Midterm (Modules 2-7) Flashcards

1
Q

What are some differences between small molecules and biologics

A

biologics are large, unstable, usually injected, and made from living things, resulting sometimes in a heterogeneity

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2
Q

What are the steps of making recombinant DNA

A

I really like fucking people
Isolate
Restrict and ligage
fermentation
purification

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3
Q

What is the difference between biotechnology and biosciences

A

biotechnology is creating a product using living things and biology where as biosciences is the study of biology

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4
Q

What form of DNA is patentable

A

cDNA

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5
Q

What is cDNA

A

using reverse transcriptase, you can make a complementary stand of DNA that does not have any introns. This is considered not natural

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6
Q

Name 3 mechanisms of therapeutic action for mABs

A
  1. alter immune response
  2. trigger cell death
  3. disrupt signaling proteins
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7
Q

What are the two requirements from researchers before beginning a clinical trial

A

review and approval from IRB and file a IND with the FDA

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8
Q

How long is a typical patent for

A

6-10 years

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9
Q

What is pharmacogenetics

A

how someones genetics influences how they respond to drugs

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10
Q

what is pharmacokinetics

A

what the body does to the drug

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11
Q

what is pharmacodynamics

A

what the drug does to the body, think pharmaco-D what the DRUG DOES

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12
Q

What types of actions could drugs have?

A

work directly on the receptor, block mechanism of action, stablize action, direct harmful chemical to destroy cell, directly beneficial chemical

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13
Q

What is the largest group of biologics sales

A

monoclonal antibodies

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14
Q

what are some ways recombinant DNA can be uses

A

crops and GMOs, therapeutics,

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15
Q

What are some advantages of making proteins

A

can be produced in large amounts in a short amount of time,

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16
Q

What are some disadvantages of making proteins

A

multiple proteins can form aggregates, unstable, physical nature of some proteins can change theraputic nature

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17
Q

What is clinical research

A

research conducted with human subjects for which the investigator directly interacts with the subject

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18
Q

what are the critical issues with a cross over study

A
  1. the order in which treatments are administered
  2. the carry-over between treatments/wash out period
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19
Q

what is the IRB

A

the guardian of clinical research, reviews, protocols, informed consent, and the risk benefit ratio

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20
Q

what things are exempt from the IRB

A

Emergency use, anything with taste and food

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21
Q

What needs to be submitted to the FDA?

A

clinical research investigator, conditions of study, purpose, contact information

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22
Q

What is the process to initiate clinical trials?

A
  1. submit investigation of new drug application
  2. product must have potential benefit and be proven safe in preclinical models
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23
Q

What is -omics

A

a holistic approach to looking at what is going on in the cells

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24
Q

what is systems biology

A

the integration of different -omics to understand what is happening

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25
Q

define genomics

A

a persons genome

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26
Q

define metagenomics

A

genetic material directly from environment

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27
Q

define pharmacogenomics

A

study of genetic variation effect on drug response

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28
Q

define pharmacogenomics

A
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29
Q

define proteomics

A
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30
Q

define bioinformatics

A
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31
Q

What 3 groups make up proteins

A

the r-group, the carb

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32
Q

what form of structure in a protein offers its function

A

secondary structure

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33
Q

what happens in the primary structure

A

sequence of amino acids

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34
Q

what happens at the secondary structure

A

disulfide bonds forming alpha helices and beta sheets

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35
Q

what happens at the tertiary level

A

three dimensional folding

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36
Q

what happens at the quaternary level

A
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37
Q

what happens to proteins as you increase temperature or effect pH

A

Denaturing,

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38
Q

what is a competitive inhibitor

A

an inhibitor that competes with the substrate and there for slows it down

39
Q

what is an allosteric inhibitor

A

and inhibitor that binds to the enzyme and causes a change in shape to the enzyme, making it so the enzyme unable to bind to the substrate

40
Q

what was the first organism to have a compete genome sequenced?

A

a bacterium

41
Q

what was the first genetically modified organism?

A

a bacterium

42
Q

what are three important characteristics for a target protein

A

druggable,

43
Q

what current problems do we face in drug development

A
44
Q

what are some solutions to address current problems with drug development?

A
45
Q

what is the SBIR

A
46
Q

What is the SBA?

A
47
Q

what quality requirements are there in drug discovery?

A
48
Q

what are good practices?

A
49
Q

what are good manufacturing practices?

