Site Design Considerations for Cell and Gene Therapy Commercial Facilities
Over the past decade, cell and gene therapies (CGTs) have gained traction in manifesting their promise to offer therapies for diseases previously untreatable by traditional means. The promise of cell and gene therapies was not only to address unmet clinical needs but to tackle the entire gamut of debilitating diseases, ageing-related disorders, degeneration and permanent damage to organ systems by enabling a regenerative approach and correcting deficiencies at the molecular and genetic level. Widespread efforts in research and development of CGTs over the past few decades have paved way to overcome the technical challenges and develop methods and tools required for clinical and commercial implementation of these therapies. CGTs have started to emerge in the commercial space and will gain momentum over the next 1-2 decades with surges in a large number of new therapies requiring clinical and commercial manufacturing.
In this presentation, we will broadly categorize the different types of CGTs, define the typical manufacturing process and how that affects equipment selection. Deriving from current commercial manufacturing plants, we will then take a closer look at the major pieces of equipment, instruments, and their role in the process. To understand implications for site design, we will next explore how the CGT equipment connect to each other, product flows, any operation considerations and special utility requirements. We will conclude by dabbing our feet into the evolution and transition of technologies, equipment and sites that are taking place, and the outlook on what the next generation facility should look like that pharmaceutical companies and CMOs may anticipate as they evaluate their construction plans for clinical and commercial manufacturing.
The State of the Plant Based and Cultured Meat Products Industry:
This presentation examines the current market of cultured and plant-based foods and the anticipated growth to displace the global consumption of conventional meat. The demand for plant and cultured meat products continues to grow and companies pursue high-throughput facility capacities to find a profitable economy of scale. As product biochemistry advances, factors such as taste, texture, perception, and consumer price point all impact commodity optimization. While facility designs and locations are driven by traditional factors of investment capital, resource availability, and future expansion goals, the cultured and plant-based meat industry straddles the line between global and regional codes and regulations. This industry remains in its infancy. New standards for food-grade cleanliness, product integrity, and consumer perception are emerging. Companies pursue global market share and capital and operational design efficiencies while aspiring to overcome the pitfalls of raw materials-to-product economics, regulatory and consumer perception, and cost-prohibitive facility designs.
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