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Ensuring Reliable Results Method Development & Validation
Analytical Services

Method Development & Validation

BioSpring uses over two decades of know-how and experience paired with the most advanced analytical equipment available on the market to develop robust analytical solutions adapted to your unique molecules. Working with cutting-edge analytical equipment from all leading manufacturers allows also for an efficient transfer of analytical methods to BioSpring, if required. 

Our analytical development and validation capabilities include:

  • Release, stability, and characterization testing for oligonucleotides
  • Raw material method development and validation
  • High-resolution LC-MS(/MS) method development and validation
  • Biochemical and pharmacokinetic assay development and validation

Our team of analytical experts have developed, implemented, optimized, and validated hundreds of sequence- and structure-specific high-resolution methods. For commercial and clinical applications, we validate these methods using a customized, stage-appropriate approach compliant with ICH guidelines.

Our Analytical Development & Validation Services

  • Development and validation of purity- and stability-indicating analytical methods for oligonucleotide drug substance and drug product
  • Development and validation of high-resolution LC-MS methods
  • Cutting-edge characterization methods for oligonucleotides
  • In-house synthesis of standards and oligonucleotide-specific impurity markers for method development/testing for specificity
  • Forced degradation studies
  • In-use and solution stability studies
  • Establishment of validation parameters and specifications
  • Development and validation of analytical methods for raw materials, including for customer-specific and customized raw materials
  • Biochemical and pharmacokinetic assay development and validation
  • A stepwise validation approach adapted to our clients’ therapeutic program stages
  • Analytical validation programs for commercial products


 Have a question or need a quote? Contact us


Learn more about our Analytical Services