In-depth analytical characterization of drug substance and drug product stability using state-of-the-art equipment paired with high-end sophisticated technologies.
In-depth analytical characterization of drug substance and drug product stability (physical, chemical, and physico-chemical stability) in dedicated preparative and analytical laboratories, physically separated for biologics, cytotoxics and live viral vaccines.
Physico-chemical stability screening by high-throughput stability predictive technologies: i.e. DLS, nanoDSC, CG-MALS
Chemical and physical stability by chromatographic analysis: i.e. SE-HPLC, reduced/non-reduced RP-HPLC, IEX-HPLC, HI-HPLC, AF4, UPLC + all common detectors (i.e. UV, RI, DAD/PDA, TDC, MALS, ELSD, LIF, FID, MSD)
Physical stability by spectroscopic analysis: i.e. UV-spectroscopy, nephelometric turbidity, sub-visible particles by light obscuration (LO) or micro-flow imaging (MFI)
Chemical stability by electrophoretic analysis: i.e. cGE, reduced/non-reduced CE-SDS, reduced/non-reduced SDS-PAGE, IEF, cIEF
ÄKTA for pilot scale protein purification
Cross-flow UF/DF device for concentration and process evaluation
Syringeability determination for high concentration protein formulations
Lyophilization: i.e. thermal characterization by DSC, critical pressure scanning (CPS), HOF pilot freeze dryers equipped with process analytical technologies (PAT), Karl Fischer titration for residual water content incl. discrimination of crystalline- and adsorptive-bound water, HS-GC-MS for residual organic solvent identification and content determination, scanning electron microscopy (SEM) for in-depth structural analysis of lyo cakes
Measurement of protein absorption coefficient in dependence of solvent and wavelength including glycosylation content determination