I: Questions

Question 1

What two types of cells are combined during the production of a hybridoma cell line for monoclonal antibody production?

Answer 1

A B-cell from a nouse immunised with the antigen of interest and a myeloma (cancer) cell line.

Question 2

Name a suitable recombinant expression system to produce a
glycoprotein biopharmaceutical in which the glycan chains are necessary for biological activity?

Answer 2

Mammalian cells: Chinese hamster ovary and baby hamster kidney.

Question 3

Administration of a protein-based biopharmaceutical to a patient may generally not be performed via the oral route. Briefly, provide two reasons which prevent oral administration of such biopharmaceuticals?

Answer 3

A protein drug will be digested by stomach acid/enzymes before entry into the small intestine; protein drugs have hydrophilic character on exterior, not suited to passage across the more hydrophobic membrane of the small intestine (and so poor absorption).

Question 4

Name one mammalian cell line commonly used for production of biopharmaceuticals for human medical use?

Answer 4

Chinese hamster ovary; baby hamster kidney.

Question 5

Provide two disadvantages of producing human therapeutic proteins in mammalian cell lines?

Answer 5

Complex nutritional requirements (costly); potential contaminants from growth medium ingredients (such as prions); slow growth; more susceptible to bacterial contamination.

Question 6

Discriminate between a master cell bank and a working cell bank?

Answer 6

The master cell bank is prepared after an organism has been optimised in the research lab (e.g. mutagenised, rDNA procedures, medium adapted etc.). the working cell bank is derived from the MCB and is used in actual production runs in a manufacturing plant. Both are held in frozen cell aliquots in a cryoprotectant.

Question 7

What class of drug is Rituximab and what is its therapeutic use?

Answer 7

Monoclonal antibody used to treat B-cell lymphoma.

Question 8

What class of drug is Herceptin and what is its therapeutic use?

Answer 8

Monoclonal antibody used to treat certain types of breast cancer and lymphomas. It targets the HER2 receptor (over-expression associated with increased cell growth).