As the demand for precision in oligonucleotide-based drug development grows, advancing innovative and robust analytical tools is critical. Effectively tackling challenges such as impurity profiling, structural analysis, deep sequencing, toxicity, fundamental biology, and comparability is essential to developing these complex therapeutics safely and effectively.
Nucleic Acid Insights has assembled a panel of leading experts in oligonucleotide analytics to explore the latest strategies and technologies addressing these hurdles.
The panel will explore novel impurity grouping strategies, discuss how regulatory expectations are evolving, and share insights on the innovations likely to shape oligonucleotide analytics over the next five years.
• Understand current strategies for impurity characterization in oligonucleotide therapeutics using advanced tools such as liquid chromatography–mass spectrometry (LC-MS) and high-performance liquid chromatography (HPLC)
• Gain insights into the role of deep sequencing and single-strand analysis in assessing stability, quality, and degradation of RNA-based drugs
• Explore how evolving regulatory expectations and emerging technologies are influencing analytical approaches and comparability studies
Thomas Minshull
Postdoctoral Researcher at The University of Sheffield
Dr. Tom Minshull is a postdoctoral researcher at the University of Sheffield, working with Prof. Mark Dickman and Dr. Zoltan Kis. With a PhD from the University of Sheffield, his early research used mass spectrometry to investigate post-translational modifications of histone proteins in the context of sepsis. After completing his PhD, Tom spent over five years in industry as a senior scientist at Porton Biopharma and Immunocore, developing analytical methods for a wide range of biopharmaceuticals, from vaccines to anti-cancer therapeutics. He then returned to academia at the University of Leeds, where he managed a mass spectrometry facility and developed biophysical and structural proteomic techniques to understand how RNA impacts protein amyloid formation.
His current work at Sheffield focuses on leveraging this broad expertise to develop new analytical tools to characterise mRNA for biotherapeutic applications.
Afaf EI-Sagheer
Professor at University of Southampton
Afaf studied her PhD in chemistry at Southampton University with Professor John Mellor then moved back to Egypt to become a lecturer then Professor at Suez University. She was a Research Fellow at Southampton University from 2006-2013 followed by a Senior Research Fellow at Oxford University from 2013-2022 working with Professor Tom Brown. She is currently an assistant professor at Southampton University working in the area of therapeutic oligonucleotides and modified mRNA and their targeted delivery. Afaf has expertise in therapeutic oligonucleotides synthesis, HPLC purification and characterisation. Afaf also has long term expertise in sequencing, biophysical, biochemical and cell studies. She has pioneered click chemistry and other synthetic methods to assemble novel, long and modified biocompatible DNA/RNA constructs for custom gene synthesis/editing and their applications in biology and medicine. Some of the reagents she developed are commercially available from Glen Research and the work was highlighted on National DNA Day and in research outreach.
She has more than 190 Peer-reviewed publications including high impact journals such as (Science, Nature Chemistry, Nature Str. & Mol. Bio., Nature Commun., JACS, PNAS, Angew. Chem.), patents and book chapters with H-index 48 and more than 7800 citations (Google Scholar). She was invited to give talks in UK, many countries in Europe, USA and China.
Mike Webb
Independent Consultant at Mike Webb Pharma
Mike Webb has over 40 years of experience in CMC development of API from late discovery to file and launch and beyond. In his former role as Vice President of API Chemistry and Analysis UK for GSK, he led a department of 150 scientists. Had has been closely involved in 8 worldwide marketing submissions. Mike also has a publication record in Analytical Sciences, including papers, book chapters, podium presentations at international meetings, and has edited 3 books.
More recently, Mike has taken a specific interest in the chemistry, analysis, manufacturing, and registration of therapeutic oligonucleotides. After leaving GSK in 2016, he has been consulting on CMC matters mainly pertaining to oligonucleotide development, analysis, and manufacturing with both biotech and big pharma companies. He focuses on covering therapeutic product and process understanding and associated manufacturing, analysis, regulatory, and quality issues.
