Advanced Analytical Methods for Oligonucleotide ID Testing in Pharmaceuticals QC
In the pharmaceutical industry, all starting materials and the active pharmaceutical ingredients (APIs) of a drug product must be subjected to analytical identity (ID) testing as part of the release prior to their introduction into the pharmaceutical manufacturing process. For quality control laboratories in general—and particularly for a contract development and manufacturing organization (CDMO) handling a wide variety of materials—it is preferable to perform ID tests using a simple, fast, highly specific analytical method. This preference also applies to oligonucleotides, an emerging class of APIs, where a combined ID testing strategy should be applied, including intact mass determination and a sequence-specific method.
After a short introduction to oligonucleotides, this webinar will focus on the sequence-specific method and provide a deep dive into the UV-spectrometric determination of the oligonucleotide melting temperature (Tm) using the Agilent Cary 3500 UV-Vis.
Key Learning Objectives:
- Recognize the fundamentals of oligonucleotide melting temperature analysis
- Identify analytical characteristics, potential pitfalls, and how to avoid them
- Learn how the multicell peltier module add-on helps increase efficiency by collecting multiple samples simultaneously
- Understand how an in-cuvette temperature probe with built-in magnetic stirrers improves data quality
- Learn about software built-in features such as smoothing and derivative that can enhance data quality
Who Should Attend:
- Analytical scientists and technicians interested in UV-Vis technologies
- Researchers in oligonucleotides fields
- Quality control specialists for ID testing
- Laboratory managers interested in analytical innovations
Presenter: Alexandra H. Heussner, PhD (Laboratory Manager, Analytical Science Laboratory, Vetter Pharma)
Presenter: Ann Thayer (Contributing Editor, C&EN Media Group)
