An artistic portrayal of adeno-associated viral vectors used in gene therapy manufacture

Advanced therapy medicinal product facilities through the eyes of a process architect

Advanced therapy medicinal product (ATMP) companies are ushering in a new frontier of medicine and technologies poised to revolutionize human health, but are ATMP facilities keeping up? The industry is advancing at such a rapid pace that these companies are faced with vast new complexities when developing and manufacturing their products.

Since the ATMP industry—also called cell and gene therapy—is in its early stages, many of the processes are new and still under development. In addition, fully automated, closed-processing equipment options are limited. As a result, manual, open processing is common, and the room environment becomes the layer of protection for the product. This translates to high classification of spaces and a long list of design considerations, such as proper wall thicknesses for low-wall returns, properly sized gowning rooms for different levels of required gowning, special finishes and details compatible with cleaning solvents, decontamination methods and so much more.

Involving a process architect during the initial planning stages will add value by integrating key strategies into the facility layout:

Scaling strategies

Cell and gene therapy companies could benefit from the early involvement of a process architect by properly designing the ATMP facility to support planned throughput increase. This is most impactful for autologous and personalized therapies since each batch is patient specific. For these facilities, the only way to increase production is to scale out by adding more production trains or suite modules. Circulation and egress strategies for multiple suites at full build-out must be established upfront. Sizing support spaces like the locker rooms and setting the corridor widths for supporting operations at full production mode is also critical. It is important to plan for corresponding expansion of functions supporting manufacturing, such as warehousing, waste staging and quality control laboratories.

Design for flexibility

The other challenging variable that ATMP or cell and gene therapy companies face is accommodating for future-proof design. As new technology comes out and processes are closed and automated, facility design and operations could change in significant ways.

Equipment technology for process closure will soon be a game-changer. When this occurs, allocation of space will change, subsequently altering design. For example, a recent project required Grade B processing suites because of a few open unit operations that couldn’t be closed with existing equipment technology. But once the closed processing equipment technology becomes available, this facility could change quite drastically—from removing air locks to potentially converting from unidirectional flow to bidirectional flow. In addition, more automated and less manual operations could result in a significant labor model shift, impacting the overall facility components, such as required parking spaces, locker rooms, administrative and amenity areas and size of gowning air locks. A process architect can anticipate these changes, and design the hallways, production suites and surrounding areas in a way that would provide maximum flexibility with minimal impact during a renovation.

Special design considerations

There is a wide range of products within the ATMP industry, and each product type comes with its unique challenges, such as containment and segregation strategies for viral vector production and heavy use of liquid nitrogen for cryopreservation in cell therapy. In the case of bulk liquid nitrogen, vacuum-insulated pipes for distribution can be very expensive, and poor placement of the liquid nitrogen tanks and cryopreservation freezers could be very costly.

Begin with the end in mind

Especially for ATMPs that are on a fast-track path to market, it is critical to have a clear vision and goal for the project and build a team that shares this vision and works toward the same goal. Bring the right people together for the early design meetings, especially a process architect. The right design firm will act as a partner and a contributor, challenging assumptions and proposing alternate solutions to provide you with a facility that meets your business goals, regulatory requirements and ultimately facilitates bringing life-saving therapies to patients.

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