Analytical Ultracentrifugation for Release Testing

Analytical ultracentrifugation

Coriolis Pharma offers analytical ultracentrifugation, or AUC for short, for biological and virus-based drugs from the early development phase through to post-market surveillance. Coriolis is currently preparing for inspection by the relevant regulatory authority in order to obtain the certificate for the provision of AUC services in accordance with GMP guidelines. The first customers have already started their projects. With the introduction of this method under GMP, Coriolis is responding to the increasing demand in the pharmaceutical and biotech industry and is expanding its existing portfolio of GMP methods for the development of high-quality pharmaceutical products.

Analytical ultracentrifugation has long been recognised as a powerful technique and even the gold standard for the detailed study of macromolecules such as proteins, nucleic acids, viral vectors and nanoparticles. The ability to provide precise information on aggregation, molecule size, shape and interactions has made AUC an indispensable tool for biophysical characterisation.
"Coriolis has been a world leading specialist for biopharmaceutical method development and testing by using AUC for almost a decade, featuring all available combinations of state-of-the-art AUC hard- and software," says Dr. Frank Schaubhut, Head of Operations at Coriolis Pharma. "We’re proud to Coriolis Pharma is a global contract research and development organisation and is also active in the formulation research and development of pharmaceutical and biopharmaceutical drugs, including cell and gene therapy products and vaccines.

Analytical ultracentrifugation complements phase-specific analytical services

From early development to post-market surveillance, AUC has proven its versatility in the various phases of drug development: Formulation development, quality control, comparability studies or post-marketing surveillance. For Coriolis, it is therefore an important addition to its comprehensive range of phase-specific analytical services under GMP conditions, including method development and validation, compendial method verification, release testing, technology transfer support and stability testing. Coriolis' commitment to high quality and scientific excellence has earned the trust of leading biopharmaceutical companies worldwide. By working with Coriolis in the area of GMP analytics, companies can bring their products to market faster, reduce costs and minimise risks associated with product quality and regulatory compliance.