oa Editorial [Hot topic: GMP Production of Gene and Cell Therapy Therapeutics (Guest Editors: Manuel Carrondo and Pedro Cruz)]

As the successes of Gene Therapy trials become ever more frequent so does the need to develop production processes allowing faster transfer into the clinical development phases. The Gene Therapy field is significantly pulverised, with many different vectors being currently available. Furthermore, new developments on vector design and safety as well as in vector production and purification technologies raise new challenges for the GMP production of Gene Therapy products. This issue of Current Gene Therapy gathers the expertise of a number of partners from the CliniGene European Network of Excellence. Indeed, benefitting from the common ground gained as the CliniGene network strongly impacted the practise in the field, it became clear that such knowledge as created in CliniGene should be made available to the Gene Therapy community. In this issue the production of the most commonly used vectors - adeno-associated virus, adenovirus, gamma-retrovirus, lentivirus and non-viral vectors - is thoroughly addressed. The focus is on the current need for larger scale production and purification to ensure safety and efficacy of the most advanced technologies available. The vector production core of this special issue is flanked by two very important contributions. One introductory paper led by CliniGene's Network of Excellence Coordinator, Prof. Odile Cohen-Haguenauer, on how production facilities in Europe should be made to cooperate in a common infrastructure ensuring the progress of this therapy and a final paper on the design and operation of GMP facilities for Advanced Therapy Medicinal Products. As more innovative treatment solutions are proposed, improved technological innovations arise and thus more clinical trials guarantee more and better products, this issue attempts to depict the current state-of-the-art on the production of vectors for Gene Therapy clinical applications. Hopefully, this integrated volume will ensure a fast spread and harmonization of production processes, reducing the barriers to make Gene Therapy a successful deliverer of Advanced Therapy Medicinal Products (ATMP's).