Peptides and oligonucleotides have historically incurred control challenges in drug development due to their uniqueness and complexities. With regulatory guidance still slow developing, the best way to avoid impurities is maintaining complete understanding of quality throughout qualifying raw materials, chemistry and downstream processing.
Sponsored by Asahi Kasei Bioprocess, this TIDES eBook focuses on the challenges, strategies and technologies for measuring quality of oligonucleotides and peptides in the processes of therapeutic development. We’ll also explore advice from industry leaders and the uses of mass spectrometry and OPC platforms.
Explore or download the interactive eBook by clicking on the image above or here.
Contents
- The Industry's Biggest Challenges: We surveyed today’s professionals in the peptide, oligonucleotide therapeutics sector on their biggest challenges in meeting regulations in drug development.
- Driving Efficiency and Ingenuity with an OPC Platform: Asahi Kasei Bioprocess America’s Chris Rombach explains how to optimize production processing flows using an OPC (open platform communication) platform.
- Analysis of Antisense Oligonucleotides Using Ultra-high-resolution Mass Spectrometry: We revisit a popular presentation on MS data processing for oligonucleotides provided by Jingshu Xu, PhD, Senior Scientist in Mass Spectrometry, AstraZeneca.
- Analytical and Regulatory CMC for Oligonucleotide Therapeutics: This highlighted presentation by Thomas Rupp provides an overview on the regulatory background of oligonucleotides and analytical considerations for defining CMC control strategies.
Explore or download the interactive eBook by clicking on the image above or here.