Choose Your Playing Field
So you want to build a new facility for advanced therapy manufacture? Before you start building, there is one essential element that you need to get right: site selection.
Grace Linton, Charles Heffernan |
sponsored by CRB
At first glance, the needs of an advanced therapy medicinal product (ATMP) facility may seem to be no different to those of a traditional bioprocessing facility – and indeed the clean rooms, testing and admin facilities will be very similar. Once you move into the commercial manufacture of ATMPs, however, more specific requirements will become apparent, particularly the “scale-out” rather than “scale-up” concept, gowning and segregation requirements, as well as community perception of the facility.
Building a facility that is fit for purpose begins with site selection. Your first choice is whether to build on a greenfield site – an undeveloped site with no pre-existing buildings – or fitout an existing shell building. It is common for companies to have surplus pharmaceutical manufacturing sites or warehouses that they wish to make use of, but in our experience, it can be difficult to optimize existing buildings for ATMP manufacture. With ATMPs, you need to consider expandability when creating the facility – how are you going to expand to accommodate future capacity as the business grows? This is particularly relevant for many autologous ATMP processes, since these can be manual and labor intensive, requiring additional space for expansion of capacity. These same limitations can apply to utility systems. If your space is constrained from the start by an existing building, then it can be tricky to truly optimize the facility.
One cell therapy client we worked with selected what seemed to be an appropriate site in an urban city block in New York, but the project came undone once they considered their liquid nitrogen distribution strategy. There was no space for bulk tank storage (space is always at a premium in big cities), so they had to consider the use of portable cylinders, but that meant there would be an enormous quantity of cylinders to move throughout the building. When moving liquid nitrogen in enclosed spaces, such as an elevator, you cannot have an operator in the same space because of asphyxiation hazards. You need to set up a shipping and receiving dock for the cylinders, and you need a way of getting them into the elevator and transporting them without a person. Additionally, you need to ensure everything is logged. Ultimately, it would have commandeered one or two elevators during shifts. And logistically that wasn’t going to work, so the site choice was abandoned. The client moved to another site where there was a shell of an existing warehouse that could be better designed to suit their needs. If you are opting for an interior fitout option, then try to ensure that the space selected allows for flexibility.
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