Tag: <span>viral vector</span>

Technology-dependent industries such as biotechnology, nanotechnology, and digital signal processing rely heavily on patent law to secure protection for innovation and ensure returns adequate to sustain costly research and development programs. It can be a daunting task to stay current with patent law in the United States, and then throughout the world, the challenges increase exponentially. A case in point is the US, where significant patent law changes brought by the America Invents Act in 2011 are now being implemented. Beyond the revised US patent statute, seemingly lurking in the weeds, is the common law, also known as case or precedent law. One common law doctrine that can exert powerful influence over patent rights and economic behavior is the doctrine of patent exhaustion. In February 2013, the Supreme Court heard arguments in an especially relevant patent exhaustion case involving genetically modified plant seed via viral vector. The article will touch on this case and then move backward in time to review several historic court judgments that have played an integral part in shaping current interpretation of the law. Lastly, Bowman will be revisited…

Biologics Production

An increasing number of clinical trials, and the recent approval of the first gene therapy in Europe, alipogene tiparvovec (Glybera®, uniQure), holds promise for recombinant adeno-associated virus (rAAV) to become a mainstay in clinical practice. Since the molecular cloning of AAV in the 1980s, a plethora of production protocols/manufacturing systems for generating rAAV vectors have been developed. uniQure’s manufacturing platform, which has received validation through regulatory approval, is also capable of supporting industrial-scale production based on the baculovirus expression vector system (BEVS) and insect cells. In this paper, we review the molecular process optimization of the various components of uniQure’s rAAV production platform…

Biologics Production