Biotechnology Flashcards

1
Q

_____ is an exact copy of human hormone or other protein

A

first generation biopharmaceutical agent

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2
Q

_____ agent that is engineered

A

second generation biopharmaceutical agent

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3
Q

What are the options for second generation?

A
  • gene is altered before being transferred

- final product is manipulated

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4
Q

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

A
  • alter amino acid sequence
  • carbohydrate residue
  • covalent attachment of polyethylene glycol
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5
Q

____ the protein is specifically design to perform some function

A

third generation biopharmaceutical agent

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6
Q

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

A

biological product

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7
Q

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

A

biopharmaceutical

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8
Q

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

A

biotechnology

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9
Q

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

A

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

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10
Q

Challenges related to biopharmaceutical agents: (5)

A
  • refrigeration
  • methods for production, formulation, analysis, etc
  • different pharmacokinetics
  • immune response
  • production must be sufficient quantity
  • cost
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11
Q

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

A
  • Used to treat Hep C (interferon remains in the body longer)
  • Protects from enzyme degradation
  • Slows filtration through kidneys
  • Prevents antibody formation
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12
Q

What are some advantage of peglylation: (6)

A
  • Increase solubility
  • Reduces frequency of dosing
  • Extends circulation time
  • Increase stability
  • Protects from enzymes
  • Allow for companies to extend patent protection
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13
Q

T/F Therapeutic Proteins/Peptides CAN be administered orally

A

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

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14
Q

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

A
  • parenterally
  • intranasal
  • topical
  • pulmonary
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15
Q

Where are MOST therapeutic proteins administered?

A

parenterally

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16
Q

What are physical instabilities of therapeutic proteins? (5)

A
  • denaturation
  • association
  • aggregation
  • adsorption
  • precipitation
17
Q

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

A
  • Deamidation
  • Oxidation
  • Racemization
  • Proteolysis
  • Disulfide exchange