Considerations for the genotoxicity assessment of middle size peptide drugs containing non-canonical amino acid residues
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Matsumoto Y, Sawamura J, Murata Y, Nishikata T, Yazaki R, Ohshima T. Amino Acid Schiff Base Bearing Benzophenone Imine As a Platform for Highly Congested Unnatural α-Amino Acid Synthesis. J Am Chem Soc. 2020;142(18):8498–505.
Wang W, Khojasteh SC, Su D. Biosynthetic strategies for macrocyclic peptides. Molecules. 2021;26(11):3338.
Inokuma T. Synthesis of Non-canonical Amino Acids and Peptide Containing Them for Establishment of the Template for Drug Discovery. Chem Pharm Bull (Tokyo). 2021;69(4):303–13.
Fuse S, Otake Y, Nakamura H. Peptide Synthesis Utilizing Micro-flow Technology. Chem Asiam J. 2018;13(24):3818–32.
Du Y, Li L, Zheng Y, Liu J, Gong J, Qiu Z, et al. Incorporation of Non-Canonical Amino Acids into Antimicrobial Peptides: Advances, Challenges, and Perspectives. Appl Environ Microbiol. 2022;88(23):e0161722.
Sakai K, Sugano-Nakamura N, Mihara E, Rojas-Chaverra NM, Watanabe S, Sato H, et al. Designing receptor agonists with enhanced pharmacokinetics by grafting macrocyclic peptides into fragment crystallizable regions. Nat Biomed Eng. 2023;7(2):164–76.
Mishiro K, Ueno T, Wakabayashi H, Fukui M, Kinuya S, Ogawa K. Synthesis and evaluation of a deltic guanidinium analogue of a cyclic RGD peptide. Org Biomol Chem. 2023;21(9):1937–41.
Kobayashi M, Fujita K, Matsuda K, Wakimoto T. Streamlined Chemoenzymatic Synthesis of Cyclic Peptides by Non-ribosomal Peptide Cyclases. J Am Chem Soc. 2023;145(6):3270–5.
Takayama K, Hitachi K, Okamoto H, Saitoh M, Odagiri M, Ohfusa R, Shimada T, Taguchi A, Taniguchi A, Tsuchida K, Hayashi Y. Development of Myostatin Inhibitory d-Peptides to Enhance the Potency, Increasing Skeletal Muscle Mass in Mice. ACS Med Chem Lett. 2022;13(3):492–8.
Stebbings R, Poole S, Thorpe R. Safety of biologics, lessons learnt from TGN1412. Curr Opin Biotechnol. 2009;20(6):673–7.
S6(R1) I. Preclinical safety evaluation of biotechnology-derived pharmaceuticals. 2011.
Liu J, Farmer JD Jr, Lane WS, Friedman J, Weissman I, Schreiber SL. Calcineurin is a common target of cyclophilin-cyclosporin A and FKBP-FK506 complexes. Cell. 1991;66(4):807–15.
Takeuchi K, Misaki I, Tokunaga Y, Fujisaki M, Kamoshida H, Takizawa T, et al. Conformational Plasticity of Cyclic Ras-Inhibitor Peptides Defines Cell Permeabilization Activity. Angew Chem Int Ed Engl. 2021;60(12):6567–72.
Zhang Q, Liu N, Wang J, Liu Y, Wang K, Zhang J, et al. The recent advance of cell-penetrating and tumor-targeting peptides as drug delivery systems based on tumor microenvironment. Mol Pharm. 2023;20(2):789–809.
S2(R1) I. Guidance on genotoxicity testing and data interoretation for pharmaceuticals intended for human use. 2011.
Prajapati JD, Kleinekathöfer U, Winterhalter M. How to Enter a Bacterium: Bacterial Porins and the Permeation of Antibiotics. Chem Rev. 2021;121(9):5158–92.
Maron DM, Ames BN. Revised methods for the Salmonella mutagenicity test. Mutat Res. 1983;113(3–4):173–215.
Roantree RJ, Kuo TT, MacPhee DG. The effect of defined lipopolysaccharide core defects upon antibiotic resistances of Salmonella typhimurium. J Gen Microbiol. 1977;103(2):223–34.
Doerr CL, Harrington-Brock K, Moore MM. Micronucleus, chromosome aberration, and small-colony TK mutant analysis to quantitate chromosomal damage in L5178Y mouse lymphoma cells. Mutat Res. 1989;222(3):191–203.
Umezawa K, Haresaku M, Muramatsu M, Matsushima T. Mutagenicity of anthracycline glycosides and bleomycins in Salmonella assay system. Biomed Pharmacother. 1987;41(5):214–8.
M7(R2) I. Assessment and control of DNA reactive (mutagenic) impurities in phermaceuticals to limit potential carcinogenic risk. 2023.