Excerpt

Cell and gene therapies are growing exponentially across the pharmaceutical field due to their potential to treat and possibly cure a wide range of devastating diseases, including cancer. As these therapies are becoming more wide spread, many drug sponsors are approaching trials with limited knowledge of how to design and launch a successful clinical trial manufacturing (CTM) process. This includes how to strategically investigate and manufacture adeno-associated virus vectors (AAVs) and lentiviral vectors (LVVs), two of the leading viral vectors used for gene therapeutics. Sponsors are faced with a stark learning curve that, without intervention, may lead to high costs, delays, and a failure to bring their drug to patients. …