The therapeutic demand of oligonucleotide APIs is rising. In line with increasing production capacities, Bachem drives towards an excellent phase-appropriate quality control strategy of oligonucleotides to meet customer needs. To support process development a lean approach for product-specific method development was designed including design of experiments. MS-compatible, stability-indicating, and robust HPLC methods are the foundation for impurity identification, and subsequent use in release, stability and validation packages.
