Prof. Dr. John F. Carpenter (University of Colorado) has joined our scientific advisory board. As one of the leading experts in protein formulation science, protein degradation, subvisible particle analytics and immunogenicity of protein aggregates he will be available for our customers to give his scientific input for the projects.

Archimedes (Affinity Biosensors) and Coulter Counter (Beckmann Coulter) have been established at Coriolis Pharma for the analytical characterization of subvisible aggregates and particulates.

Archimedes is a novel technology for subvisible aggregates and particles in the size range between ~40 nm to 5 µm. The technique determines size, mass, volume and density of individual particles at high resolution, accuracy and reproducibility using a sample volume as low as 100 µl. A striking advantage of the technology is the possibility to distinguish between proteinaceous and non-proteinaceous particles, e.g. silicone droplets based on the density difference. Coulter Counter can size and quantify particles in the size range between 400 nm and 1200 µm. Especially for translucent protein particles, where light-based techniques (e.g. light obscuration or flow imaging techniques) have limitations due to the refractive index difference between the particles and the formulation, Coulter Counter measurements can be highly valuable.

With those novel techniques in hand, we can generate a very comprehensive and strong CMC data package for our customers, which will be highly appreciated by the regulatory authorities.

Micro-Flow Imaging, light obscuration and asymmetrical flow field flow fractionation (AF4) and hollow fiber flow field flow fractionation (HF5) can now be offered as GMP analytics for our customers.