Formulation and Fill & Finish Process Development

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.

 

Analytical Capabilities

  • 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

CDMO | DP

Drug Product Manufacturing

We provide a full range of contract biomanufacturing services for both biosimilars and innovative molecules.