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Analytical services

Nucleic Acid Analytics and Quality Control

BioSpring is the industry‘s trusted partner for release testing, stability studies, and characterization of oligonucleotides (API and Drug Product). We offer tailor-fit solutions adapted to your therapeutic program‘s stage from R&D and early therapeutic development to market approval and beyond.

  • Analytical Quality by Design (AQbD) meeting ICH Q14 requirements
  • Advanced state-of-the-art methods like high-resolution LC-MS, LC-MS/MS, MS/MS sequencing, and NGS
  • Flexible stepwise validation approach - early stage to commercial
  • Analytical methods for raw materials including custom raw materials 
  • 9 laboratories and teams for late-stage programs, analytical method development, microbiology and bioanalytics 

Supporting the entire drug development process.

Process-Steps

 

 

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Learn more about our Analytical Services