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Method development and validation are critical parts of the development of an oligonucleotide manufacturing process. Both tasks are essential parts of the CMC plan. Our team of experts will provide a broad range of tests, develop specific methods for your sequence(s) and then validate them. We have experience with:
- UPLC and HPLC by UV-, RI-, Fluorescence, Radiochem and ELSD-Detection
- LC/MS
- Maldi-TOF MS
- Microbiological Testing including Endotoxins and Bioburden
- Heavy Metals by ICP
- Melting Temperature
- Multi-nuclear NMR, including 1H, 13C, 19F and 31P
- Residual Solvents by Headspace GC
- Sodium content by ICP
- Water Content by Karl Fischer
- Capillary Gel Electrophoresis
- Polarimetry
- UV
- GC/MS
- Titrations
We will develop an impurity identification process that is also important for the specification setting and validation. A forced degradation study is helpful in this impurity identification process and included as a part of all method validation work.
Risk assessment of the analytical methods will address the question of resolution and sensitivity. It answers the question: How good are your analytical methods? We strongly advocate starting this early in the development in order to avoid delays to your program timelines and additional costs.
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