Good Manufacturing Practice (GMP) for Cell Therapy Manufacturing: What does this mean?

Friday, April 14, 2017 - 14:29
gmp cytokines and growth factor use in cell therapy process

 

Several suppliers, including R&D Systems, offer growth factors and cytokines made specifically for culturing cells that will be used for cell therapy. They are only to be used during the cell culture process and residual protein is washed away before the cells actually come into contact with a patient. These reagents are commonly referred to as GMP (Good Manufacturing Practice), a term that has traditionally been reserved for materials made with oversite from federal regulatory authorities like the FDA. Despite the GMP label, this class of reagent receives no such regulatory oversite.

So what does GMP actually mean in this context? There are some guidelines, but unfortunately, there can be differences among suppliers about what the definition of GMP actually is. It is up to the cell therapy manufacturer to define what is important to them.

A new article provides more detail about the definition of GMP and highlights some of the most important qualities you should expect from suppliers.

Read more on The Cell Culture Dish: GMP Proteins for Cell Therapy Manufacturing

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