Week 1

Question 1

What is biotechnology?

Answer 1

Any technological application that uses living organisms or substances from those organisms to make or modify a product

Question 2

What is Industrial biotechnology?

Answer 2

It is the application of biotechnology for industrial purposes

Question 3

What is red biotechnology?

Answer 3

health and medical sector including disease and diagnostics

Question 4

What is green biotechnology?

Answer 4

agriculture, plant and environment

Question 5

What is white biotechnology?

Answer 5

industrial sector

Question 6

What is blue biotechnology?

Answer 6

aquaculture and marine

Question 7

What is gold biotechnology?

Answer 7

bioinformatics and nano-biotechnology

Question 8

What is yellow biotechnology?

Answer 8

food and nutrition

Question 9

What is biochemical engineering?

Answer 9

It is the application of chemical engineering methods and approaches to industrial processes based on biological elements such as living cells

Question 10

What are biopharmaceuticals?

Answer 10

They are drugs that mimic compounds found within the body and are produced using biotechnologies (e.g. medical drugs)

Question 11

What are biosimilars?

Answer 11

Lower-cost, highly similar versions of approved biologic drugs, made by other companies after patent expiry, with no significant differences in safety or effectiveness.

Question 12

What is regenerative medicine?

Answer 12

It is any therapy that aims to induce the regeneration of tissues or organs following disease or injury, or in the presence of birth or developmental deformities

Question 13

What is tissue engineering?

Answer 13

A field combining life sciences and engineering to create functional substitutes that repair or replace damaged tissues or organs.

Question 14

What is ATMPs and what does it stand for?

Answer 14

Advanced Therapy Medicinal Products. They are advanced treatments using gene therapy, cell therapy (autologous or allogeneic), or tissue engineering to treat or cure diseases by repairing, replacing, or modifying cells or genetic material.

Question 15

What does “autologous” mean in medical therapies?

Answer 15

The donor and the patient are the same person (donor = patient).

Question 16

What does “allogeneic” mean in medical therapies?

Answer 16

The donor and the patient are different individuals (donor ≠ patient).

Question 17

Give two examples of autologous therapies.

Answer 17

• Bone marrow transplants (cells collected in remission and used later)
• Skin or bone grafts (plastic/reconstructive surgery using patient’s own tissue)

Question 18

Give examples of allogeneic therapies.

Answer 18

• Bone marrow transplants
• Organ transplants (risk of immune rejection)
• Skin or bone grafts (immune rejection risk)
• Zalmoxis (MolMed) – supports immune reconstruction post-transplant

Question 19

What is a key risk of allogeneic therapies?

Answer 19

Immune rejection and limited availability of donors.

Question 20

Who coined the term “Biotechnology” and when?

Answer 20

Karl Ereky in 1917 — defined it as “converting raw material into a more useful product.”

Question 21

When and where was the first antibiotic discovered?

Answer 21

500 BC in China, from mouldy soybean curds.

Question 22

When was the first insecticide produced?

Answer 22

100 AD in China.

Question 23

Who pioneered vaccination and when?

Answer 23

Edward Jenner in 1761 (smallpox vaccine).

Question 24

When was the first experimental corn hybrid produced?

Answer 24

1870.

Question 25

Who discovered penicillin and when?

Answer 25

Alexander Fleming in 1928.

Question 26

When was penicillin mass-produced?

Answer 26

1942.

Question 27

When was the first synthetic antibiotic created?

Answer 27

1950s.

Question 28

What milestone occurred in livestock biotechnology in 1951?

Answer 28

Artificial insemination using frozen semen.

Question 29

When was DNA first made in a test tube?

Answer 29

1958.

Question 30

When was recombinant human insulin produced?

Answer 30

1978.

Question 31

When was human growth hormone first synthesised?

Answer 31

1979.

Question 32

When did FDA approve human insulin produced in genetically modified bacteria?

Answer 32

1982.

Question 33

What major vaccine approval occurred in 1986?

Answer 33

The first recombinant human vaccine (Hepatitis B).

Question 34

What was the first anticancer drug produced via biotech?

Answer 34

Interferon, in 1986.

Question 35

When and on whom was the first successful gene therapy performed?

Answer 35

1990, on a 4-year-old girl with an immune disorder.

Question 36

What is Betaseron and when was it approved?

Answer 36

A treatment for multiple sclerosis, approved in 1993.

Question 37

What was cloned in 1997 and by whom?

Answer 37

A sheep named Dolly, the first animal cloned from an adult cell (Scotland).

Question 38

When was the Human Genome Project completed?

Answer 38

2003.

Question 39

What was the first vaccine approved for avian flu, and when?

Answer 39

H5N1 vaccine, approved in 2007.

Question 40

What is bioprocessing?

Answer 40

It is a branch of biotechnology and it is the application of natural or genetically manipulated whole cells/tissues/organs etc to produce industrially or medically important products

Question 41

What is the main difference between chemical processing and bioprocessing?

Answer 41

Chemical processing uses chemical reactions in reactors, while bioprocessing uses living cells as bioreactors to produce products.

Question 42

What kinds of products are obtained from bioprocessing?

