Regulatory Considerations for Setting Smart Starting Material Specifications (On-Demand)


Course Description:

Starting material specifications are a key element of the overall control strategy for synthetic oligonucleotides. In this presentation, we share our experience with setting smart specifications that on the one hand are meaningful controls for a specific oligonucleotide sequence and on the other hand enable us to use a platform approach to flexibly source starting materials to multiple oligonucleotide projects.

The live version of this recording took place on March 1, 2021 and features
a presentation by Dominik Altevogt, Ph.D.

Who should participate:

  • Analytical chemists
  • QA/QC analysts
  • R&D scientists, managers
  • Team members in CMC development projects
  • Manufacturing scientists, managers
  • Regulatory affairs specialists
  • Contract research organizations
  • Contract manufacturing organizations

Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.