protein manufacturing area with a capacity of up to 1000-L single-use bioreactors. Lab space is also available for process development, analytical development, and quality control. All cleanroom areas have a unidirectional process flow and are designed to allow commercial manufacturing of biopharmaceuticalproducts.
“This new facility offers our current and future clients capacity and flexibility for future expansion and will allow for cGMP manufacturing solutions for viral products, proteins, gene therapy, and client-specific new technologies,” said Roland Hecht, HALIX chief customer officer, in a company press release.
“We are very pleased to have met this major milestone for our new manufacturing facility. We have made great progress under very aggressive timelines. After a construction time of just 12 months, we are now able to start production of viral products and protein production will follow soon. This milestone aligns with our growth and expansion strategy that will enable us to accommodate the growing market demand as well as our clients’ demands,” added Alex Huybens, HALIX chief operations officer, in the release.