Methods Development and Validation. Analytics

“Robust methods from development to commercial, including protein characterization and bioassays”

 

  • Lab9299UnaiAnalytical quality control services including:
    • Environmental monitoring
    • Pharmaceutical waters (PW, CS, WFI) testing
    • Raw materials testing
    • Packaging materials testing
    • Active Pharmaceutical Ingredient (DS) analyses
    • In-Process Controls
    • Final product (DP) analyses
  • Official methods (Eur. Ph., USP, or international Pharmacopoeias) implementation.
  • Complete development, qualification and validation of analytical methods to comply with international guidelines (ICH, EMA, FDA, etc.).
  • Analytic methods transfer.
  • Stability studies according to ICH guidelines.
  • Analytical capacities::
    • High performance liquid chromatography (HPLC): RP, SEC, NP, IEX, etc.
    • Peptide mapping
    • UV-Vis spectrophotometry
    • Total organic carbon (TOC)
    • Potentiometric analyses (pH, conductivity)
    • Water content (Karl-Fischer)
    • Osmolality
    • Subvisible particles
    • Potential Z
    • Total protein (Bradford, BCA, extinction coefficient, etc.)
    • Electrophoresis SDS-PAGE
    • Isoelectric focusing (IEF)
    • Western Blot
    • ELISA
    • Cell Proliferation assays (Bioassay)
    • Bioburden (TAMC, TYMC)
    • Bacterial endotoxins (Chromogenic kinetic method)
    • Bacterial strains identification
  • Partners for other protein characterization testing (e.g. Mass Spectrometry)

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