Coriolis Pharma offers Analytical Ultracentrifugation (AUC) for biologics and virus-based drug products from early-stage development to post-market monitoring. Coriolis is now preparing forinspection by the competent surveillance authority for the confirmation to perform AUC services in compliance with GMP. The first clients have already started their projects.
MARTINSRIED-MUNICH, Germany, March 06, 2024, Coriolis Pharma, a globally operating service provider for drug product development,analytics and manufacturing support, proudly announces the introduction of Analytical Ultracentrifugation (AUC) under GMP. With the introduction of this method under GMP, Coriolis meets the increasing demand in the pharmaceutical and biotech industry and expandsits existing portfolio of GMP methods for the development of high-quality drug products.
AUC has long been recognized as a powerful technique, even a gold standard, for the detailed study of macromolecules, including proteins, nucleic acids, viral vectors, and nanoparticles. Its ability to provide precise information on aggregation,molecule size, shape and interactions has made it indispensable in the field of biophysical characterization.
"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," said Dr. Frank Schaubhut, Head of Operations at Coriolis Pharma. "We’re proud to take our expertise to the next quality level with introducing this service under GMP.”
From the early development to post-market monitoring: AUC has proven its versatility in the various phases of drug development: Formulation development, quality control, comparability studies or post-marketing surveillance. It is thereforean important addition to Coriolis' comprehensive range of phase-appropriate analytical services under GMP, which also includes method development and validation, compendial method verifiation, release testing, tech transfer support, and stability testing.
Coriolis' commitment to high-quality, innovation and scientific excellence has earned the trust of leading biopharmaceutical companies worldwide. By partnering with Coriolis for GMP analytical services, companies can accelerate their timeto market, reduce costs and mitigate risks associated with product quality and regulatory compliance.