RESUMEN
The designation of starting materials (SMs) for pharmaceuticals has been a topic of great interest and debate since the first ICH quality guidance was published. The increase in the number and variety of commercialized oligonucleotides (antisense oligonucleotides-ASOs, small interfering RNAs-siRNAs, etc.) in recent years has reignited dialogue on this topic because of the unique complexity of the monomeric nucleotides and other contributory materials used to manufacture oligonucleotides. The SM working group in the European Pharma Oligonucleotide Consortium (EPOC) was formed to help establish simple, risk-based criteria to guide the justification of oligonucleotide SMs. This article provides a description of the common types of SMs, classes of SM impurities, and control strategies that will be helpful to maintain manufacturing consistency.
Asunto(s)
Industria Farmacéutica/tendencias , Enfermedades Genéticas Congénitas/tratamiento farmacológico , Oligonucleótidos Antisentido/uso terapéutico , ARN Interferente Pequeño/uso terapéutico , Humanos , Oligonucleótidos Antisentido/genética , Preparaciones Farmacéuticas , ARN Interferente Pequeño/genéticaRESUMEN
A consortium of seven pharma companies has been formed with the aim of sharing knowledge on and harmonizing approaches to oligonucleotide development. This letter aims to raise awareness of this new group and to set expectations for future publications.