CordenPharma has joined the small but growing cadre of pharma companies adding continuous manufacturing to their mix of manufacturing operations for small-molecule drugs.
The Germany-based CDMO has opened a continuous manufacturing facility at its site in Chenôve, Dijon, France, where it says it has successfully produced the first cGMP batches of an omega-3 pharmaceutical product candidate using technology it developed with client Acasti Pharma.
Acasti, based in Laval, Quebec, says it is taking the drug candidate for the treatment of the high triglycerides condition, hypertriglyceridemia, into phase 3 trials late this year.
The partners said the process is designed to purify the bioactive molecules of the raw krill oil through continuous and consecutive decantations and that the continuous manufacturing process will result in an increased throughput of the product with a small equipment footprint. That will mean less energy and raw materials are needed, and less waste will be generated.
In an email, Yves Michon, CordenPharma Chenôve CEO said, the manufacturing skid is a 21 square-meter assembly that is housed in a 200 square-meter building within the CordenPharma Chenove site.
"This is really the beauty of continuous flow manufacturing – from a relatively small footprint, multi-ton quantities of material can be manufactured, compared to classical batch chemistry which would require a much larger footprint and significant reactor capacity to process an equivalent amount of material,"
A handful of companies have done pioneering work with continuous manufacturing, the production process that is faster, cheaper and less prone to the kinds of manufacturing mess-ups that worry the FDA. The agency urged others to employ the technology after it last year approved the first company switching production of a drug from batch to continuous manufacturing.
In that case, the FDA allowed Johnson & Johnson’s Janssen drug to make the move from batch to the new technology for production of HIV drug Prezista on a line at its plant in Gurabo, Puerto Rico. J&J worked on the technology at the plant for five years.
Eli Lilly last year said it intended to invest nearly $40 million in building a continuous manufacturing facility at its site in Cork, Ireland.
Vertex invested $30 million in a 4,000-square-foot continuous manufacturing facility in Boston to manufacture its cystic fibrosis drug, Orkambi, then last year enlisted Portugal-based contractor Hovione to build a continuous manufacturing plant at its site in New Jersey to make products for Vertex.