Commercializing Advanced Therapy Medicinal Products (ATMPs) Manufacturing Processes

Meeting the dramatic increase in demand for viral vectors created by the rising number of gene therapy candidates progressing towards commercialization (particularly those that involve more patients receiving higher doses) presents a real challenge. Indeed, viral vectors are often criticized as being the key bottleneck in ATMP manufacturing and a main driver of cost for these therapeutic products. They can, in fact, account for as much as 40% of the cost of goods for gene and adoptive cell therapies (APMHE 61629).

Capacity shortages are a second hurdle that must be overcome. Some gene therapy developers are choosing to establish inhouse capacity to avoid the possibility of delays due to lack of manufacturing slots at contract development and manufacturing organizations (CDMOs). 

Manufacturers require novel technologies designed specifically to enable highly efficient and cost-effective upstream and downstream processing of viral vectors to enable the potential of gene and adoptive cell therapies to become a reality.