You are using IE 8 or below so some features may not work. Please upgrade to a modern browser
Ihr Webbrowser ist veraltet und wird leider nicht in vollem Umfang unterstützt.

Analytical Methods

A wide range of analytical methods is available for testing of intermediates, APIs and finished drug products. They can be readily adapted for new products. Qualification and validation of analytical methods for each project are performed according ICH guidelines.
A list of the main methodological groups is given below. Additional methods are organised with qualified contract analytical laboratories.

Microbiology

  • sterility (external)
  • bioburden

Electrophoresis

qualitative and quantitative using a wide range of detector systems, e.g. fluorescence, chemiluminescence

  • sodium dodecylsulfate polyacrylamid gel electrophoresis (SDS-PAGE)
  • isoelectric focusing (IEF)
  • Western blot
  • 2D electrophoresis
  • fluorescence 2D difference gel electrophoresis (2D DIGE)
  • capillary electrophoresis (CE)

Microtiter Assays

  • enzyme linked immunosorbent assay (ELISA)
  • protein activity assay
  • host cell protein
  • protein A
  • endotoxin
  • enzyme activity assay

Instrumental Analytics

all conventional separation methods in combination with various detector systems (e.g. CAD, UV, refractive index, fluorescence)

  • high performance liquid chromatography (HPLC), e.g. SEC, AEX, CEX, RP, IP/RP
  • capillary electrophoresis (CE)
  • optical density (OD)
  • fourier transform infrared spectroscopy (FTIR)
  • DNA threshold method
  • fluorescence spectroscopy

Cell Culture Analytics

  • mycoplasm (by DNA staining and chemiluminescence)

In Vitro Test Systems

  • proliferation assays, e.g. using MTT, XTT, BrdU

Microscopy

  • fluorescence microscopy
  • phase contrast microscopy

Others

  • osmolality
  • conductivity
  • pH
  • subvisible particles (HIAC)
  • density
  • residual moisture (Karl Fischer)
  • visual appearance
  • TOC

Analytical Methods

MEET US AT

13th International mRNA Health Conference, Berlin, Germany,
November 11-13, 2025

Thomas Vrucina, MSc
Dr. Andreas Wagner