The pharmaceutical industry has been attracted to the gene therapy field and is starting to support clinical trials, establishing collaborative strategies to develop commercial products which in many cases are based on lentiviral vectors. The predictable widespread use of lentiviral vectors in next-generation gene therapy scenarios aimed at dealing with not only rare diseases raises important challenges and hurdles regarding their manufacture. The author reflects on this in the chapter on the state of the art in the manufacture of lentiviral vectors, addressing some current manufacturing processes, their achievements, and the uncertainties in ensuring a validated process capable of releasing consistent vector quality that meets global health authorities’ requirements. In summary, the proposal looks at the goals and challenges that must be addressed in manufacturing lentiviral vectors, in order to satisfy supply in the commercial stage, before we reach the next stage in gene therapy.
Part of the book: Systems Biology