Oligonucleotide Manufacturers Keep up with Market Demand using Our Compliance-Ready Instruments

Lisa McLaughlin

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Oligonucleotides have increasingly been used in the scientific community for research, diagnosis of diseases, therapies, forensics, medication discovery, agriculture, and many other applications. Scientific evidence has shown that oligonucleotides are likely to prove effective in treating a variety of medical conditions, which is particularly pertinent to academia, and pharmaceutical and biotechnology companies. Recent developments in techniques for rapid and efficient oligonucleotide synthesis and molecular biology technology have expanded the market for manufacturers and service providers in the field. As the pipeline for RNA/oligonucleotide-based therapeutics continues to expand, so does demand for the manufacturing of Good Manufacturing Practice Certified (cGMP) Oligonucleotides.

Meeting the Expanding Manufacturing Demand: A Client Success Story

BioSpring, a cGMP Contract Manufacturing Organization (CMO) located in Frankfurt, Germany, has developed and manufactured oligonucleotides of the highest quality for its clients around the world since 1997. BioSpring offers services that range from small scale for research and development to large scale for diagnostic applications, late-stage clinical trials, or commercial supplies. BioSpring’s commercial facilities and cGMP system are FDA and EMA approved for the manufacture and analytics of therapeutic oligonucleotides.

Oligonucleotides have increasingly been used in the scientific community for research, diagnosis of diseases, therapies, forensics, medication discovery, agriculture, and many other applications.

Liquid chromatography coupled with mass spectrometry (LC-MS) workflows play a critically important role in the development and manufacturing of oligonucleotides. Biospring had several business strategies to meet the growing demand, including expanding its quality control (QC) services and launching a new laboratory dedicated to bioanalytical services. This requires analytical tools and workflow solutions that can deliver high-quality results, improve efficiency, and enable regulatory compliance.

A Simplified Solution, Designed for Regulatory Submission

BioSpring was interested in the Waters BioAccord LC-MS System because the instrument was developed specifically to meet regulatory compliance requirements. With the BioAccord, BioSpring could achieve the chromatographic resolution, mass resolution, sensitivity, mass accuracy, and linearity required for their wide range of routine biopharmaceutical analyses. BioSpring also liked that the instrument came with optimized compliance-ready workflows, including:

  • Intact mass analysis of proteins and oligonucleotides
  • Subunit analysis of monoclonal antibodies (mAbs)
  • Peptide mapping/multi-attribute-method (MAM)
  • Released N-glycan analysis

Read our latest case study to learn how BioSpring uses the Waters BioAccord LC-MS System, Waters Vion IMS QTof, and waters_connect to ensure data integrity and meet regulatory requirements as the company expands its oligonucleotide manufacturing and analysis services.

Download Case Study

Additional Resources

Blog: BioAccord System with ACQUITY Premier: Some Things Work Better Together

Blog: Answering the Call with Compliance-Ready LC-MS Solutions for Oligonucleotide Analysis