Whilst applying a broad array of high-throughput technologies, we provide rapid formulation development accompanied by simultaneous real-time and accelerated stability testing according to ICH standards.
We use a semiautomatic filling machine to determine critical process parameters and to produce aseptic drug product for preclinical studies.
- Particle detection and morphology: DLS, SEC-UPLC, MFI, light obscuration and visual inspection
- Conformational change by DSC & FT-IR
- Chemical stability with a broad array of UPLC and mass spectrometry-based methods