4. (20 points) hEGF Bioproduction Assume that you have been assigmed to a team t

Question

4. (20 points) hEGF Bioproduction Assume that you have been assigmed to a team to produce human epidermal growth factor (hEGF). A small peptide, hEGF, speeds wound healing and may be useful in treating ulcers. A market size of 50 to 500 kg/yr has been estimated. Posttranslational modifications are not essential to the value of the product. It is a secreted product in the natural host cell Briefly discuss what recommendations you would make to the molecular biology team leader for (1) the choice of the host cell and (2) the design of a bioreactor to produce the product. How and why would you formulate the drug for delivery to patients?

Explanation / Answer

1) The choice of host cell are Epidermal Growth Factor ,MTT,NIH 3T3 Cells

Dialysis after urea solubilization caused precipitation fo unwanted proteins ,resulting in achivement of purified EGF with >90 % purity, without the need for expensive and time consuming process. The MTT assay results showed that our rhEGF activate significantly higher proliferation of NIH 3T3 cells in comparision to the control (p values were < 0.0001),in total concentration and times evaluated

conclution : a sufficient amount of biaactive recombinant human epidermal growth factor was obtained in just a few affortable steps with superlatiove purity .

2)To produce 50 to 500 kg /yeat A bioreactor may also refer to a device or system meant to grow cells ,tissues in the context of cell culture .

As of now pioneering work shimizu et al(1991) described developed a fed batch procedure for recombinant EGF production .The EGF produced remained inside the microbial cell .It is that recombinat produce be excreated into the cell growth medium .

Formulate the drug

Double blind controlled clinical study to compare intravenous human epidermal growth factor (hEGF) to cetraxate hydrochloride ,an antiulcer drug ,for their healing effect on gastric ulcers .In the clinical trial ,the rate of ulcer healing within 8 weeks was 77.9% in patients receiving 6 micrograms EGF intravenously twice week ,being significantly geather than 51.7% in those givenCH.Taking together all aspects assessed including the healing rate ,pain relief , blood examination and adverse reaction .we judge the hEGF to be a useful and safe anticuler drug .

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