Case Study

BioSpring Implements Compliance-Ready LC-MS Workflows For Oligonucleotides To Expand Existing Portfolio

BioSpring Waters Inc

Since 1997 BioSpring, a CMO located in Frankfurt, Germany, has been providing reliable analytical solutions for commercial therapeutic and late-stage oligonucleotides, as well as preclinical, diagnostic, and R&D applications.

BioSprings oligonucleotides are used for applications like antisense, siRNA, conjugates and long single-stranded RNA. In the past four years, the company has charted a rapid expansion plan as demand for its products and services has increased due to technical advances in oligonucleotides synthesis and more research activity in synthetic biology.

For oligonucleotides developed as therapeutics of for clinical diagnostics, BioSpring's QC department must follow regulatory requirements to confirm product ID, sequenced and purity. With therapeutic modalities comes the added requirement of identifying, characterizing, and quantifying low-level impurities as well as pre-clinical and clinical drug metabolism and pharmacokinetics (DMPK) studies to ensure drug safety and efficacy.

BioSpring began to look for solutions to cover their needs for characterization workflows covering data aquisition, processing and reporting which eventually led them to Waters.

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