Biopharmaceutical products and vaccines

Question 1

Biotechnology uses _________ to create products or processes that ____________________

Answer 1

living organisms
help improve the quality of life for humans or other organisms.

Question 2

Is a science dating back to ancient civilizations when microbes were used to make products like wine and beer, vinegar, breads, and cheeses.

Answer 2

Biotechnology

Question 3

Modern Biotech began shortly after

Answer 3

recombinant DNA technology was developed.

Question 4

Genetic engineering, Genetic modification is the ability to

Answer 4

manipulate DNA in vitro and to introduce genes into living cells has allowed scientists to generate new varieties of plants, animals, and other organisms with specific traits.

Question 5

Genetic engineering typically involves the use of

Answer 5

recombinant DNA technologies

Question 6

Genetic engineering typically involves the use of recombinant DNA technologies to

Answer 6

add a gene or genes to a genome, but it can also involve gene removal.

Question 7

(GMOs).

Answer 7

genetically modified organisms

Question 8

Genome editing

Answer 8

can potentially edit DNA in vivo to introduce specific mutations in a very precise manner, without introducing additional DNA into the recipient organism.

Question 9

An example of a GMO

Answer 9

E. coli in colonies, have been genetically engineered to produce lycopene – an antioxidant found in abundance in tomatoe, giving them their characteristic red-color

Question 10

Biopharming produces valuable proteins in genetically modified (GM) animals and plants. GMOs are used extensively in the pharmaceutical industry for the production of a variety of products, especially

Answer 10

therapeutic proteins to treat diseases.

Question 11

Prior to recombinant DNA, biopharmaceuticals such as insulin, were purified from

Answer 11

the pancreas.

Question 12

The first commercial biotech product, manufactured by recombinant DNA technology, was human insulin, called

Answer 12

Humulin®, was licensed for therapeutic use in 1982.

Question 13

Previously, insulin was chemically extracted from the pancreas of

Answer 13

cows and pigs at abattoirs.

Question 14

Shortly after insulin, the __________________ was cloned, and turned into a commercial product to treat children who suffer from a form of dwarfism.

Answer 14

human growth hormone gene

Question 15

Many therapeutic proteins have since been produced by expressing human genes in bacteria.

Question 16

In most cases, the human gene is cloned into a ______, and the _________ is introduced into the bacterial host, which are grown in large industrial fermenters, and the recombinant human proteins are _________ from these bacterial cultures.

Answer 16

plasmid
recombinant vector
recovered and purified

Question 17

Bacterial expression systems often fail to properly process the ___________________ required for eukaryotic proteins to be fully functional.

Answer 17

post-translational modifications (like glycosylation or phosphorylation)

Question 18

In addition, eukaryotic proteins produced in bacterial cells often do not ______________________ required for functionality.

Answer 18

fold into the proper three-dimensional conformation

Question 19

Other expression hosts include yeast and even insect cell lines.

Answer 19

They are able to overcome differences observed between expressing human proteins in pro- vs. eukaryotic systems.

Question 20

Transgenic animal systems can solve these problems

Answer 20

– examples are yeast cells, insect cell lines, or transgenic animals, which can act as living ‘bioreactors’ or ‘biofactories’.

Question 21

In 2006, antithrombin (anticlotting protein in blood)

Answer 21

became the first drug to be produced in the milk of farm animals, after the human antithrombin gene was expressed in the mammary glands of goats.

Question 22

In one year, a single goat will produce the equivalent amount of antithrombin that would require

Answer 22

∼90,000 human blood collections.

Question 23

Chickens are easier to rear and more efficient as biofactories

Answer 23

– very efficient in glycosylating recombinant proteins.

Question 24

Kanuma is made from _____________ expressing a recombinant form of the enzyme ______________________, that is used as a medication for the treatment of __________________.

Answer 24

the eggs of GM chickens
lysosomal acid lipase (LAL), or sebelipase alfa
lysosomal acid lipase deficiency

Question 25

Question 26

2 types of vaccines:

Answer 26

Inactivated vaccines and attenuated vaccines

Question 27

Inactivated vaccines

Answer 27

are prepared from ‘killed’ versions of the infectious virus or bacteria,
e.g. Rabies and Influenza

Question 28

Attenuated vaccines

Answer 28

are ‘live’ viruses or bacteria that can no longer reproduce but can cause a mild form of the disease,
e.g. Tuberculosis, cholera, and chickenpox.

Question 29

Genetic engineering is being used to produce subunit vaccines, which consist of

Answer 29

one or more antigenic surface proteins from the virus or bacterium rather than the entire virus or bacterium, e.g. Johnson&Johnson SARS-Cov-2 vaccine.

Question 30

In subunit vaccines the surface protein acts as

Answer 30

an antigen that stimulates the immune system to make antibodies that act against the organism from which it was derived.

Question 31

In 2005,

Answer 31

the FDA approved Gardasil®, a subunit vaccine that targets four strains of human papillomavirus (HPV) that cause cervical cancers.

Question 32

In 2014,

Answer 32

the National Department of Health introduced HPV vaccination as a central strategy for cervical cancer prevention in South Africa. Cervical cancer is the 2nd most common cancer among South African women.

Question 33

Plants offer several advantages for

Answer 33

expressing recombinant proteins.

Question 34

Advantages of vaccine production in plants

Answer 34

1. Once a transgenic plant is created, it can easily be grown and vegetatively propagated in a greenhouse or field to provide a constant source of recombinant protein.
2. The cost of expressing a recombinant protein in a transgenic plant is much lower than making the same protein in bacteria, yeast, or mammalian cells.

Question 35

disadvantages of vaccine production in plants

Answer 35

temperature sensitivity and sterile conditions for administering.

Question 36

Antibodies against Ebolavirus were expressed in tobacco leaves.

Answer 36

Ebola monoclonal antibody genes from transgenic mice were introduced into tobacco plants, which expressed high quantities of the antibody proteins. These can be isolated and purified for use in humans.

Question 37

A vaccine against a bacterium that causes cholera has been produced

Answer 37

in genetically engineered potatoes and used to successfully vaccinate human volunteers.

Question 38

DNA-based vaccines relies on the fact that

Answer 38

inserted recombinant DNA would express pathogen-specific proteins, which would trigger an immune response.

Question 39

How do DNA-based vaccines work?

Answer 39

DNA encoding proteins from a particular pathogen are inserted into plasmid vectors, which are then injected directly into an individual or delivered via a viral vector similar to the way certain viruses are used for gene therapy.

Question 40

Example of DNA vaccine:

Answer 40

Trials with DNA expressing the pre-membrane and envelope proteins of Zikavirus (ZIKV – causes microcephaly) created high levels of antibodies in mice and Rhesus monkeys and was capable of neutralizing ZIKV and protecting against ZIKV infection – now in human clinical trials.

Question 41

mRNA vaccines

Answer 41

an mRNA is stabilised and injected, will be translated into an antigenic protein that will stimulate the immune system to produce antibodies, e.g. the Pfizer SARS-Cov-2 vaccine.