HALIX, a Dutch contract development and manufacturing organization (CDMO) focused on clinical and commercial proteins and viral products, has marked the interim completion of a new cGMP facility that will specialize in developing and producing biopharmaceutical drug substances.
The new 6,700 m2 (72,118-square-foot) cGMP facility is located within Leiden Bio Science Park, which houses the largest number of bioscience start-ups in the Netherlands among its 103 dedicated medical life sciences companies and institutions, which include Leiden University and Leiden University Medical Center (LUMC).
Construction on the cGMP facility began in July 2018.
“After a construction time of just 12 months we are now able to start production of viral products and protein production will follow soon,” Alex Huybens, HALIX COO, said in a statement. “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.”
HALIX has said it plans to expand its scope of services for therapeutic proteins and viral vaccines. The company specializes in GMP manufacturing of biologics, by manufacturing drug substance on eucaryotic cells, and by performing aseptic fill and finish and lyophilization services.
Full-scale operational production at the new facility will begin in the fourth quarter, HALIX added.
The five-level production facility contains a manufacturing line for viral vaccines and viral vectors, and a separate protein manufacturing area with a capacity up to 1,000 L single-use bioreactors. Lab space will be 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 biopharmaceuticals products, according to HALIX.
“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,” added Roland Hecht, HALIX’s chief customer officer.
The cost of the facility has not been disclosed.
Based in Leiden, the Netherlands, HALIX was founded in 2012 and is a 100% owned subsidiary of HAL Allergy Group. Both companies are owned by Droege Group, a family-owned investment firm specializing in long-term, equity-financed direct investments in medium-sized companies or corporate subsidiaries as a majority shareholder.
HALIX says it offers its clients end-to-end drug development services from the start of commercial production after successful registration of products.