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Medicine Pharmaceutics > Biologics > Flashcards

Biologics Flashcards

1
Q

biologics treat mainly?

A

long term diseases
cancer
arthritis
diabetes

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2
Q

why are biologics harder to manufacture than small molecules?

A

their complexity and size

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3
Q

___% of the drug market is biologicals

A

37

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4
Q

TF: biologicals are faster to get onto the market?

why?

A

true

due to the way they’re produced and tested

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5
Q

what is the main reasons for small drug failure?

A

‘one drug suits all’ methodology

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6
Q

what can biologics do to diseased tissue functionality?

A

replace

protein hormones and blood factors

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7
Q

biologics vs small molecule versatility?

A

replace diseased tissue as well as modify it

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8
Q

biologics are highly ______

therefore?

A

specific

therefore, no unspecific binding to molecular structures

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9
Q

half life of biologics are usually?

A

2-3 weeks

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10
Q

what region of mAbs are modified?

A

CDR region

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11
Q

biologics vs small molecules. immunogenic effects are worse for? why?

A

biologics

as the immune system can detect it easier than small molecules

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12
Q

what are ADCs?

A

antibody drug conjugates

a mAbs where there’s cytotoxic drug attached

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13
Q

what are ADCs usually used for?

A

cancer

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14
Q

what can lipid nanoparticles be used for?

A

. Instead of producing the antibody and injecting to patient. You carry the mRNA to produce the protein inside the cell and it gets expressed. These are quite complex. Thought they will be used for very specific diseases.

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15
Q

explain the process of producing monoclonal antibodies (mAbs). UPPER BIOPROCESSES

A

UPPER BIOPROCESSES
immunisation- injected with antigen

Abs are isolated for in vitro hybridoma production

myeloma cells are immobilised cells which are fused with spleen cells= hybridoma capable of unlimited growth

fusion: myeloma cells and isolated splenocytes are fused in the presence of PEG- attracts water causing cell membranes to break and fuse

scale up and wean: scale up clone and wean off the selection agents

expand the clones to produce the desired antibody- using bio reactors

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16
Q

what are used to expand the clones to produce the desired antibody?

A

bioreactors

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17
Q

what is used to fuse myeloma cells and spleen cells? how?

A

PEG
Attracts water molecules causing cell membranes to break
forms hybridoma

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18
Q

what happens after the upper bioprocesses?

A

downstream processes where you mass produce the antibody

19
Q

why are the mAbs produced in batches?

A

they have a life span

have cycles which breaks continuous production- people want to change this

20
Q

what was an issue with using mouse to create human hybridomas?

A

immunogenic reactions and rapid clearance

21
Q

why was there rapid clearance when using mice to create human hybridomas?

A

lack of Fc effector

not recycled as Fc doesn’t bind

22
Q

how long was mice used to create human hybridomas?

A

11 years

23
Q

after using mice what has started to be used more. what does this result in?

A

recombinant engineering

  1. chimeric
  2. humanised
  3. fully humanised
24
Q

what are chimeric?

A

mouse variable region

25
Q

what are humanised?

A

mouse antigen binding loops (CDRs)

26
Q

mAbs therapeutic functions?

A

complement dependent cytotoxicity
Antibody dependent cell medicated cytotoxicity
conjugates
apoptosis induction

27
Q

explain CDC (complement dependent cytotoxicity) have a therapeutic effect

A

antibody will bind to the surface and complement molecules attached- cytotoxicity

28
Q

explain how conjugates have a therapeutic effect

A

antibody attaches to antigen

can have toxins attached

29
Q

explain how apoptosis induction works?

A

Receptor blockages- ligand therefore cannot bind to receptor, this lack of binding means nothing can penetrate or be produced

30
Q

explain how Antibody dependent cell medicated cytotoxicity works?

A

the antibody binds to the antigen on surface, using the fc receptor you get a neutrophil that attaches to the antibody and induces cytotoxicity

31
Q

what does the glycol receptor on mAbs contribute too?

A

glycol mediated clearance and tissue distribution

32
Q

what is the Fc region made from?

how does this give a long half life

A

ch2 and ch3 fragments

IgG recycling for long half life

33
Q

the fab region has lots of _____

A

charges

34
Q

what is the fab region effected by? what’s it made up of

A

charge or isoelectric point

Vh and Vr

35
Q

how are biologics usually administered?

A

sc or im injections

at high concentrations

36
Q

absorption of biologics from sc administration?

A

20-95%- facilitated by the

37
Q

what is sc absorption facilitated by?

A

the lymphatic system

38
Q

sc/ IM rate of absorption?

A

slow

39
Q

sc/ IM maximal plasma concentration after how long

A

1-8 days

40
Q

how are biologics eliminated?

A

proteolytic catabolism by lysosomal degradation

target mediated clearance
Fc gamma receptor

41
Q

how does target mediated elimination pathways work?

A

involves interaction between a mAb and its pharmacological target, and represents the primary route of antibody clearance- binds when it reaches target and then is cleared by the reticulo-endothelial system. The resulting immune complexes are then cleared from the body through reticulo-endothelial system (RES).

42
Q

how does proteolytic catabolism by lysosomal degradation work?

A

your antibody enters the cells, cannot evade the endosome. Amino acids are absorbed into the cells for recycling

43
Q

what is pharmacodynamics

A

effects of drug on the body

44
Q

why are PK/ PD relationships of mAbs unique?

A

as the pharmacokinetics are markedly influenced by the biology of the target antigen

Medicine Pharmaceutics (6 decks)

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