Introduction and Contents

Introduction

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.

Jump to any article using the contents on the following page, or at any time using the Contents menu in the top left. There you can also download this eBook as a PDF.

1. 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.

2. 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.

3. 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.

4. 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.