The two CDMOs sign an alliance to offer an integrated early-development offering and accelerated commercial pathway.
Germany’s Rottendorf Pharma and Canada’s Corealis Pharma have signed an oral solid dose (OSD) manufacturing and development alliance that aims to offer faster, lower-risk development.
The agreement will see the two contract development and manufacturing organisations (CDMOs) offer development capabilities that run from pre-formulation to global market supply.
Laval, Quebec-based Corealis will take the lead with R&D and phase I–II clinical supply while Rottendorf, whose headquarters are in Ennigerloh, North Rhine-Westphalia, will manage phase III, validation and commercial manufacturing.
David Leroux-Petersen (pictured above, centre), CEO of Corealis Pharma, said: “Through this collaboration, we provide our biotech clients a continuous transition from early-stage development to commercial supply – with seamless knowledge transfer.”
Erich Scheibner (pictured above, second from left), Managing Director at Rottendorf Pharma, added: “With Corealis, we have gained an ideal partner for early-stage development who complements our own expertise and expands our reach in this area.”
The new CDMO partnership formalises and extends an existing collaboration, aligning OSD formulation strategy, analytical methods, manufacturing processes and regulatory expectations for the companies’ pharma and biotech clients through a joint execution and governance framework.
