Midterm (Modules 2-7) Flashcards by Meghan Wilkinson

What are some differences between small molecules and biologics

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

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What are the steps of making recombinant DNA

I really like fucking people
Isolate
Restrict and ligage
fermentation
purification

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What is the difference between biotechnology and biosciences

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

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What form of DNA is patentable

cDNA

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What is cDNA

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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Name 3 mechanisms of therapeutic action for mABs

alter immune response
trigger cell death
disrupt signaling proteins

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

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

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How long is a typical patent for

6-10 years

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What is pharmacogenetics

how someones genetics influences how they respond to drugs

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what is pharmacokinetics

what the body does to the drug

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what is pharmacodynamics

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

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What types of actions could drugs have?

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

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What is the largest group of biologics sales

monoclonal antibodies

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what are some ways recombinant DNA can be uses

crops and GMOs, therapeutics,

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What are some advantages of making proteins

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

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What are some disadvantages of making proteins

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

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What is clinical research

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

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what are the critical issues with a cross over study

the order in which treatments are administered
the carry-over between treatments/wash out period

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what is the IRB

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

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what things are exempt from the IRB

Emergency use, anything with taste and food

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What needs to be submitted to the FDA?

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

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What is the process to initiate clinical trials?

submit investigation of new drug application
product must have potential benefit and be proven safe in preclinical models

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What is -omics

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

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what is systems biology

the integration of different -omics to understand what is happening

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define genomics

a persons genome

define metagenomics

genetic material directly from environment

define pharmacogenomics

study of genetic variation effect on drug response

define pharmacogenomics

define proteomics

define bioinformatics

What 3 groups make up proteins

the r-group, the carb

what form of structure in a protein offers its function

secondary structure

what happens in the primary structure

sequence of amino acids

what happens at the secondary structure

disulfide bonds forming alpha helices and beta sheets

what happens at the tertiary level

three dimensional folding

what happens at the quaternary level

what happens to proteins as you increase temperature or effect pH

Denaturing,

what is a competitive inhibitor

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

what is an allosteric inhibitor

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

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

a bacterium

what was the first genetically modified organism?

a bacterium

what are three important characteristics for a target protein

druggable,

what current problems do we face in drug development

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

what is the SBIR

What is the SBA?

what quality requirements are there in drug discovery?

what are good practices?

what are good manufacturing practices?

what are good laboratory practices?

what is the IHC and its role?

molnupirav

What is genetic engineering

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

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

false

which organism was first genetically modified?

bacterium

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

bioinformatics

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

pharmacogenomics

what is the difference between the term genomics and genetics.

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

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

USDA, FDA, and EPA

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

false

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

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

In dose escalation protocol, when is toxicity found?

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

what is the function of the IRB

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

what is one criteria for IRB approval?

informed consent and it is appropriately documented

what is the process to initiate clinical trials?

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

benefit vs risk assessment

what are two incidents where IRB approval is exempt

emergency use and things involving food and taste

how are clinical trials initiated

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

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

a cell surface receptor and a cell surface receptor ligand

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

glycosidic bond

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

tRNA

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

what direction is mRNA translated

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

what are 3 types of mutations which may affect DNA

point mutation, insertion, deletion

Grants vs contracts

What is IND

what do you need for IRB approval?

NIH vs NSF

specific steps of transcription

specific steps of translation

what are some advantages of mRNA vaccines

what are disadvantages of mRNA vaccines?

how do mRNA vaccines differ from molnupirva

How do enzymes work

What are protein protein interactions?

What are proteins

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

what is the largest family of targeted drugs

G protein coupled receptors

what are 3 characteristics of clinical research

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

What is a crossover study?

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

how do omics differ from not traditional studies

not hypothesis driven

Why is cell culture technology important?

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

What are some common mammalian cell lines?

approach for genetic engineering of cell line

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

Bcl-2 over-expression

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

Midterm (Modules 2-7) Flashcards

(94 cards)