Terminal sterilisation is the process whereby a product is sterilised in its final container. This sterilisation process has always been preferred choice of the regulators. New EMA guidance requires a substantial effort to enable terminal sterilisation of parenteral products and has raised the bar for data required to justify an aseptic sterile filtration process. This guidance also applies to synthetic oligonucleotides. This presentation will discuss specific considerations and challenges associated with terminal sterilisation of oligonucleotides. European Pharma Oligonucleotide Consortium (EPOC) is authoring a position paper on this topic and key recommendations from this paper will also be shared.

Subject area:
Biologics

Objectives (If applicable):
N/A

Target Audience (If applicable):
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