Stem Cell products are extremely difficult to grow and produce. Pluristem holds many patents for processes and devices that would address the growth process as well as final dose production and filling. Such facilities have to adhere to stringent regulatory standards such as USFDA and EMEA.
The new facility is designed and constructed from scratch within an existing building. The project scope includes HVAC and clean rooms of the highest A and B classes, plant utilities, critical utilities, such as PuW, WFI and PS, as well as Buffer and Media production.
Pluristem is a start-up company and with this project takes a leap from the R&D stage to commercial-scale production. Being so, CAPEX as well as the OPEX optimisation are a major challenge for the designer, and it is extremely important to provide the client with these advantages. Furthermore, future expansion plans have to be addressed and the solution must facilitate a seamless future expansion.
Stem cells are currently the pinnacle of the biotechnology industry and, being a relatively new field, require special care as process and product are highly sensitive. The growth process is relatively long and may last a few weeks, which increases the risk and financial impact of batch loss due to any failure in the plant conditions.