Things to Know for Biopharmaceuticals

Things to Know for Biopharmaceuticals Name one biopharmaceutical made from a microorganism Biopharmaceutical: _____________________________________________________ Microorganism: _____________________________________________________ Name one biopharmaceutical made from an animal cell Biopharmaceutical: _____________________________________________________ Animal cell: _____________________________________________________ Most proteins used as biopharmaceuticals are (primary/secondary) metabolites of the growth of microorganisms. Consequently, they are (growth/non-growth)-related metabolites. center283210 Label the phases of microbial growth on the following graphs. Write a mathematical expression to calculate the following terms, from fermentation data of X versus t (number of cells versus fermentation time), assuming that the initial substrate concentration was So and that the initial cell concentration was Xo: Growth rate Average growth rate at time t Maximum specific growth rate Maximum growth rate Overall average growth rate Doubling time Yield of growth with respect to substrate used for that growth Productivity of a product P at time t Overall productivity (for product P) You want to produce a biopharmaceutical from an animal cell. Would you use a totipotent cell line, a pluripotent cell line or a multipotent cell line? Name at least three “bioreactor” conditions that must be met to grow Immortal cells Differentiated cells Name the location(s) where microbial, animal or plant cells produce: Proteins Glycoproteins Sialylated “structures” Name one equipment to Harvest microbial cells from the culture medium Disrupt microbial cells Purify a protein from sugars and salts, based on its size alone Purify a protein from many recovered, based on its charge and size Purify a protein from many recovered, based on its biological activity Separate an enzyme from its stereoisomer Separate a glycoprotein from other recovered proteins What is a glycoprotein and the level of architecture (primary, secondary, tertiary, or quaternary) for its structure? Explain whether a temperature of -50°C negatively affects a protein. The thermal death rate (D-value) of a microorganism is 270 minutes at 85°C. After recovering a soluble extracellular protein from the culture, sterilization at 121.1°C must be done to reduce the microbial population by a factor of 12. Calculate the sterilizing value needed as the reference for an autoclave sterilization. You may assume that the z-value is 10. What is the difference between activity, purity and yield for a recombinant protein produced in plant cells? How heavy is a kDa?