Analytical method development for
(bio)pharmaceutical products
At Coriolis Pharma, we understand that a successful 
(formulation) development of (bio)pharmaceutical products requires sensitive and specific analytical techniques for the detection of chemical and physical instabilities. Our team members are experts in protein analysis, in particular in the field of protein aggregation and degradation. We have currently published a review on Analytical Methods for Particle Analysis in the Journal of Pharmaceutical Sciences, which can be provided to you upon request. For the analytical characterization of (bio)pharmaceutical drugs Coriolis Pharma is equipped with modern, state of the art techniques:
- analytical techniques for protein stability testing: HPLC methods (e.g RP-HPLC, HP-SEC, IEX), SDS-PAGE, cIEF, ELISA, dynamic light scattering (DLS), light obscuration (Ph. Eur./USP), turbidity measurements or visual inspection (Ph.Eur.)
- GMP analytics for MFI, light obscuration and AF4/HF5
- emerging technologies for aggregate and particle characterization: Archimedes, asymmetrical flow field flow fractionation, hollow fiber flow field flow fractionation (HF5) with MALLS detection, nanoparticle tracking analysis (Nanosight®), Coulter Counter and Microflow Imaging™
- structural characterization of proteins: UV-, fluorescence- (intrinsic and with extrinsic dyes), FTIR- and CD-spectroscopy
- microcalorimetry measurements (µ-DSC) to support formulation development
The analytical service of Coriolis Pharma includes:
- development, optimization and validation of analytical methods
- identification and selection of stability-indicating methods
- transfer of analytical methods, incl. detailed SOPs to the customers
- performing service measurements for the customers, which can range from single measurements to long-lasting analytical support for extensive (formulation development, stability) studies
- cGMP analytical service for MFI, AF4/HF5 and light obscuration