Early in our development as a company, we understood the need to develop the first tightly controlled, completely automated, efficient and scalable cell manufacturing technology in order to produce the highest quality cell therapy products on a commercial scale. We developed a state-of-the-art, proprietary bioreactor system which provides a three dimensional (3D) micro-environment for our cells that resembles the environment in the human body. As a result, our cells expand rapidly and remain healthy and potent as we alter conditions within our bioreactors to transform them into unique, patented cell therapy products. Our advanced manufacturing technology can generate cell products on a mass scale with batch-to-batch consistency, making them true commercial products.
3D culturing – Efficiency
70 Multi 10 Trays
1500 Multi 10 Trays
5L bioreactor with 150g scaffold
75L bioreactor with 2,000g scaffold
The PLX Bioreactor system is integrated into the world’s most advanced, automated and aseptic cell production facility, in which we can manufacture large quantities of cells of the highest quality in a cost-effective, reproducible and consistent manner. This capability is necessary for any cell therapy to become a true commercial product. Pluristem’s state-of-the-art manufacturing site is located in the MATAM industrial park in Haifa, Israel, and is equipped with 500m2 clean rooms with the capacity to manufacture cells to support clinical trials and initial commercial needs upon achieving marketing approval. Pluristem Therapeutics develops and manufactures its products in full compliance with international quality standards.
Regulatory and Compliance
Pluristem Therapeutics develops and manufactures its products in full compliance with international quality standards. Our Chemistry, Manufacturing, and Controls (CMC) for PLX cells have been approved by the FDA, EMA, PMDA, South Korean & Israeli regulatory agencies for culturing to supply cells for late stage clinical trials.