Acasti and CordenPharma look to continuous production for omega-3 drug
Acasti Pharma announced last week the first cGMP batches of its lead candidate CaPre (omega-3 phospholipid) have been produced using a continuous process installed at a facility in Dijon, France.
The candidate is made from krill oil which the firm says reduces triglycerides, providing benefits on LDL-C and HDL-C in patients with severe hypertriglyceridemia.
The process, jointly implemented by Acasti and its contract manufacturing organisation (CMO) CordenPharma is designed to purify the bioactive molecules of the raw krill oil through continuous and consecutive decantations.
“The new process allows for reduced cycle time for making the drug substance, a smaller equipment footprint and storage costs, reduced in-process sample collections and increased throughput by two to three folds, in comparison to a batch process,” an Acasti Pharma spokesperson told this publication.
“The process is proprietary and installed specifically for the development of CaPre.” The firm did not disclose cost information when asked.
The news was described as an “important milestone” by the company in the clinical development of CaPre. The candidate is being prepared for Phase III trials later this year.
Continuous manufacturing is increasingly being looked at as an alternative to batch production across the pharma industry, and has had several breakthrough moments over the past few years: endorsement from the US FDA, for example, as well as regulatory approval for J&J of a change in its s production method of HIV drug Prezista from batch to continuous.
However, the need for clear regulations, recruitment issues and the costs and risks of refitting facilities continue to hold the industry back from fully embracing such technologies.
