Considerations for the genotoxicity assessment of middle size peptide drugs containing non-canonical amino acid residues.
Genes Environ
; 45(1): 36, 2023 Dec 13.
Article
em En
| MEDLINE
| ID: mdl-38093344
ABSTRACT
BACKGROUND:
Middle size peptides (MSPs) have emerged as a promising new pharmaceutical modality. We are seeking the best way to assess the non-clinical safety of MSPs. CONSIDERATION The requirements for assessing the genotoxicity of pharmaceuticals differ between small molecule drugs and biotherapeutics. Genotoxicity tests are necessary for small molecule drugs but not for biotherapeutics. MSPs, however, share similarities with both small molecule drugs and biotherapeutics. Here, we describe important points to consider in assessing the genotoxicity of MSP drugs. The current standard of genotoxicity assessment for small molecules may not be entirely appropriate for MSP drugs. MSP drugs need genotoxicity assessment mostly according to the current standard of small molecule drugs.CONCLUSION:
We propose a few modifications to the standard test battery of genotoxicity tests, specifically, the inclusion of an in vitro gene mutation test using mammalian cells, and exclusion of (Q)SAR assessment on MSP-related impurities.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Idioma:
En
Revista:
Genes Environ
Ano de publicação:
2023
Tipo de documento:
Article
País de afiliação:
Japão