antibody and protein therapeutics

Question 1

What is meant by the term “Biologic Therapy”?

Answer 1

Large complex organic products (mostly proteins) synthesized by living cell
• Targeting a gene or protein to modify biologic responses

Question 2

in biological therapy what interactions can be presented

Answer 2

Antibody-antigen interactions
• Cytokine-receptor interactions (both ends)
• Cell signalling proteins, inhibitors, or ligands

Question 3

Which medications have larger complex medicines

Answer 3

Biological mediciations

Question 4

Which medications are normally inorganic

Answer 4

Conventional

Question 5

Are conventional molecules synthesised and purified chemically

Answer 5

Yes

Question 6

Are biological medications encoded genetically transcribed and translated and post translationally modified by living cells

Answer 6

Yes

Question 7

Which structures are easily identifiable and easy to manufacture

Answer 7

Conventional medications

Question 8

What is a biologic

Answer 8

Product of which active ingredient of which is made in a living system

Question 9

What is an bio similar

Answer 9

Biological product approved based on showing its highly similar to an already approved biological product .

Question 10

When can a bio similar be approved

Answer 10

If it has same mechanism of action route of administration dosage form and strength as reference product
Indications and conditions if use that above been previously approved for the reference point

Question 11

What structures of biology’s remain the same

Answer 11

Functional groups

Question 12

What structures of biological change

Answer 12

Tertiary structure

Question 13

Protein based therapeutics advantages

Answer 13

Highly specific complex functions
Developing human protein reduces complications
Allows modification to improve function and pharmacological properties
Less potential for interference and off target effects
Normally well tolerated and low immunogenicity as they’re natural products

Question 14

Whatare group 1 protein therapeutics

Answer 14

Therapeutics with enzymatic or regulatory activity

Question 15

What are group 2 protein therapeutics

Answer 15

Therapeutics with special targeting activity

Question 16

What are group 3 protein therapeutic

Answer 16

Protein vaccines

Question 17

What are group 4 protein therapeutics

Answer 17

Protein diagnostic agents

Question 18

What are the different type within group 1 protein therapeutics

Answer 18

1a replacing a protein which is deficient or abnormal
1b augmenting an existing path
1c providing novel function or activity

Question 19

Within group 2 what different things are there

Answer 19

Interfering with molecule or organism

Delivering other compounds or proteins

Question 20

Within group 3 what are there

Answer 20

Protecting against a deleterious foreign agent
Treating an autoimmune disease
Treating cancer

Question 21

Name a group 1a modification

Answer 21

Insulin

Question 22

Name a group 1b change

Answer 22

Alteplase

Reteplase

Question 23

Name a group 1c change

Answer 23

Botox

Question 24

Name a group 2a modification

Answer 24

Abatacrept

Anakinra

Question 25

Name a group 2b modification

Answer 25

Denileukin diftitox

Question 26

Name a group 3 protein vaccine

Answer 26

Hep B

HPV

Question 27

Name a group 4 protein diagnostic

Answer 27

Glucagon

Question 28

How are nonrecombinat proteins purified

Answer 28

Pancreatic enzymes from pig pancreas
Alpha 1 protease inhibitor from pooled human plasma
Recombinant protein systems

Question 29

What is an antibody

Answer 29

Protein used by the immune system to identify and neutralise foreign objects liek bacteria and viruses

Question 30

What are monoclonal antibodies s

Answer 30

Antibodies identical because they were produced by one type of immune cell, all clones of a single parent cell

Question 31

What are isotopes

Answer 31

According to differences in their heavy chain constant domains, immunoglobulins are grouped into 5 classes.

Question 32

What are murine sources mAbs

Answer 32

Rodent mAbs with excellent affinities and specificity generated using conventional hybridoma technology
Efficacy compromised by human anti murine antibody response- allergic hyper sensitivities

Question 33

Chimeric mABs

Answer 33

Combine human constant regions with intact rodent variable regions. Affinity and specificity unchanged
Also cause human anti chimeric antibody response

Question 34

Humanised mAbs

Answer 34

Contain CDRs of rodent variable region grafted into human variable region framework

Question 35

Name the biological modification used to treat RA with anti tnf therapy

Answer 35

Entanercept

Infliximab

Question 36

B cell depleting agents biological therapy in RA

Answer 36

Rituximab

Question 37

biological therapy for RA: T-cell co stimulation inhibitors

Answer 37

Abatacept

Question 38

Biological therapy for RA: Inhibitors of IL-6 signalling

Answer 38

Tocilizumab (anti Il-6 receptor antibody)

Question 39

biological therapy for RA: IL-1 Inhibitors

Answer 39

Anakinra

Question 40

why would you target TNFa

Answer 40

High concentration of TNFα in
synovial joints of rheumatoid
arthritis patients

TNFα interacts with p55 and p75
TNFα receptor on target cell of
synovial tissue.

Signalling Ca2+ release in cells,
triggers cell apoptosis.