Group 6 Presentation Flashcards
What are traditional biologics?
Blood products, human cells and animal cells
What are modern biologics
Biotechnology-derived therapeutics
- Recombinant therapeutic proteins such as monoclonal antibodies, cytokines, Fc proteins and peptides; gene therapy and cellular products
What happens after biologics is metabolized into small peptide fragements?
Either go through renal excretion or are recycled into protein synthesis
Rate of metabolism is?
compound/modality dependent
Metabolism of low MWs?
Very rapid
- Stability can be assessed in vitro
Metabolism of human IgG
Very slow
When describing pharmacokinetics you must?
Address a specific class to describe
ADME issues are different for?
Therapeutic biologics due to larger size and more complicated structure
Challenges of ADME studies?
Lack effectiveness and validation in vitro systems
- No reliable system to predict bioavailability after administration
What are species dependent?
Target mediated clearance and antidrug-antibody mediated clearance –> make it hard to tell how it will act in a human
Generic ELISA recognizes what?
Fc protion of human protein and can help to support studies in animals
Mass spectrometry?
Used for bio-analysis
- Improved selectivity between structurally similar proteins, less requirements for reagents and improve precision and accuracy
Common techniques for bio-distribution studies?
Opitcal immaging with luminescence and fluorescence molecular probes
Radiotracer- SPECT
PET
MRI, ultra sound and x-rays
What are ADCs?
Complex drugs that consist of potent cytotoxic drugs linked to antibodies
Potential to produce tumor specific delivery of drugs
Improved safety when compared to monodrug
Longer half life because of the antibody portion
