“This milestone represents the first cGMP batch for Acasti on this continuous manufacturing line, which proves that the continuous manufacturing process in CordenPharma Chenôve is well-placed and capable of producing cGMP material, much like the first flight for a new plane proves its design,”Yves Michon, CEO at CordenPharma Chenôve, told Outsourcing-Pharma.com
“This milestone demonstrates CordenPharma’s mindset of innovation and flexibility by engineering an innovative continuous manufacturing process, and reacting to the demands of the project in a flexible and efficient manner,” he added.
Michon explained the advantage of the continuous manufacturing line is that scaling up to meet demand is simple – “just run the equipment for longer,” he said. “This dramatically reduces costs associated with scale-up and process re-validation for Acasti and future customers.”
As previously reported, the proprietary continuous manufacturing process was developed in partnership between CordenPharma and Acasti Pharma.
“When the partnership began, both teams of engineers came together with their respective expertise to extend their knowledge, where Acasti gained insight into continuous process engineering from CordenPharma Chenôve’s previous experience, and CordenPharma Chenôve learned the manufacturing particularities and know-how of Acasti’s CaPre product,” Michon explained.
Acasti’s CaPre product candidate is being prepared for Phase III clinical trials later this year.
CordenPharma will continue executing the continuous flow process to obtain additional quantities of cGMP material, Michon explained, before eventually stepping up to Acasti’s anticipated commercial quantities once they gain approval from CaPre’s marketing application.