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Large Molecule PK

Large Molecule PK - Final Info

QuestionAnswer
Name 2 areas where therapeutic proteins (ie. monoclonal Ig) are playing an increasing role? Oncology & immune-mediated diseases
Therapeutic proteins have potential for ________________ in any PK process (ADME). Nonlinearities
Why is mathematical moeling for therapeutic protein PK data necessary? Required to characterize complex nonlinear PK properties
How is FcRn (neonate Fc receptor) useful? It can salvage endogenous IgG or IgG-based monoclonal Ig's from degradation
How long is the half-life for most human/humanized monoclonal Ig's?What implications does this have for dosing? T1/2 ~2-3 weeks - allows for LESS FREQUENT DOSING (ie. q8-12weeks)!
What PK parameter is affected by the degree of "human-ness" & how so? T1/2. Increase T1/2 with increasing degree of "human-ness" ** T1/2 HIGHEST --> lowest: humanized > chimeric > murine
Comparability for therapeutic proteins depends on a combination of what 3 factors? - Biochemical, biological, & PK comparabilities
What immune/physiologic reaction is likely to occur upon administration of a protein 'antigen'? Antibody formation due to to its "foreign" nature
Name 2 outcomes that may occur if an unwanted immune response (immunogenicity) does occur? Loss of efficacy and/or severe SE (woof!)
Contrast metabolism between small & large molecules. -Small: generally by CYP450 and/or renally excreted *Large: elim by specific & non-specific pathways - Non-specific ex: FcRn-med recycling, proteolysis, Fc(g)R-intxn - Specific ex: TMDD (target-med-drug disposition) pathway
By what mechanism could certain disease states cause a possible drug-disease interaction with a large molecule? Pro-Inflammatory diseases (inflam, infection, RA) can cause higher CYTOKINE levels (ie. IL-6, TNF-a, INF-(g), IL-1(b)) --> DOWN REGULATION of CYP450 enz involved in metabolism
What could be used to resolve a drug-disease interaction with a large molecule? Therapeutic proteins (ie. mAbs) that target certain cytokines (ie. IL-6) can REVERSE the cytokine-induced CYP450 depression!
What is the predicted % of large molecule medicines that will be approved within the next couple of years? > 50%!
Brand:Generic as Biological meds:_________________ (term) Bio-similar
Name a HUGE advantage (esp for patients) of bio-similar production COST! Currently, most pt's cannot afford due to such a high cost. Bio-similars can be produced at a considerably lower cost allowing MARKET EXPANSION & LOWER HEALTHCARE COSTS
The general consensus among analysts attribute ____% cost reduction due to bio-similars (vs. innovator products) 25-35% - so pretty darn significant!
Name 4 intrinsic factors that affect therapeutic protein CL. - Affinity to FcRn - Anti-Drug Antibody formation - Proteolytic degradation - Receptor binding & internalization
Created by: myassen
 

 



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