A
50
Q

what are good laboratory practices?

A
51
Q

what is the IHC and its role?

A
52
Q

molnupirav

A
53
Q

What is genetic engineering

A

direct manipulation of an organisms genome using biotechnology, also called genetic modification

54
Q

True or False: Restriction enzymes are not required for the genetic engineering process

A

false

55
Q

which organism was first genetically modified?

A

bacterium

56
Q

what omics includes structural biology, algorithms, and other disciplines?

A

bioinformatics

57
Q

This is used to optimize drug therapy with respect to the patients’ genotype, to ensure maximum efficacy with minimal adverse effects

A

pharmacogenomics

58
Q

what is the difference between the term genomics and genetics.

A

genetics is the science of heredity but genomics is the study of genes, their functions and all related technical aspects

59
Q

What organizations need to approve a genetically modifies organism for release?

A

USDA, FDA, and EPA

60
Q

True or false gene therapy can be applied to somatic but not germline cells

A

false

61
Q

What is the meaning of disease pivotal points? what are they important and when do we have to consider them?

A

these are points involved in the disease pathway and can regulate the disease, manipulation of these points can impact the disease, and we consider them during the discovery phase

62
Q

In dose escalation protocol, when is toxicity found?

A

when the max tolerated level is one level below the observed level

63
Q

what is the function of the IRB

A

to approve, disapprove, modify, and review biomedical and behavioral research involving humans

64
Q

what is one criteria for IRB approval?

A

informed consent and it is appropriately documented

65
Q

what is the process to initiate clinical trials?

A
66
Q

the decision on whether or not to approve a drug or not is based on

A

benefit vs risk assessment

67
Q

what are two incidents where IRB approval is exempt

A

emergency use and things involving food and taste

68
Q

how are clinical trials initiated

A

use of human subjects, IRB approval, and cooperation of clinical centers

69
Q

What characteristics would make a good choice as a target for a protein drug

A

a cell surface receptor and a cell surface receptor ligand

70
Q

What type of bond is the nitrogenous base linked to the ribose or deoxyribose sugar

A

glycosidic bond

71
Q

What adaptor is key to converting the triplet codons of mRNA into amino acids

A

tRNA

72
Q

What are some differences in prokaryotic and eukaroytic cells protein synthesis?

A
73
Q

what direction is mRNA translated

A

greatest to least, 5’ to 3’, start with the greatest

74
Q

what are 3 types of mutations which may affect DNA

A

point mutation, insertion, deletion

75
Q

Grants vs contracts

A
76
Q

What is IND

A
77
Q

what do you need for IRB approval?

A
78
Q

NIH vs NSF

A
79
Q

specific steps of transcription

A
80
Q

specific steps of translation

A
81
Q

what are some advantages of mRNA vaccines

A
82
Q

what are disadvantages of mRNA vaccines?

A
83
Q

how do mRNA vaccines differ from molnupirva

A
84
Q

How do enzymes work

A
85
Q

What are protein protein interactions?

A
86
Q

What are proteins

A

large molecules that contain fundamental biological and chemical components of all living organisms

87
Q

what is the largest family of targeted drugs

A

G protein coupled receptors

88
Q

what are 3 characteristics of clinical research

A
  1. seek to identify the most effective and most efficient interventions, treatments, and services
  2. Examine the distribution of disease, factors that affect health, and how people make health-related decisions
  3. Involves a particulare person or group of people or uses materials from human
89
Q

What is a crossover study?

A

administering two or more experimental therapies, one after another, in a specified or random order to the same group

90
Q

how do omics differ from not traditional studies

A

not hypothesis driven

91
Q

Why is cell culture technology important?

A

research, toxicity testing, gene therapy, genetic engineering, modeling systems

92
Q

What are some common mammalian cell lines?

A
93
Q

approach for genetic engineering of cell line

A

Identification of genes/proteins that are specifically up-regulated in bioprocessing conditions (-omics approach)
Engineering of cells and selection of a new cell line
Engineering of cells to over-express the gene(s) of interest (historical approach)
Examine the effect and select a new cell line
Further understanding of genes/pathways directly regulated by the gene of interest

94
Q

Bcl-2 over-expression

A

Increases cell viability
Prolongs culture duration
Reduces serum dependency
Improves nutrient metabolism
Protects cells in stressful conditions
Enhances adaptation in serum-free media