Present Situation of Viral Vector Manufacturing and Ways to Overcome Potential Barriers in View of the Routine Large Scale Production and Use of Viral Vectors

Abstract

The marketing authorization of two gene therapy treatments in Europe has opened the door to routine manufacturing of viral vectors, in particular, of MLV, LV, and AAV vectors, meaning that a quantum leap in routine manufacturing technology will be necessary in order to be able to produce the required quantities. However, this quantum leap is already required for producing the vector amounts necessary for performing advanced clinical trials, in particular, with respect to neuromuscular diseases (NMDs), such as Duchene Muscular Dystrophy (DMD). This review presents briefly the actual situation of the production of the most important viral vectors (AV, MLV, LV, and AAV) and barriers to be overcome in view of the large scale manufacturing of these vectors for routine use.