04_Biologics Flashcards
Examples of small molecule drugs and biologic drugs?
Small molecule drugs: ibrutinib & lenalidomide.
Biologic drugs : dulaglutide & pembrolizumab.
How do the molecular weights of small molecules compare to biologics?
Molecular weight of Small molecules inf
Biologics, made of proteins, sup 1,000 g/mol (eg: dulaglutide at 63 kilodaltons & pembrolizumab at 149 kilodaltons)
How does absorption differ between small molecules and biologics?
Small molecules : higher membrane permeability (favor oral A)
Biologics: poor membrane permeability (poor F)
What is the Vd for biologics?
Biologics = poor membrane permeability SO are confined to the plasma and interstitial fluids due to their , resulting in a low volume of distribution.
How are biologics cleared from the body?
Biologics are typically cleared via intracellular lysosomal proteolytic degradation, with minimal hepatic and renal clearance due to their large size.
What is Fc recycling and how does it affect biologics?
Fc recycling is a process that greatly extends the serum half-life of biologics, especially monoclonal antibodies.
Why do biologics have longer half-lives compared to small molecules?
Due to their small clearance, biologics such as pembrolizumab and dulaglutide have very long half-lives, ranging from days to weeks.
What are the risks associated with biologics’ high molecular weight?
Biologics can interact with the immune system, potentially triggering an immune response that can lead to rapid degradation, inactivation, or even anaphylactic reactions.
How is immunogenicity risk managed in biologics development?
Immunogenicity risk is managed by constructing biologics to closely resemble human proteins and monitoring immune responses during pre-clinical and clinical phases.