Answer 42

Cells, small molecules, and enzymes.

Question 43

What do living organisms in bioprocesses require for growth and production?

Answer 43

Specific conditions like temperature, pH, and nutrients.

Question 44

What risk is associated with the culture medium in bioprocessing?

Answer 44

It may support unwanted cell types, leading to contamination.

Question 45

Why are bioproducts difficult to handle in bioprocessing?

Answer 45

They are sensitive to external conditions like temperature and pH.

Question 46

Why is separation important in bioprocesses?

Answer 46

Because the product is usually very diluted and mixed with byproducts (metabolites).

Question 47

What is a key issue with byproducts in bioprocessing?

Answer 47

Metabolites are produced and need to be removed from the medium.

Question 48

What kind of reactions can cells perform in bioprocessing?

Answer 48

Difficult or complex biochemical reactions.

Question 49

What can cells convert in bioprocessing?

Answer 49

Basic nutrients into valuable products.

Question 50

What is one of the most notable benefits of using cells in bioprocesses?

Answer 50

Amazing diversity of products (e.g., proteins, enzymes, drugs).

Question 51

How can cells be altered to improve bioprocessing?

Answer 51

They can be genetically modified to increase product diversity.

Question 52

What role do enzymes play in bioprocessing?

Answer 52

They act as specific catalysts with high catalytic power.

Question 53

What is traditional bioprocessing?

Answer 53

A method that uses cell cultures to produce products — the cell acts as a factory.

Question 54

Give examples of products from traditional bioprocessing.

Answer 54

- Ethanol - Antibiotics - Vaccines / viruses - Recombinant therapeutic proteins (e.g., monoclonal antibodies)

Question 55

What is stem cell bioprocessing?

Answer 55

A type of bioprocessing where the cells themselves are the final product.

Question 56

What are key applications of stem cell bioprocessing?

Answer 56

- Banking and drug screening programs - Stem cell therapies (potential to cure diseases, not just treat symptoms)

Question 57

How does stem cell bioprocessing differ from traditional bioprocessing?

Answer 57

In traditional bioprocessing, cells produce a product; in stem cell bioprocessing, the cells are the product.

Question 58

What is the first step in a general bioprocess?

Answer 58

A single cryovial of cells is taken from the working cell bank (WCB).

Question 59

What are the main stages of upstream processing?

Answer 59

- Media preparation - Cell thawing and inoculum expansion - Bioreactor scale-up (from 50L to 20,000L)

Question 60

What occurs during downstream processing?

Answer 60

Product separation, purification, characterisation, and formulation.

Question 61

What is the role of quality control (QC) in bioprocessing?

Answer 61

To ensure product purity, yield, and consistency at various stages.

Question 62

What are unit operations in bioprocessing?

Answer 62

Steps that change or separate components during the process.

Question 63

Name five examples of unit operations in bioprocessing.

Answer 63

- Centrifugation - Chromatography - Filtration - Evaporation - Distillation

Question 64

Why are unit operations repeated in bioprocesses?

Answer 64

To achieve consistent separation, purification, or transformation.

Question 65

What are the first steps in bioprocess development?

Answer 65

Engineer or isolate the cells and optimise growth/production conditions.

Question 66

What are the key focuses during process development?

Answer 66

- Expanding the cells - Developing purification protocols - Formulation strategies

Question 67

What concept ensures quality at every step in bioprocessing?

Answer 67

Quality by Design (QbD) — integrates product, process, and performance design.

Question 68

What 3 criteria must a biotherapeutic meet to be successful?

Answer 68

1. Clinically effective 2. Approvable by regulatory authorities 3. Commercially viable

Question 69

Give 3 examples of biotherapeutic technologies.

Answer 69

1. Recombinant protein technologies (e.g., monoclonal antibodies) 2. Cell and gene therapies 3. Viral vaccines

Question 70

What are the 5 main steps in the production of recombinant proteins?

Answer 70

1. Genetic engineering of selected cell 2. Expansion into a cell line 3. Cell culture to produce protein 4. Separation of protein from cells 5. Purification of the protein

Question 71

List the 5 key steps in manufacturing cell therapies.

Answer 71

1. Tissue collection (e.g. bone marrow) 2. Cell isolation 3. Expansion of primary cells 4. Cell harvesting 5. Formulation for implantation

Question 72

Outline the steps in viral vaccine manufacturing.

Answer 72

1. Select cell line (e.g. Vero, MDCK) 2. Expand cell line 3. Inoculate with virus 4. Virus inactivation 5. Purify viral particles 6. Produce vaccine particles

Question 73

Why does quality matter in bioprocessing?

Answer 73

Because poor-quality products can harm or kill consumers, and regulatory compliance is essential (e.g., FDA GMP standards).

Question 74

What are the 3 departments that ensure quality in biotech manufacturing?

Answer 74

1. Quality Control (QC) 2. Quality Assurance (QA) 3. Validation

Question 75

What are key components of a Standard Operating Procedure (SOP)?

Answer 75

- Effective date, purpose, scope, responsibility - References, materials/equipment - Procedures, approval signatures