Acasti Pharma Inc. has announced the achievement of a major corporate milestone by manufacturing the first cGMP batches of CaPre, Acasti’s omega-3 pharmaceutical product candidate, produced with a proprietary and innovative continuous manufacturing process developed in partnership with CordenPharma.
CaPre is a potentially best-in-class omega-3 drug derived of krill oil and being developed for the treatment of patients with hypertriglyceridemia, a metabolic condition that contributes to the risk of cardiovascular disease and pancreatitis.
The process was jointly designed and implemented by the Acasti and CordenPharma technical teams and engineers at the CordenPharma Chenôve facility in Dijon, France.
“The development and implementation of this continuous manufacturing production line is evidence of the terrific progress Acasti is making as we prepare to initiate Phase III trials of CaPre in late 2017,” said Pierre Lemieux, PhD, Chief Operating Officer of Acasti Pharma.
“It was a successful joint effort involving Acasti and CordenPharma to design and execute a process that paves the way for the development and future commercial manufacturing of CaPre as a potential treatment for patients with severe hypertriglyceridemia. This is an important milestone in Acasti Pharma’s program to develop and commercialise CaPre.”
This continuous manufacturing process allows for the production of CaPre with an increased throughput and a small equipment footprint.
The process is designed to purify the bioactive molecules of the raw krill oil through continuous and consecutive decantations.
This approach will enable improved quality control and cGMP compliance, while reducing energy consumption, waste and raw material, in a cost-effective manner that aligns with the FDA’s championing of robust, flexible and efficient continuous manufacturing processes.
“We worked closely with Acasti Pharma to design and engineer a unique and innovative continuous manufacturing process for CaPre,” said Yves Michon, Chief Executive Officer of CordenPharma Chenôve.
“This process has been installed at CordenPharma Chenôve and will allow us to efficiently scale-up the volume of CaPre needed for Acasti‘s Phase III trial and early commercial demand. We are honored to continue working with them.”