Comparison of 2 processes

Question 1

bacterial vs mammalian

Answer 1

large scale manufacture of recombinant protein in mammalian cells is more profitable

Question 2

Recombinant Human erythropoietin key points

Answer 2

formed from CHO cells since it is a glycoprotein
monomer, 18.46 kDa
166 AA
Used to treat anaemia caused by kidney disease or chemotherapy. stimulates RBC production

Question 3

typical protocol for purifying erythropoietin

Answer 3

cell culture, remove cells ( centrifuge & filtration), affinity chromatography, ion exchange chromatography, reversed phase chromatography

Question 4

post 1980 biopharma products

Answer 4

therapeutic proteins, monoclonal antibodies, designer proteins

Question 5

monoclonal antibodies

Answer 5

made up of 2 chains, heavy & light

Use: wide range of uses, anti- cancer & anti-arthritis treatments

Question 6

monoclonal structure

Answer 6

cannot be produced in a CSTR, therefore should be produced in a mammalian cell

Question 7

designer therapeutic proteins

Answer 7

Enbrel. dimeric fusion protein. consists of extracellular ligand binding. used for anti-arthritis treatment
large therefore cannot be produced by a microbial system

Question 8

mammalian cell culture pros & cons

Answer 8

pros- glycolysate proteins, fold large proteins, secrete proteins into the media.
cons- slow, shear sensitive, stringent media requirements

Question 9

fed batch single use

Answer 9

whole cell culture rxn is done in a single bag which is then disposed off. reactors don’t have to be cleaned at the end, increases efficiency. operates at controlled temp, ph & 02 level

Question 10

viral filtration

Answer 10

filters virus particles out of product stream

Question 11

viral inactivation

Answer 11

to eliminate viruses ie. by creating a low pH atmosphere