G the crisis of h1n1 u vaccine in 2009 societal

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Unformatted text preview: tudies (1- 3 years). Exploratory •  First stage tes=ng in human subjects (~ 1 year). 20- 80 healthy volunteers •  Clinical trials (~ 2 years). 100- 300 pa=ents and volunteers •  Large clinical trials (~ 3 years). 300 – 3000 + pa=ents •  Post marke=ng surveillance trials Penicillin Alexander Fleming’s contaminated plate, 1928 http://fig.cox.miami.edu/~cmallery/255/255enz/penicillin.gif http://www.time.com/time/time100/scientist/profile/fleming.html A milestone in the history of human medicine by Alexander Fleming in 1928 •  An accidental discovery of an an=bio=c produced by a common mold of Penicillium notatum •  High demand of an=bio=cs during World War II •  Norman Heatley, a biochemist, op=mized the culture condi=on and recovery of the drug for animal and human tests •  Promising results obtained, but the material was exhausted resul=ng the death of a pa=ent How could penicillin be produced in large scale? •  US became the major player due to the absence of a war •  Merck, Pfizer, Squibb, and USDA Northern Regional Research Lab (USDA- NRRL) •  First idea (1940s)- chemical synthesis, turned out to be extremely difficult Produce penicillin by fermenta=on Major problem: low concentra=on of the product complicates the purifica=on process (0.001 g/L in 1939) Solu=ons: •  A new corn steep liquor- lactose based medium developed by USDA- NRRL (10x increase in yield) •  A beber strain for producing penicillin: Penicillium chrysogenum •  Fermenta=on process: change from surface method (“boble plant”) to submerged process – challenges in knowledge of mold physiology and tank design/control (steriliza=on, oxygen supply, heat removal) •  Purifica=on: Penicillin, as most of the biological products, is fragile (pH shins and liquid- liquid extrac=on) How was this archived •  Merck’s model: partnership of biologists and chemical engineers an interdisciplinary approach •  0.001 g/L (1939) - - - - - 50 g/L (1990) •  The birth of the concept of bioprocess engineering Penicillin Produc=on Process Bioprocess Engineering Biology Biotechnology Qualitative Descriptive Engineering Bioprocess Engineering Good at: Hypothesis testing Experimental design Quantitative Systematic Good at: Mathematical theory systematic analysis Process design control Bioprocess Engineering Molecular Sub-Cellular Cellular Cell to Cell Interaction Microenvironment Engineering content Macroenvironment (Bioreact...
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This note was uploaded on 01/20/2014 for the course CHE 489 taught by Professor Wang during the Spring '10 term at USC.

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