In a recent interview with TIDES, Andrew Teasdale, AZ Impurities Advisory Group Chair, AstraZeneca, United Kingdom examines the scope and applicability of both new guidance (ICH Q3D and ICH M7) and existing guidance (ICH Q3A / Q3B) to Oligonucleotides, looking into practical challenges and how they might be addressed and the potential application of generic, platform risk assessment approaches.
When discussing the impurities that face oligonucleotide developers, Andrew said, "The most common impurities in oligonucleotides are still related substances (oligomeric impurities)". However, this still begs to question what does one need to consider when mitigating risk for these impurities? Access the complete interview now.
To learn more from Andrew about oligonucleotide impurities, join him at IBC's 18th Annual TIDES event this May in Long Beach, CA where he will be speaking in his session titled "Assessment of the Relationship of Impurity Guidelines to Oligonucleotides - Opportunities for Rationale Approaches to Management of Risk". Download the brochure to access the complete agenda and speaking faculty.
Register for TIDES now and save $500 - To activate your savings, use the code B16180BLOG100
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1 comment :
thanks for Impurity Guidelines to Oligonucleotides. Really useful to get new thoughts. www.angelmeds.com/blog
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