Analytical Method Development

Sterin Labs is the scientific expert in analyzing biopharmaceutical product samples. From high concentration antibodies to low concentration hormones; from early-stage drug substance to complex late-stage drug products: We consider the specific needs of your project and your analytical challenge, and tailor for you the most suitable set of cutting-edge analytical strategy and methods.

Our analytical portfolio comprises 100+ different techniques – all performed by Sterin’ experts in-house. Our analytical scientists have unmatched know-how in their field and able to push the limits of what’s possible. We put together a dedicated method development plan tailored to your analytical challenge and include orthogonal techniques, if desired and where appropriate, to not leave any blind spots in our results.

Process Capability

  • HPLCs (with UV, PDA, ELSD & RI detectors)
  • UV-Visible Spectrophotometry
  • Gas Chromatography
  • Water Activity and Moisture Quantification
  • Viscosity Measurement

Analytical Services

  • Analytical Method Development
  • Method Validation to Support Regulatory Filing
  • ICH Stability Studies
  • Solid State Characterization
  • Development of Cleaning Method
  • Analytical Method Transfer

Let's talk!

Speak to our experts and learn how you can benefit from our science-drive development services.