
In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
uniQure B.V. announced it has commenced build-out of a 55,000 ft2 US manufacturing plant in Lexington, Mass.
The US site will 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, the company reports.
Source:
uniQure







