uniQure B.V., a human gene therapy company, today announced it has commenced build-out of a state-of-the-art 55,000 square foot US manufacturing plant in Lexington, Massachusetts for the production of commercial grade Adeno Associated Virus (AAV)-based gene therapy products to complement its current EMA-approved site in Amsterdam, the Netherlands. The Company expects the facility to be operational by early 2015.
The US site will significantly expand the Company’s current production capacity. Once completed, it is expected to allow uniQure to capitalize on its modular manufacturing platform and leverage its process leadership in commercial grade AAV manufacturing. With two validated manufacturing sites on stream, the Company will be able to ensure it can supply commercial grade material for its pipeline of products as they advance into pivotal studies and will be positioned as the partner of choice for the manufacturing, development and commercialization of AAV-based gene therapies.
In connection with uniQure’s US expansion, the Company has appointed Lance Weed as VP US Operations. Mr. Weed was previously Executive Director, Site Operations at Amgen, and prior to that VP of Operations at BioVex Inc. Mr. Weed has extensive experience with the manufacturing of viral-based pharmaceuticals and oversaw the construction of Amgen’s (BioVex’s) launch grade viral vector manufacturing facility in Woburn, MA from scratch. He will join the Company on September 1.
In addition, uniQure raised USD 10 million in venture debt from Hercules Technology Growth Capital, Inc. to finance the build-out of the US plant, and for general working capital purposes.
“The construction of this facility represents our commitment to establishing a global, fully integrated gene therapy company as we continue to build on our leadership position in the field of AAV-based gene therapy products,” said Jörn Aldag, CEO of uniQure.