By Matt Niloff and Kristin Feerst
Speed plays an important role in the fight against COVID-19, and it is no less important for gene therapy. Unlike vaccines, however, being first to market is essential for most gene therapies. Early development stages are dominated by scientific discovery and laboratory scale investigations, but when accelerating the journey to clinical production, robust process development, de-risked scale-up, and efficient project management are needed to quickly enable a cost-effective manufacturing process.
Identifying fit-for-purpose technologies and the right implementation strategy from the outset are essential if the vision of the full-scale process is to be realized swiftly and without excessive risk. Critical to this vision are the operation of the hardware systems and how the individual unit operations will interconnect to ensure an optimal fluid flow path for the entire process. Supply chain and budgetary constraints are also very important considerations early in the project. To successfully address all these critical aspects of manufacturing start-up, it is imperative that the right solution is generated based on a clear understanding of the full process and project objectives. This is where the benefits of an integrated approach can apply.