With the introduction of this method under GMP, Coriolis meets the increasing demand in the pharmaceutical and biotech industry and expands its existing portfolio of GMP methods for the development of high-quality drug products.
AUC has long been recognised 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 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," said Dr Frank Schaubhut, Head of Operations at Coriolis Pharma.
"We’re proud to take our expertise to the next quality level by 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 therefore an 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 time to market, reduce costs and mitigate the risks associated with product quality and regulatory compliance.