1.
Nucleic Acid Ther
; 27(6): 309-322, 2017 Dec.
Artigo
em Inglês
| MEDLINE
| ID: mdl-29125795
RESUMO
This white paper, which is the 10th in a series intended to address issues associated with the development of therapeutic oligonucleotides, examines the subject of product-related impurities. The authors consider chemistry and safety aspects and advance arguments in favor of platform approaches to impurity identification and qualification. Reporting, identification, and qualification thresholds suitable for product-related impurities of therapeutic oligonucleotides are proposed.