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Pharmaceutics Spring 2016 > Biotechnology > Flashcards

Flashcards in Biotechnology Deck (17)
1

_____ is an exact copy of human hormone or other protein

first generation biopharmaceutical agent

2

_____ agent that is engineered

second generation biopharmaceutical agent

3

What are the options for second generation?

-gene is altered before being transferred
-final product is manipulated

4

What are some examples of second generation final product manipulation? (3)

-alter amino acid sequence
-carbohydrate residue
-covalent attachment of polyethylene glycol

5

____ the protein is specifically design to perform some function

third generation biopharmaceutical agent

6

______ means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein

biological product

7

_______ substances produced in living systems by biotechnology and used for therapeutic or in vivo diagnostic purposes.

biopharmaceutical

8

______ any technique that uses living organisms (or part of) in the production or modification of products.

biotechnology

9

Why is there such a large growth in protein therapeutics? (4)

o Increases in research and development spending
o Advances in technology
o Patent expirations
o Rising competition

10

Challenges related to biopharmaceutical agents: (5)

-refrigeration
-methods for production, formulation, analysis, etc
-different pharmacokinetics
-immune response
-production must be sufficient quantity
-cost

11

Peginterferon alfa-2b (agent is interferon) (4)

• Used to treat Hep C (interferon remains in the body longer)
• Protects from enzyme degradation
• Slows filtration through kidneys
• Prevents antibody formation

12

What are some advantage of peglylation: (6)

• Increase solubility
• Reduces frequency of dosing
• Extends circulation time
• Increase stability
• Protects from enzymes
• Allow for companies to extend patent protection

13

T/F Therapeutic Proteins/Peptides CAN be administered orally

FALSE: can not because they are proteins and peptides (enzymes in the GI tract would destroy them)

14

What are the routes of administration for therapeutic proteins/peptides?

-parenterally
-intranasal
-topical
-pulmonary

15

Where are MOST therapeutic proteins administered?

parenterally

16

What are physical instabilities of therapeutic proteins? (5)

-denaturation
-association
-aggregation
-adsorption
-precipitation

17

What are chemical degradation instabilities of therapeutic proteins? (5)

-Deamidation
-Oxidation
-Racemization
-Proteolysis
-Disulfide exchange