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 up to BSL-2 viral therapeutics and 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), particle size and number of particles by NTA (10 - 100 nm)
- Chemical stability by electrophoretic analysis: i.e. cGE, reduced/non-reduced CE-SDS, reduced/non-reduced SDS-PAGE, IEF, cIEF, icIEF (iCE3)
- ÄKTA for pilot scale protein purification
- Cross-flow UF/DF device for concentration and TFF process evaluation
- Syringeability determination for high concentration protein formulations
- Lyophilization process: 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
In our advanced analytical services laboratory, we perform methods and applications for ICH Q1 stability testing, accelerated stability study as well as in-use stability testing.