Group project criteria

Criteria for Group Project Presentation

During your presentation you have 15 minutes to cover the following subjects:

1. BP product description

a. Which class of BP does your product belong to and how was the nonproprietary name

obtained?

b. What is the active drug substance and how does it exert its therapeutic activity?

c. What is the dosage form and via which route of administration does it need to be given

to a patient?

d. For which indications can it be used and how does this product compare to other drug

products on the market for the intended indication(s)?

2. BP product manufacturing (upstream processing)

a. Origen of the sequence that was used to clone the gene of the drug substance

b. Information on restriction enzymes/PCR protocols that were used for cloning

c. Information of the cloning and expression vector that was used to subsequently generate

the gene construct and express it into producer cells

d. Information on the type of cells used

e. The procedure how a high expressing clone was selected

f. Information of how the master cell bank was generated

g. Information on the culture medium used for production and whether cells were grown as

suspension cells or adhered to solid supports

h. Information on the type of bioreactor used, seed train and final scale of production

3. BP product purification & formulation (downstream processing)

a. Explain the development of your product: explain the choice of separation techniques

(downstream processing).

b. Discuss potential stability and formulation issues of your product

c. Choose a final formulation (liquid vs. solid, dosage form, excipients selection) and the

role of the formulation (excipients) found in the drug?

4. BP product quality and safety

a. Describe what the manufacturer of your product has done to guarantee consistency in

manufacturing of the BP and the safe use in humans

b. Describe the analytical techniques that were used to guarantee purity and safety of the

drug substance

c. Describe what the shelf life of the drug product is and how it should be stored to

guarantee safe use

5. BP product application & use

a. Describe the route of administration of the BP product, dose and dosing scheme

b. Describe how the active substance reaches its site of action. Also describe how efficient

this process is

c. Mention the molecular target and where it is located

d. Describe and explain possible side effects (including immunogenicity) that have been

observed with your BP product. Also describe how frequent/rare these side effects are and

how these can be explained/overcome

6. Economics and Ethics

a. What is the (estimated) price of this drug and is it available to patients in the

Netherlands?

b. What can you find on the decision on reimbursing this drug?

c. Do you think this drug should be used or are there other (better/cheaper) drugs

available?

Updated January 2020

Vaardigheden (FA-BA-100)

Universiteit Utrecht

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