Ardena, a specialist pharmaceutical contract development and manufacturing organisation (CDMO), has produced and delivered a new cancer nanomedicine, MBS8, into the clinical phase for its client MonTa Biosciences, in just over a year from end to end.
“We set a pretty demanding timeline for our MBS8 cancer immunotherapy candidate drug and Ardena delivered,” said Simon Skjøde Jensen, CEO of MonTa Biosciences. “They fast-tracked it from pre-clinical to the clinical phase seamlessly, which is impressive considering this technology is a new area of nanoparticle-based cancer immunotherapy.”
Ardena provided the full service, from synthesising the drug substance and formulating it in micelles, to scaling up manufacturing from pre-clinical to clinical phase, and even managed the fill and finish process as well as supply to clinical sites.
“We pride ourselves on being able to deliver a full, integrated package for our clients,” said Harry Christiaens, Ardena CEO. “We are quite unique in that we can integrate our synthetic chemistry and our nanomedicine capabilities. This allows us to specialise in creating and characterizing the building blocks and nanomedicines using our own, GMP-certified manufacturing facilities and fully equipped analytical laboratories,” he explained.
This laser focus on providing a full service requires a high level of collaboration with clients, something made possible thanks to Ardena’s transparency in communication.
“Our clients own their portfolios, and we give them access to our process development and analytical expertise,” explained Mark van Eldijk, Principal Scientist, Ardena. “Having advanced a wide range of nanomedicine formulations into the clinic, we are used to developing new manufacturing techniques and analytical procedures under strict regulatory scrutiny.”
Ardena will continue to work with MonTa Biosciences through the clinical phase providing bioanalytical services and stability studies to ensure there is a new and effective cancer treatment available to patients in need.