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Abstract            Volume:5  Issue-6  Year-2017         Original Research Articles

Online ISSN : 2347 - 3215
Issues : 12 per year
Publisher : Excellent Publishers
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Pre-clinical Safety Evaluation of Recombinant Human Granulocyte Macrophage Colony Stimulating Factor (rh GM-CSF)
Bajji Chitra1,2*, Durga Bhavani Konga1, Pavan Kumar Manikonda1, P. Sudhakar2, K.R.S. Sambha Siva Rao2 and Murali Krishna Reddy Tummuru1
1Virchow Research Center, Hyderabad, INDIA - 500 043, India
2Depeartment of Biotechnology, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur-522510
*Corresponding author

Granulocyte-macrophage colony-stimulating factor (GM-CSF), a monomeric glycoprotein produced by macrophages, T cells, mast cells and NK cells naturally. Since, this cytokine is responsible for the survival, proliferation, differentiation and function of myeloid cells, it has been used in vast applications such as cancer and inflammatory diseases. There is huge requirement of this therapeutic drug, recombinant human GM-CSF (rhGM-CSF) has been developed in yeast cells and characterized by various biophysical properties by the present investigators using rDNA technology. The rhGM-CSF has been increased the yield by expressing with T7 promoter and downstream of pelB signal peptide (2.5 kDa) in yeast cells and it can be used as a therapeutic protein where it shows the similar biochemical properties with natural human rhGM-CSF protein (Chitra et al., 2017). Further, to characterize any toxicological symptoms that might be produced in animals and to find recommended dose levels of rhGM-CSF for using as a therapeutic drug, the present investigation has been focused. Acute, sub-acute and chronic toxicity tests are routinely carried out by various pharmaceutical companies in the development of new medicines. Initially, acute study was conducted by administering ten times of the therapeutic dose of rhGM-CSF to mice and observed for 15 days to find the pre-terminal morbidity, mortality and any toxic reactions. There are no significant toxicological symptoms or any other adverse reactions observed during the sub chronic study in all males and females, it indicating that rhGM-CSF is safe up to the 325 µg/ 20 g mice and 116.6 µg/kg rabbit dose level. Based on these results, the present investigation suggested rhGM-CSF is safe and further conducting the clinical studies might be helpful for using the rhGM-CSF as a therapeutic drug.

Keywords: GM-CSF: Granulocyte-macrophage colony-stimulating factor, Acute toxicity, Sub-chronic toxicity study, Recombinant DNA technology, Clinical chemistry, Hematology.
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How to cite this article:

Bajji Chitra, Durga Bhavani Konga, Pavan Kumar Manikonda, P. Sudhakar, K.R.S. Sambha Siva Rao, Murali Krishna Reddy Tummuru. 2017. Pre-clinical Safety Evaluation of Recombinant Human Granulocyte Macrophage Colony Stimulating Factor (rh GM-CSF).Int.J.Curr.Res.Aca.Rev. 5(6): 28-37
doi: https://doi.org/10.20546/ijcrar.2017.506.004
Copyright: This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike license.