Course Description:
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.
The live version of this recording took place on March 5, 2021 and features
a presentation by Nadim Akhtar, 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.