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Stability Testing > Stability of biologies > Flashcards

Stability of biologies Flashcards

1
Q

What are biologies?

A

thoes are pharmaceutical products obtained diretly from living organism.

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2
Q

Examples of biologicals

A

Blood plasma products, vaccines

antivenoms

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3
Q

Why are biologies stored at low temperature?

A

Because there are more labile

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4
Q

is there any difference regarding the climatic zones?

A

For cold or frozen product there is no different

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5
Q

where does the activity of biologies comes from

A

from protein

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6
Q

structures of protein

A

covalently bounded primary structure

folder conformation: secondary and tertiary structure

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7
Q

What happend when there is a change in the conformation?

A

the protein will be in the denatured state, resultsing to loss of biological activity

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8
Q

Common bioassay

A

ELISA and immunblot methods

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9
Q

Method for the distribution of proteins

A

size-exclusion HPLC, SDS-Page

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10
Q

How can protein instabilities be categorized

A

Aggregation, deamidation, denaturation and oxidation

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11
Q

How can the proteine instability be divided

A

Chemical and pysical instabilities

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12
Q

What are chemical instabilities?

A

break or cvalent bonds, resulting in new chemical enthities

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13
Q

it is possibe to clearly discern the different instability (chemical and physical)

A

no, not always possible

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14
Q

Which amino acids preperably undergo oxidation and deamidation reactions?

A

Cysteine, histidine and tyrosine for oxidation

Glutamate

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15
Q

What does deamidation means?

A

Removal of the amino acid and converted to ammonia, which whoes toxic activity

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16
Q

What does physical instability means?

A

Changes its pyhsical state without any change in the chemical composition

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17
Q

Example of pyhsical change

A

Aggregation and precipitation and denaturation

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18
Q

How is the conformational stabiliy achieved?

A

optimization of the structural stability of the protein by maximinzing the gibbs energy

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19
Q

How can the gibbs energies be measured?

A

Differential scanning calorimetry (DSC) and isothermal chemical denaturation (ICD)

20
Q

What causes aggregation in protein ?

A

incorrect folding druing protein expression.

21
Q

what is the most influential factor in modulating aggregation?

A

the conformational stability

22
Q

How are biologics administered?

A

parenterally

23
Q

What are the requirements for parenteral products?

A

Sterile, free from visable particles,

24
Q

How can the conformation stabilization achieved in aquaous solution?

A

By applying sugar or polyol ,this are osmoytes which increases the conformational stability to proteins
Also salts

25
Q

Which sugars should be avoided here?

What know reaction can occur

A

Sugras with protines reactions (lactse, reduced surgers). there will covalently bond to the sugar and so lose of the effcient

26
Q

How can proteins be conformational stabilization?

A

by ligand inding to the native state
by ions
by drying

27
Q

Stabilization by drying?

A

lyophilization

28
Q

Stabilization of proteins by ions?

A

adding of salts to protein solution, specific interactions (binding of cations or anions directly to the protein

29
Q

Stabilization of proteins by ligand binding

A

ligands which bind selectively to the naive state resulsting in net stabilization. excipients (including surfactants

30
Q

what could happend during freezing?

A

cold denaturation could occure, prevention by adding non-ionic surfactants (polysorbate 20 or 80)

31
Q

improvement of protein stability during freezedrying

A

plasticizers (water, glycerol or sorbitol)

buclking agents such as mannitol or glycine

32
Q

what are the relevant ICH guidlines?

A

ICH Q1 A(R2) for general requirements
ICH Q5C guideline for additional consideration
ICH Q6B specification for boilogics
ICH Q5E for biotechological/biological products

33
Q

does the guidlines QC5 cover antibiotics, heparins or vitamine

A

No

34
Q

for what can the ICH Q1 staibility guidlines used for?

A

generally applicable to biologics, good starting place for designing stabiity protocols

35
Q

For how many batches should stability date be provided (drug substance)

A

at least three batches, representative of the manufacturing scale of production

36
Q

stability study of the drug product

A

at least three batches of final container prouct

37
Q

What is a stability-indicating profile?

A

it should assure that change in identity, purity and potency of the product will be detected

38
Q

Purity and molecular characterization method?

A

SDS-page, western blots

39
Q

what are other product characteristics?

A

Viscual appearance, sterility tessting, additivies and container/closure

40
Q

What is a biosimilar?

A

is a biological medicine highly similar to another already approved biological medicine
interms of structure, biological activity and efficacy, saftey and immuogenicity profile

41
Q

What is necessary for the demonstration of bioequivalence

A

that will be for generic products, pharmacological studies

42
Q

Why are BE-study not suitbale for biosimilar?

A

Because of their different pharmacokinetics and stability of the biosilmilar

43
Q

What studies have to be conducted for biosimilar?

A

clinical studies, to check the efficacy, phase 3 studies

44
Q

According to which criteria is the reference product selected?

A

nterms of structure, biological activity and efficacy, saftey and immuogenicity profile

45
Q

aim of conformational studies

A

identiying conditions that maximize the structural stability of the native sate and prevent aggrgation

46
Q

Biologics exist in equilibrium between

A

native, partially denaturated and denaturated conformational states

Stability Testing (5 decks)

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