How to check immunogenicity of therapeutic peptides made of unnatural amino acids?
Dear Rituparna Sinha Roy,
Methods and general approach should be more less the same like in case "regular" biologics. High level plan you can find following documents below:
Guideline on Immunogenicity assessment of therapeutic proteins
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-immunogenicity-assessment-therapeutic-proteins-revision-1_en.pdf
Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody Detection
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm629728.pdf
Article Compatibility of immunogenicity guidance by the EMA and the US FDA
I think its key documents, however regardless scope of that document remember that after lysis of peptides, internalization process generating some signaling sequences which interact with MHC. See example of tregitopes. So in case of unnatural amino-acids such short sequences could generate not predictable effects...
New tregitopes inducing adaptive regulatory T cells in mice.
http://www.jpp.krakow.pl/journal/archive/12_17/pdf/897_12_17_article.pdf
Best regards
Tomasz
- Badges
- Science topic
- Similar topics
- Biological Science
- Biochemistry
- Biomolecules
- Peptides