In recent years, the large molecule drug development market continues to lead the way with double digit growth, driven by various factors such as increase in elderly population, surge in prevalence of chronic diseases such as cancer and diabetes, and the rise in strategic collaborations and funding in the biopharmaceutical industry. Alongside large molecule drug development, oligonucleotide therapeutics is also emerging as an established and validated class of drugs that can modulate a multitude of genetic targets. Since 2016, five oligonucleotides have been approved to treat a range of diseases.
While the new drug development of oligonucleotides shows steady increase, the development of reliable and relatively bioanalytical methods are required to perform the quantitative bioanalysis of oligonucleotides in biological matrix. Method development presents a wide array of challenges. These challenges can range from non-specific binding, ion suppression, ionization efficiency and validation methods to finding the technical expertise required for these unique and sensitive assays
Please join the experts from CMIC Group, Japan’s largest CRO with over 30 years of analytical service experiences in US and Japan, to learn the insights and tips on:
- Developing an immunogenicity assay in a regulated laboratory
- Selecting a format for the neutralization assay for immunogenicity assessments
- Quantitative Bioanalysis of Oligonucleotides by LC-MS