Pluristem brings in Thermo Fisher to ‘transform cell therapy manufacturing’
Pluristem is a Haifa, Israel-based, developer of placenta-based cell therapy products that are entering late-stage trials; both its lead candidate, PLX-PAD, which is in development for the treatment of critical limb ischemia and hip fracture, and its treatment candidate, PLX-R18, have entered Phase III trials.
With these trials progressing through the clinic, the company has teamed up with Thermo Fischer in order to improve the efficiency with which it is able to manufacture the treatments before commercialising the products.
In particular, the press release states that the companies aim to “transform cell therapy manufacturing into a large-scale high capacity industry” and target the ability to produce “millions of therapeutic doses.”
A spokesperson for Pluristem explained where Thermo Fisher’s expertise will come into play: “Pluristem has the knowledge regarding the production needs, scale up and manufacturing process for cell therapy. We believe that our expertise combining with Thermo Fisher’s knowledge and experience in bioprocessing manufacturing, raw materials and supply chain will allow for new innovations that could lead to the scaling up of cell therapy manufacturing and distribution.”
Managing the manufacture of its cell therapies has been a long-running process of Pluristem, which has been developing its own standards in-house for over a decade.
As a result, it has become familiar with the main challenges of improving production and the spokesperson detailed what the company has found these to be: “The main challenges of production in high scale are: availability and quality of raw materials and their suitability for good manufacturing practice (GMP) manufacturing.”
The spokesperson continued: “There is also a need to develop new controlled and automated innovative technologies which will allow for high capacity and efficient manufacturing in order to change the art of growing cells into an industrial process. Another challenge is developing the distribution/delivery process for such unique and sensitive therapeutic products.”
