Automating QC of Therapeutic Oligonucleotides in a Regulated Manufacturing Environment Background Bayer Pharmaceuticals obtained an exclusive license from Ionis Pharmaceuticals to develop new oligonucleotide-based treatments for a wide range of medical conditions. To support release testing and the imminent clinical trials of an advanced drug candidate, the Bayer Analytical Development Team for Biologics was tasked with implementing a validated drug substance and drug product release ID test that required establishing new analytical methods, standard operating procedures, and organizational responsibilities. The tight go-live timeline and anticipated costs of any delay led Bayer to work together with our long-term partner Genedata to develop a confirmatory identification (ID) workfl

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