GMP growth factors and cytokines designed for therapeutic manufacturing are an essential component of defined media. To date, the cell therapy industry has accepted GMP terms for this reagent class, despite the fact that there is no direct oversight by regulators. These proteins are intended for use in further manufacturing processes and do not come into direct contact with patients. In fact, cell therapy manufacturers need to take steps to ensure that reagents used for further manufacturing are removed before the cells are used in the clinic.

Transition Program for GMP Cytokines - For each cytokine, Creative Bioarray provides a certificate of analysis, stability data, and bioactivity documentation for comparison to research-grade cytokines. Customer confirms that GMP-grade cytokines of interest are produced by the same cloning and manufacturing process as research-grade cytokines. Subsequently, Creative Bioarray provided three lots of each GMP cytokine for performance equivalence and lot-to-lot consistency testing.

Product transitions from research-use products to cGMP manufacturing are easiest if GMP is available from the same supplier that provides the research-use-only (RUO) protein. Despite more stringent manufacturing processes and analytical testing, there may be little variation between proteins in vials. It's perfectly valid to ask whether the manufacturing steps and materials used are essentially the same. If a GMP version is not available, some suppliers will do a custom project to manufacture your protein using GMP guidelines. Even though the transition should be seamless in these cases, confirmatory testing should be done with repeated experiments.

In order to make the cells grow well in the serum-free medium, a certain amount of appropriate cytokines, such as EPO, NGF, PDGF, EGF, M-CSF, etc., must be added. Serum-free medium needs to be free of virus contamination, animal-free, stable between batches, etc. Therefore, the cytokines that can be used for its addition must also be animal-free, low endotoxin, and have good stability between batches. That's why GMP-grade cytokines are getting so much attention.

In order to be better used in cell research and drug development, GMP-grade cytokines adopt a humanized expression system, and the source is free of mycoplasma and virus contamination. HEK293 cells with a good safety record, after a long period of screening, have obtained HEK293F cells that are easy to transfect and can express a large amount of the target protein.

The cell culture medium for GMP-grade cytokine production adopts serum-free, protein-free, chemically defined SMM293 medium to avoid the influence of complex protein components in serum, and the purity of the recombinant protein produced can reach more than 97% by SDS-PAGE , and there is no animal-derived protein contamination such as animal albumin and animal transferrin.

GMP-grade cytokines have low endotoxin, no mycoplasma and virus contamination, and no other carrier proteins, which can achieve large-scale production, reduce costs, and ensure product stability.

It is precisely because of these excellent characteristics that GMP-grade cytokines have been widely used in the cultivation and differentiation of cells in clinical research and the preparation of high-demand cell culture media. It also shows its talents in the application of preclinical research, especially in the research and development and production of new drugs, and the scope of application in stem cell and cell therapy research is also constantly expanding.