Physico-chemical analysis

The physico-chemical laboratory supports Pharma and Biotech companies with a wide variety of methods to determine properties of ATMPs, Vaccines, biopharmaceuticals e.g. antibodies, biosimilars, and chemicals in liquid formulations via qualified or validated U(HPLC) methods according to ICH Q2R1.

Excipient determination e.g. Polysorbate 20, Polysorbate 80, Poloxamer via Evaporating Light Scattering Detector (ELSD)

(Ultra) High Performance Liquid Chromatography via UV/VIS or ELSD

  • Size Exclusion Chromatography (SEC)
  • Reversed Phase Chromatography (RPC)
  • Cation/Anion Ion Exchange (IEX)
  • Hydrophilic Interaction Chromatography (HILIC)
  • Hydrophobic Interaction Chromatography (HIC)

Wet chemistry methods according to ph. eur. / USP e.g.

  • pH determination
  • Osmolality
  • Sub-Visible particles (Particular matter)
  • Coloration (device based)
  • Turbidity (device based)
  • Density determination (device based)
  • Endotoxin determination
  • Visible Particles
  • Extractable Volumes
  • Concentration determination (OD280)
  • Conductivity
  • TOC (Total Organic Carbon)

Molecular Biology methods

  • Gel Electrophoresis
    • Western Blot, SDS-Page (reducing/non reducing), IEF-Page, Agarose electrophoresis for RNA/DNA separation
  • CE (Capillary Electrophoresis)
    • cIEF, CZE, CE-SDS
  • Polymerase Chain Reaction (PCR):
    • Real Time – PCR, quantitative PCR
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