protein therapeutics

Question 1

what is protein therapeutic

Answer 1

are class of medication whose active components are derived from the biological sources by being produced from either microorganism and cells using biotechnology.

Question 2

what is biosimilar drugs

Answer 2

are drugs that are similar to another biological medicine already marked in the EU.

Question 3

what is biosimilar in biological drug including protein therapeutics

Answer 3

is equivalent to generic product in small molecules drugs.

Question 4

what are the technical classification of protein therapeutics

Answer 4

• first generation: are original, not modified protein. ex: human insulin for diabetes
• second generation: are engineered protein either altered in AA sequence or purification. ex: human insulin for diabetes with changed AA sequences

Question 5

what are the functional classification of protein therapeutics

Answer 5

according to leader et al there is 4 groups are defined based on their functionality:
- I : enzymatic activities
- II: targeting/ binding activities
- III: protein vaccines
- IV: protein diagnostics

Question 6

what are the classification function of protein therapeutic based on their group

Answer 6

• group I: replacing deficient or abnormal protein, strengthening existing pathways, novel function.

-group II: interfering with molecule either for targeting for destruction or blocking for binding, selective delivery of small molecules.

• group III: protective against foreigner organism, therapeutic for autoimmune diseases and cancer.
• group IV: in vivo infectious diseases diagnostics, stimulatory.

Question 7

what are protein therapeutics challenges

Answer 7

• size: protein are 1000x larger than small molecules, stability and delivery, different microorganism have to be considered due to different genome size, and proteins can’t be chemically synthesized.
• structure: sequencing foe structural modification is hard to predict, successful production and folding has to be monitored.
• microheterogeneity: small imperfection in protein structure due to process condition or producing cells can lead to instability.
• stability: protein are unstable due to temperature, storage, pH and oxygen.
• immunogenicity: the development of anti-drug-antibody (ADAs) which lead to reduction of drug efficacy.

Question 8

protein therapeutics manufacturing

Question 9

what are the elements of production- process

Answer 9

• upstream : everything until you have protein includes origin, media parameters, host system, and cultivation mode.
• downstream: therapeutic product, this include harvest, purification, more purification and formulation.

Question 10

what parameter to consider during those processes

Answer 10

upstream
-origin; non-recombinant and recombinant
-host: prokaryotic or eukaryotic
- media parameter and scale up: the aim is to produce large scale at a time
- cultivation: homogeneity of culture and heat exchange has to be controlled