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 Analysis and Quality Assurance


BioSpring is obligated to meet the highest quality standards.

It stands to reason, then, that SOP (standard operation processes) are applied to all analyses. When necessary, these are naturally validated specifically for the product. This, as well as internal and external audits, ensures that our high quality standards are maintained.

BioSpring has a comprehensive infrastructure for conducting product analysis, and we are steadily trying to expand it.

For this reason, we are able to offer a nearly complete spectrum of analyses for characterising oligonucleotides in accordance with the ICH guidelines for GMP products.

Our methods of analysis include:

  • RP-HPLC
  • IP-HPLC
  • IEX-HPLC
  • SEC-HPLC
  • ESI-MS/MS
  • LC-MS
  • MALDI-TOF-MS
  • Sequencing
  • UV-VIS spectrophotometry
  • Tm value
  • Endotoxin content
  • pH value
  • Conductivity
  • Salt content
  • Counterions
  • Differential scanning calorimetry (DSC)
  • Heavy metal content
  • Water content
  • Solvent residue
  • Bases
  • Organic components
  • Duplex mass range


In addition, we also offer stress tests and stability tests in accordance with ICH guidelines.

Certain analyses, such as the measurement of heavy metal content, are done in collaboration with qualified partners whom we audit and qualify.

Feel free to contact us – we are glad to offer our advice ( ).

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BioSpring Analytics


. Analysis and quality assurance
. MALDI-TOF MS
. RNA sequencing

  
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