Modalities and Stability Studies

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Modalities

Integrity Bio has experience with various biological drug products such as:

  • Proteins
  • Antibodies
  • Peptides
  • Oligonucleotides
  • Vaccines
  • Viral Particles
  • Plasmid DNA
  • Lipid nano particles

Stability studies

Regulators require stability studies to show that your drug product is safe and effective during its shelf life.  While accelerated stability studies are useful for predicting potential degradation products and appropriate analytical methods, they are not sufficient for regulatory approval.  Integrity Bio has wide ranging experience in performing both accelerated and real-time stability studies.