Coriolis is a world leading independent contract research and development organization specialized in BIOPHARMACEUTICAL FORMULATION and DRUG PRODUCT DEVELOPMENT including, LYOPHILIZATION PROCESS and ANALYTICAL DEVELOPMENT for proteins, peptides, monoclonal antibodies, RNA/DNA etc., and vaccines. This contains high concentrated protein formulations or developments for subcutaneous administrations or other complex formulations.
This is complemented by outstanding analytical capabilities and know-how in the fields of protein characterization (e.g. higher order structure characterization, aggregation, subvisible particles, surfactant characterization, etc.). Coriolis is expert in highly specialized and innovative analytical technologies (e.g. analytical ultracentrifugation, Resonant Mass Measurement, quantitative Far- and Near-UV CD). Most recently we offer also Polysorbate analytics like quantification and characterization of degradation products.
In addition to that we also offer as standalone services GMP compliant analytics for SUBVISIBLE PARTICLE ANALYSIS and AGGREGATION CHARACTERIZATION (e.g. Light obscuration (LO), Flow Imaging spectroscopy (MFI), Asymmetrical flow field-flow fractionation (AF4) and other innovative techniques.
As of 2017 Coriolis has received the regulatory approval for the operation of a genetic engineering facility of safety level S2 (BSL2), allowing handling of S1 and S2 classified samples.
For gene therapy and viral based vaccine products Coriolis is equipped with state of the art analytical equipmenet to support particle morphology, aggregation, size distribution, and purity analysis using, e.g. AUC, transmission electron microscopy (TEM, nanotracking analysis (NTA), and dynamic light scattering (DLS).
Coriolis is specialized in the provision of
- Formulation development services liquid and lyophilized products
o Pre-formulation and candidate selection
o Early stage formulation development
o Late phase formulation development
o Lyophilization cycle optimization
o Scale – up and transfer studies
- Support in container closure system selection
- In-use stability studies
- Stability testing including forced degradation studies
- R&D and GMP compliant contract analytical services
- Orthogonal analysis of sub-visible aggregates and particles
- Testing of S1 and S2 GMO material
- Outstanding scientific expertise
Coriolis supports customers in R&D development projects, e.g., by developing the most robust formulation or lyophilization process for a biopharmaceutical, identifying suitable stability-indicating analytical methods to monitor real-time and accelerated stability studies, or support in process trouble-shooting.
Freeze-drying capabilities up to 6 sqm shelf area, featuring state of the art process analytical tools, including controlled nucleation, ensure that we develop and optimize lyophilization processes specific for our customer’s needs and ready to be up-scaled, transfer to commercial production units worldwide.
With a strong expertise in aggregate and subvisible particle testing, Coriolis supports in method development and validation for low volume applications (e.g. ophthalmic products) and/or high viscosity material in a GMP compliant environment.
Equipped with several AF4, HP-SEC, multiple AUC´s (including Optima AUC) and DLS systems, Coriolis can perform comprehensive studies on aggregation characteristics.