Well placed and capable continuous manufacturing process, says CEO

0


This step represents the first cGMP batch for Acasti on this continuous manufacturing line, proving that CordenPharma Chenôve’s continuous manufacturing process is well positioned and capable of producing cGMP material, just as the first flight of a new aircraft proves its conception“, said Yves Michon, CEO of CordenPharma Chenôve, to Outsourcing-Pharma.com

This milestone demonstrates CordenPharma’s spirit of innovation and flexibility by designing an innovative continuous manufacturing process and reacting to project requirements in a flexible and efficient manner.“, he added.

(Image: CordenPharma)

Michon explained that the advantage of the continuous manufacturing line is that it is easy to scale to meet demand. – “just keep the equipment running longer“, did he declare. “This dramatically reduces the costs associated with scaling and revalidating processes for Acasti and its future customers.

As previously stated, the proprietary continuous manufacturing process has been developed in partnership between CordenPharma and Acasti Pharma.

When the partnership began, the two engineering teams came together with their respective expertise to expand their knowledge, where Acasti gained insight into continuous process engineering through previous experience of CordenPharma Chenôve, and CordenPharma Chenôve learned the specifics of manufacture and know-how of the CaPre product from Acasti.”Michon explained.

Acasti’s product candidate CaPre is being prepared for Phase III clinical trials later this year.

CordenPharma will continue to run the continuous flow process to obtain additional amounts of cGMP material, Michon explained, before ultimately switching to the commercial amounts expected by Acasti once they obtain approval for CaPre’s market application.


Share.

Comments are closed.