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.

Constanze Schmies is Senior Scientist in the QC Early Phase and joined the Bachem AG in 2020. Her responsibilities are HPLC method development, validations, forced degradation studies, release analytics, and stability testing of oligonucleotide NCE projects. Constanze holds a Master of Molecular Life Science from the University of Nijmegen and a Ph. D. in Pharmacy from the University of Bonn.

Based on decades of experience in applying stirred-bed reactors for making peptides, we investigated how these could be used for the manufacturing of oligonucleotides as well. Attending this talk you will learn more on scalable oligonucleotide manufacturing with stirred-bed technology (SBT) and how Bachem can reach commercial oligonucleotides API production in metric ton range with unbeaten process mass intensity. You will get insights into case studies, Bachem’s SBT capacities for R&D to large scale production projects, and typical CMC activities for scale-up. Finally, the presenter will share the distinct advantages stirred-bed solid-phase oligonucleotide synthesis (SPOS) has over classical fixed-bed SPOS.

Marco Minuth is Director Oligo R&D II at Bachem. He received his PhD in organic chemistry from the University of Stuttgart investigating C-nucleosides for high-fidelity base pairing. He joined Bachem in 2015 as a project chemist in the API division. Since then, he had stages as Group Leader for peptide and later Senior group leader for oligonucleotide CMC development.