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Physio-Chemical Analysis

These methods focus on impurity identification and content determination of Biologics (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 Chromatograph (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 (OD 280)
  • Conductivity
  • TOC (Total Organic Carbon)

Molecular Biology methods

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

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