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.

Liposomes/LNPs

• size / size distribution (polydispersity index)
• zeta potential

Microbiology

• sterility (external)
• bioburden

Electrophoresis

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

• sodium dodecylsulfate polyacrylamid gel electrophoresis (SDS-PAGE)
• isoelectric focusing (IEF)
• Western blot

Microtiter Assays

• enzyme linked immunosorbent assay (ELISA)
• protein activity assay
• 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)
• fluorescence spectroscopy
• photon correlation spectroscopy
• zeta potential

In Vitro Test Systems

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

Others

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