What is Biotechnology


Dec 5, 2012 (5 years and 7 months ago)


Chapter 1

What is Biotechnology

Defining Biotechnology

Biotechnology in one form or another has flourished
since prehistoric times.

Planting their own crops and breed their own animals, they
learned to use biotechnology.

The discovery that fruit juices fermented into wine, or that
milk could be converted into cheese or yogurt, or that beer
could be made by fermenting solutions of malt and hops
began the study of biotechnology.

When the first bakers found that they could make a soft,
spongy bread rather than a firm, thin cracker, they were
acting as fledgling biotechnologists.

The first animal breeders, realizing that different physical
traits could be either magnified or lost by mating appropriate
pairs of animals, engaged in the manipulations of

Defining Biotechnology

“Biotechnology" refers to the use of living organisms or their
products to modify human health and the human environment.

Not just for manipulating whole organisms

Using the techniques of gene splicing and recombinant DNA technology we
can now actually combine the genetic elements of two or more living cells.

Functioning lengths of DNA can be taken from one organism and placed into
the cells of another organism.

We can cause bacterial cells to produce human molecules.

Cows can produce more milk for the same amount of feed.

And we can synthesize therapeutic molecules that have never before existed.

In other words, Biotechnology is the study/manipulation of
living things or the their component molecules, cells, tissues,

Defining Biotechnology

Very expansive field

mostly involves work with

rDNA technology

Cutting/recombining DNA

Polymerase chain reaction

Copying short pieces of DNA

Making large amount of copies


Identical organisms

Essentially many practices from over time

Selective breeding of animals and plants

Defining Biotechnology

Enables production of previously unavailable



Removes stains from clothing


.: not just a science, but an industry, also


Workers and Workplaces

Many settings

Companies, universities, government agencies


Development/manufacture of products for sale

Pharmaceutical, agricultural, industrial products,
industrial. research instruments

Universities/government labs

Mostly “pure” research


Workers and Workplaces

Biotechnology companies


Produce wide variety of products

Goal is produce and sell commercial products “for

Profits go to support internal R & D

Different types of biotech companies

Pharmaceutical products

Agricultural products

Industrial products

Research or production instruments, reagents, or data

Others sell their services

DNA/protein sequencing


Workers and Workplaces

University and Government Research labs

Usually for “pure research”

Not for profit

Uses same techniques as in industry

Doesn’t provide earnings

Support from grants

From industry, foundation, or the government

Data collected

Shared at scientific meetings

Scientific journals

For the public good

Information usually used to further “for
profit” work in industry

Growth in the
Biotechnology Industry

Where are most of the jobs?

Medical instruments and diagnostic tools


Industrial/environmental applications

New agricultural crops


Very dramatic

Original companies found

Bay area



North Carolina

Now can be found anywhere

The Increasing Variety of
Biotechnology Products

Number of products increases every year


Most are natural products

Significant impact on life

Reduced death and suffering

Penicillin form
Penicillium sp

Modifications of the penicillin molecule

Different versions

Used for mutated versions of the bacteria



Plant extracts

Many medical/industrial products

helped fuel industrialization



Maple syrup

Domains of Biotechnology

Industrial and Environmental Biotechnology

Fermented foods and beverages

Genetically engineered proteins for industry

DNA identification/fingerprinting of endangered



Biosensors, bioterrorism, and biodefense


Domains of Biotechnology

Diagnostic Research Biotechnology

DNA and protein synthesis

DNA an protein sequencing, genomics, proteonomics

Genetic testing and screening

DNA identification and DNA fingerprinting, forensics

Bioinformatics and microarrays

Polymerase chain reaction

ELISA, Western Blots, protein identification, purification


Domains of Biotechnology

Medical/Pharmaceutical Biotechnology

Medicines from plants, animals, fungi

Medicines from genetically engineered cells

Monoclonal and polyclonal antibodies

Vaccine and gene therapy

Prosthetics, artificial or engineered organs and

Designer drugs and antibodies

Domains of Biotechnology

Agricultural Biotechnology

Breeding of livestock and plant crops

Aquaculture and marine biotechnology

Horticultural products

Asexual plant propagation and plant tissue culture

Transgenic plants and animals

Production of plant fibers

Pharmaceuticals in genetically engineered plant

Bioengineered Products

A Snowballing Effect
began with structure of


Restriction enzymes

Cut DNA a very particular places in the sequence

DNA ligase

Anneals DNA
pastes the pieces together

Creates new combinations

Called recombinant DNA

Inserted into cells to give new characteristics

Called bioengineered or Genetically Modified Organisms

Bioengineered Products

First GMOs

Human growth hormone Somatostatin

Human gene into
E. coli


Human tissue plasminogen activator (t

True bioengineered product

Blood clot dissolving enzyme

Clears blocked blood vessels after heart attack or stoke

Only produced in very small amounts by the human body

Now produced by engineered CHO cells (pg 12; figure

How Companies Select Products to

Companies usually specialize in a group of
similar products

Bayer Biotech

Therapeutic drugs


Plant products


Similar products produced in similar ways

Reduces manufacturing costs

Reduces supply costs

How Companies Select Products to

R & D

Goal is to market product ASAP

R & D can take years

Proof of concept needed from the research laboratory

Then move into development phase

Several things assessed

Is it feasible to produce a new medicine in amounts needed to treat

What to do to ensure safety

How do you prove efficacy (effective)


If the assessment is favorable, then moves to clinical development

First small scale production

Then large
scale production


Guided by the FDA

Takes about 10
15 years to go through the “pipeline”

R & D
Product Development Plan

Product Planning is critical to any organization

A well
conceived and comprehensive Product Development Plan (PDP) can
provide a detailed assessment of your product and the most effective
pathway to market or licensure.

The PDP is:

A "roadmap" for your product's development

A concise, product
focused strategic document laying out the path to market
approval or licensure

A detailed analysis of your product status and developmental requirements

Includes four primary aspects of product development



Regulatory Development

Clinical Development

An integrated stand
alone document tying all the four main areas of product
development with budgets, tasks and timelines through Phase 1 or beyond

R & D
Product Development Plan

Why Develop a PDP?

Planning is crucial at every stage of development,
particularly at the outset

Provides a concise detailed analysis of your product and the
roadmap to market

Clearly states developmental objectives and crucial

Presents a single (or multiple, if desired) focused regulatory
strategy for presenting your product to the FDA

Presents strategies for dealing with potential roadblocks
and hurdles in the product development process

Lays out accurate and realistic budgets and timelines
through clinical development

Regulations Governing Product

All biotech products heavily regulated


Drugs and cosmetics



See page 18, figure 1.24

Scientific Methodology in a Research

To ensure unbiased, reproducible data

Usually occurs in 5 general steps of asking and
answering scientific questions

1. State a testable scientific question/problem based on
some information or observation

Usually comes from previous experimental results or a new

2. Develop a testable hypothesis

A statement that attempts to answer the scientific question

Implies how to test and the kind of data to be collected

Scientific Methodology in a Research

3. Plan a valid experiment

Contains quantitative data, multiple replications, a SINGLE
manipulated variable, and a control


2 types

Positive control
gives predictable results

Negative control

lacks what is being tested so as to give
expected negative results

4. Conduct the outlined experiment and collect and
organize the data into tables, charts, graphs, or graphics

5. Formulate a conclusion based on experimental data and
error analysis

conclusion also suggests further experimentation and
applications of the findings