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Team:Wageningen UR/Safety of the Application
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Revision as of 06:03, 16 September 2013
- Safety introduction
- General safety
- Fungi-related safety
- Biosafety Regulation
- Safety Improvement Suggestions
- Safety of the Application
Safety of the application
Lovastatin is a compound used in medicines used in lowering LDL cholesterol for patients suffering cardiovascular disease[1]. At this moment it is produced in Aspergillus terreus which produces toxins at the same time. Since it is undesirable to produce toxins at the same time as production of lovastatin, a new production host is needed. Aspergillus niger as a mass producer of organic acids and heterologous proteins. The products produced by A. niger have a GRAS (Generally Recognized As Safe) status, which makes it an ideal candidate for lovastatin production
According to OSHA and ANSI, Material Safety Data Sheet (MSDS) of lovastatin is obtained. Lovastatin as the end-product is non-replicative and contains no genetic material. Nevertheless, anything that is going to be used as medicine compounds will first have to undergo rigorous clinical trials.
Different secondary metabolites will, of course, have their own safety-issues related to them. Especially when producing novel compounds it will be nearly impossible to assess the safety of the compound a priori.
On a the scale of the bioreactor, having a single cell rather than a mycelial phenotype will change the behaviour of the system by reducing viscosity and diffusional limitation. Input, such as stirrer power and gas flow rates, have to be checked to prevent flooding. For the lower limit the Froude criterion applies:
This is lower limit of the stirrer power needed to disperse the required amount of bubbles. Using the gas flow rate and given stirrer power, we can find the gas holdup and thereby the gas volume.
1.Muldoon, M.F., et al., Effects of lovastatin on cognitive function and psychological well-being. The American journal of medicine, 2000. 108(7): p. 538-546.
