Quality is key, in everything we do.
GMP compliant analysis is performed on qualified instruments and utilizes carefully developed and comprehensively validated methods. Full GMP documentation and involvement of Quality Management allows us to perform lot release analysis and generate supportive data for market approval.
Regulatory requirements for aggregates and particles
Protein aggregates and particles can be very heterogeneous in their size, ranging from few nanometers up to visible particles of > 100 μm. We at Coriolis understand that an orthogonal approach for analyzing aggregates and particles is crucial to assure the optimum stability of a formulation. Furthermore, we observe that authorities as well as customers more frequently wish such studies to be conducted in a quality-controlled environment. This ensures a maximum in data integrity, traceability and documentation.
Coriolis has received cGMP accreditation by the local regulatory authority for selected protein aggregate and particle characterization techniques, and since then we have been re-inspected by the authority and audited by several clients successfully.
"Enhanced R&D" level studies
Within our GMP setup we also serve customers requesting performance of non-GMP studies in a controlled (GMP) environment. This permits the utilization of fully qualified equipment but still allows the flexibility of an R&D project. The quality level can be tailored to customer needs.
Read more about our GMP analytical services: