The update was provided to the city council of Sachse by Mark Krause, SVP of operations at Evolve Biologics. The facility is set to be the first that uses Evolve’s PlasmaCap EBA technology to produce plasma-derived therapies, as well as becoming the company’s first and only manufacturing site.
When previously announced in 2021, the company outlined that the facility would cover over 200,000-square-feet and have an initial capacity to produce one million liters of plasma annually. Evolve also outlined that it would increase this capacity to two million liters through a planned expansion.
The company will hire approximately 300 new employees to work in the facility, who will be brought onboard at the same time as the substantial completion of the space.
During his speech, Krause outlined that the facility will see $200m (€182.3m) invested into its creation. The facility will be constructed on a 12-acre site, with the location housing 65,000-square-feet of clean room and 25,000-square-feet of administrative office space.
In terms of the scheduling for the construction of the facility, Krause noted that substantial completion is set for the end of 2024. However, he added that there would be a ‘significant amount of work’ left to do to bring the site to operational status, which would involve commissioning the equipment, as well as validation of equipment and the manufacturing process.
At the time of the recording, the construction of the facility had reached the stage of readying the walls of the building.
Krause was also asked about potential further expansion of the building itself, and he confirmed that this would likely happen when capacity will be raised to two million liters.
Evolve plans to use the site to manufacture its intravenous immunoglobulin, albumin, and alpha-1 antitrypsin product candidates.
Its intravenous immunoglobulin product is currently going through Phase III clinical trials, with an estimated regulatory submission date of 2024. Immunoglobulin products are used in various conditions, including primary immunodeficiency, polyneuropathy, and B-cell chronic lymphocytic leukemia.
The company is also at the clinical development stage for albumin, which is a protein that can be used in acute nephrosis, acute liver failure, and burns. Evolve currently states that alpha-1 antitrypsin is a ‘future product candidate’, and is an enzyme inhibitor that can be used for emphysema patients.