Acasti Pharma and CordenPharma announce large-scale production of CaPre with continuous manufacturing

Continuous manufacturing process will enable improved quality control and cGMP compliance, while reducing energy consumption, waste and raw material.

“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, 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 commercialize 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, CEO 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.”