Biotechnology 3 Chapter 1 Review

thomy thumb told us to test on this

1950s

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

1970s

Advent of recombinant DNA technology began with isolation of restriction enzymes

Bioethics

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

ethical concerns with GMOs

* cross-pollination with non-genetically modified crops
* may decrease genetic diversity

benefits of genetically engineered human insulin

(versus insulin from animals)

* less chance of immune response
* avoids ethical issues of animal use
* more efficient process

ethical concerns with CRISPR/Cas9 gene editing

alterations in germline cells will be passed onto future generations

Genomics

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

Proteomics

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

Transcriptomics

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

Metabolomics

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

Microbiomics

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

Bioinformatics

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

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

Bringing a Biopharmaceutical Product to Market

1. Identifying a product
2. Research and Development
3. Clinical trials
4. Manufacturing. Sales and Marketing

Disadvantage to using prokaryotes in the production of biopharmaceuticals

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

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.

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

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

Quality Control (QC)

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

Standard operating Procedure (SOP)

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

Batch Record

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

Assay Validation

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

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

Informed Consent

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

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

patents last for

20 years

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

The Occupational Safety and Health Administration (OSHA)

responsible for regulations pertaining to worker \n safety

The Environmental Protection Agency (EPA)

protection of human health and the environment

The U.S. Department of Agriculture (USDA)

ensures that agriculture and livestock are protected

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

Genetic Information Nondiscrimination Act

prohibits bias that is based on information derived from DNA testing

Pure Food and Drugs Act

prohibited the sale of misbranded or adulterated food and drugs

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

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)

Good Clinical Practice (GCP)

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

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)

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)