Analytical equipment
Coriolis Pharma is equipped with modern, state-of-the-art equipment for the analytical characterization of biologics, with respect to purity, chemical changes, aggregation, particle formation, thermal stability and structure:
- Archimedes --- NEW ---
- Coulter Counter --- NEW ---
- Hollow fiber field flow field fractionation (HF5) with MALLS, RI and UV detection --- NEW ---
- Various high-performance liquid chromatography (HPLC) systems for SEC, IEX, RP-HPLC with UV, fluorescence and RI detection
- Asymmetrical flow field flow fractionation (AF4) with UV and multiangle laser light scattering (MALLS) detection
- Capillary isoelectric focusing (cIEF)
- SDS-PAGE, Western Blot
- Dynamic light scattering (DLS) in plate reader and cuvettes
- Zeta potential
- Light obscuration (Ph. Eur./USP and volume reduced methods)
- Nanoparticle tracking analysis (NTA) by Nanosight®
- Flow microscopy (Microflow imaging™ MFI)
- UV-Vis spectroscopy in plate reader and cuvette
- Fluorescence spectroscopy in plate reader and cuvette
- Circular dichroism spectroscopy (Far- and Near UV)
- Fourier transform infrared (FTIR) spectroscopy for liquid and solid samples
- Infrared microscopy
- Microcalorimetry
- Turbidity
- Visual inspection (Ph. Eur)
- Light microscopy
For a rational lyophilization cycle development we include the physico-chemical properties of the formulations in the frozen state and in the dried state into the process development. Methods used in this context are:
- Differential scanning calorimetry (DSC)
- X-ray powder diffraction (XRD)
- Karl Fischer titration
- Scanning electron microscope (SEM)
For general characterization of physico-chemical properties of formulations we can offer the following techniques:
- pH measurements
- Osmolarity / osmolality
- Appearance and color (Ph. Eur.)
- Rheometers (capillary and cone-plate) to determine the viscosity
- Texture analyzer
- Syringeability testing