Oligonucleotide drugs are a special class of therapeutics that are not explicitly covered by the regulatory and CMC guidance which cover low molecular weight therapeutics. This presentation discusses some of the regulatory challenges for synthetic oligonucleotides seen in INDs and NDAs. In particular, the regulatory issues for Manufacturing, Characterization and Control of Drug Substance are discussed.

Subject area:
Biologics

Objectives (If applicable):
na

Target Audience (If applicable):
– Regulatory scientists
– Analytical scientists
– Quality assurance analysts
– R&D scientists and managers
– Quality control analysts
– Contract research organizations