Biotechnology 3 Chapter 1 Review

studied byStudied by 19 people
5.0(1)
get a hint
hint

1950s

1 / 37

Tags and Description

Biology

thomy thumb told us to test on this

38 Terms

1

1950s

Structure of DNA described, as well as its method of replication

New cards
2

1970s

Advent of recombinant DNA technology began with isolation of restriction enzymes

New cards
3

Bioethics

The study of decision making as it applies to moral decisions that must be made due to advances \n in biology and technology.

New cards
4

ethical concerns with GMOs

  • cross-pollination with non-genetically modified crops

  • may decrease genetic diversity

New cards
5

benefits of genetically engineered human insulin

(versus insulin from animals)

  • less chance of immune response

  • avoids ethical issues of animal use

  • more efficient process

New cards
6

ethical concerns with CRISPR/Cas9 gene editing

alterations in germline cells will be passed onto future generations

New cards
7

Genomics

investigates the whole genome, the full complement of DNA in a cell

New cards
8

Proteomics

studies to proteome, the entire protein complement of a cell or organism

New cards
9

Transcriptomics

is a study of the transcriptome, every RNA transcript expressed in a cell or organism

New cards
10

Metabolomics

investigates the metabolome, all metabolites in a cell or organism present at a specific time

New cards
11

Microbiomics

investigates a microbiome, all microorganisms living in a place at the same time

New cards
12

Bioinformatics

a database of each of the “-omics” vast amounts of data

New cards
13

Biopharmaceuticals (biological drugs)

  • protein-based drugs

  • are produced by a living system

  • cannot be terminally sterilized using heat

  • are more sensitive to how they are handled in the manufacturing process

New cards
14

Bringing a Biopharmaceutical Product to Market

  1. Identifying a product

  2. Research and Development

  3. Clinical trials

  4. Manufacturing. Sales and Marketing

New cards
15

Disadvantage to using prokaryotes in the production of biopharmaceuticals

Prokaryotes are unable to \n properly fold and assemble more complicated eukaryotic proteins

New cards
16

Clinical Trials

Phase I – Phase with healthy volunteers or people with the disease/condition. The primary focus is on studying \n safety parameters of the drug. \n Phase II – Phase with volunteers who have the disease or condition. The primary focus is efficacy and \n determining side effects. \n Phase III – Phase with volunteers who have the disease or condition. The primary focus is a broad-scale study \n of the drug’s efficacy, and monitoring side effects.

New cards
17

Limitations of using biotechnology for pollution monitoring and waste management

  • Microbial activity may change with seasonal changes in temperature

  • Degraded waste byproducts may still be a major problem

  • New technologies might be more costly and take more time

  • Concerns regarding long-term outcomes from using genetically modified organisms

New cards
18

Quality Assurance (QA)

  • Oversees and ensures that all products meet \n standards of quality prior to being released \n for sale

  • Responsible for document control

New cards
19

Quality Control (QC)

Conducts testing on raw materials, in-process \n samples, and finished products using test \n records

New cards
20

Standard operating Procedure (SOP)

controlled document that contains step-by-step instructions on how to perform a routine activity within a company

New cards
21

Batch Record

contains step-by-step instructions on how to manufacture a product, including spaces for capturing information specific to the task

New cards
22

Assay Validation

describes the process of providing documented evidence that a method does what it is intended to do

New cards
23

Test Record

contains step-by-step instructions on how to test a raw material or a product, including spaces for capturing information specific to the task

New cards
24

Informed Consent

process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention

New cards
25

STEPS IN PRODUCTION

  1. Quality Control tests, and approves or rejects raw materials, following test records.

  2. Manufacturing produces the product following a batch record.

  3. Quality Control tests the final product following test records.

  4. Quality Assurance approves or rejects the final product based on final product specifications

New cards
26

patents last for

20 years

New cards
27

The Food and Drug Administration (FDA)

ensures that food and beverages are safe for human consumption and that therapeutic drugs and devices are safe and effective. Also, responsible for regulating \n biopharmaceuticals for use in humans, regulate cGLPs and cGMPs

New cards
28

The Occupational Safety and Health Administration (OSHA)

responsible for regulations pertaining to worker \n safety

New cards
29

The Environmental Protection Agency (EPA)

protection of human health and the environment

New cards
30

The U.S. Department of Agriculture (USDA)

ensures that agriculture and livestock are protected

New cards
31

Food, Drug, and Cosmetic Act

tightened controls over drugs and food, included new consumer protection against unlawful cosmetics and medical devices, and enhanced the government's ability to enforce the law

New cards
32

Genetic Information Nondiscrimination Act

prohibits bias that is based on information derived from DNA testing

New cards
33

Pure Food and Drugs Act

prohibited the sale of misbranded or adulterated food and drugs

New cards
34

21st Century Cures Act

designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently

New cards
35

Good Laboratory Practice (cGLP)

a quality system with a set of regulated practices used to collect safety data on a drug or product being developed (non-clinical/ pre-clinical) to ensure regulatory compliance in laboratory studies. (FDA oversight)

New cards
36

Good Clinical Practice (GCP)

a quality system used by governments to establish their own regulations for clinical trials involving human subjects (FDA oversight)

New cards
37

Good Manufacturing Practice (cGMP)

a quality system with a set of standardized practices that ensure steps are taken to produce consistently safe and effective products. (FDA oversight)

New cards
38

Good Documentation Practice (cGDP)

the guidelines that one follows in recording raw data entries in a legible, traceable and reproducible manner (part of cGMP). (FDA oversight)

New cards

Explore top notes

note Note
studied byStudied by 3 people
Updated ... ago
5.0 Stars(1)
note Note
studied byStudied by 14 people
Updated ... ago
5.0 Stars(1)
note Note
studied byStudied by 24 people
Updated ... ago
5.0 Stars(1)
note Note
studied byStudied by 17 people
Updated ... ago
5.0 Stars(1)
note Note
studied byStudied by 9 people
Updated ... ago
5.0 Stars(1)
note Note
studied byStudied by 252 people
Updated ... ago
5.0 Stars(9)
note Note
studied byStudied by 13 people
Updated ... ago
5.0 Stars(1)
note Note
studied byStudied by 21 people
Updated ... ago
5.0 Stars(2)

Explore top flashcards

flashcards Flashcard20 terms
studied byStudied by 9 people
Updated ... ago
5.0 Stars(1)
flashcards Flashcard52 terms
studied byStudied by 4 people
Updated ... ago
5.0 Stars(1)
flashcards Flashcard56 terms
studied byStudied by 14 people
Updated ... ago
5.0 Stars(1)
flashcards Flashcard67 terms
studied byStudied by 17 people
Updated ... ago
5.0 Stars(1)
flashcards Flashcard40 terms
studied byStudied by 19 people
Updated ... ago
4.0 Stars(1)
flashcards Flashcard23 terms
studied byStudied by 62 people
Updated ... ago
5.0 Stars(1)
flashcards Flashcard20 terms
studied byStudied by 4 people
Updated ... ago
5.0 Stars(1)
flashcards Flashcard78 terms
studied byStudied by 18 people
Updated ... ago
5.0 Stars(1)