Principal Scientist - Characterisation & Control Strategy AstraZeneca Macclesfield, United Kingdom
Recent EMA guidance on terminal sterilization requires a substantial effort to enable terminal sterilisation of parenteral products and has raised the bar for data required to justify an aseptic filtration process. The guidance exclude biological products, however, synthetic oligonucleotides are not biological products and therefore the guidance is applicable. This presentation will discuss challenges associated with terminal sterilisation of oligonucleotides with special focus on degradation products generated as a result of exposure to high temperature during terminal sterilisation. Considering ICH Q3a and ICHQ3b do not apply to oligonucleotides the presentation will discuss strategies for using degradation data for selection of appropriate sterilisation method.
Upon completion, participants will have an increased awareness of the recent EMA guidance on terminal sterilisation and its implications for oligonucleotide drug products
Upon completion, participants will understand oligonucleotide degradation pathways and various factors that impact the rate of degradation
Upon completion, participants will understand strategies for control of impurities in oligonucleotide drug products
Upon completion, participants will learn about various factors that should be considered when selectinga sterilisation method for the parenteral product