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
• plasmid stability

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
• toxicity assays

Microscopy

• fluorescence microscopy
• phase contrast microscopy

Others

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