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
- 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
CRS Germany, Bad Dürkheim, Germany, February 29 - March 1, 2024
Daniel Kumar, Thomas Vrucina
European Symposion on Controlled Drug Delivery, Egmond aan Zee, Netherlands, April 10-12, 2024
Dr. Andreas Wagner
TIDES USA, Boston, USA, May 14-17, 2024
Thomas Vrucina, Dr. Andreas Wagner
Applied Biophysics Forum
in Drug Delivery, Copgenhagen, Denmark, May 27-28, 2024
Dr. Andreas Wagner
Levitronix Bioprocessing Conference, Cambridge MA, USA, June 20, 2024
Dr. Andreas Wagner
Liposome Research Days, Glasgow, UK, June 26-29, 2024
Thomas Vrucina, Dr. Andreas Wagner
mRNA Health, Boston, USA, November 12-14, 2024
Thomas Vrucina, Dr. Andreas Wagner