French contract manufacturer Novasep says that its expansion of its highly potent active pharmaceutical ingredients manufacturing operations at its plant in Le Mans, France, is complete, signed off on by the FDA and now being scaled up for commercial use.
The Swiss drug ingredient and chemicals maker Lonza has said it's targeting pharma and biotech for growth, as companies increasingly farm out manufacturing. But so far, its pharma unit is suffering.
Swiss drug ingredient and chemical maker Lonza has reorganized its drug ingredient and custom pharma manufacturing units and is closing a U.S. plant to reduce costs, but so far the move has resulted in lower sales in pharma.
After months of regulatory woes and declining demand, Lonza is planning to cut two-thirds of its staff at a Massachusetts biologics plant, part of the CMO's overall effort to restructure and adapt to a changing market for commercial manufacturing.
Swiss contract manufacturer Lonza has been dealing with quality issues at its biologics plant in Hopkinton, MA, for a couple of years. And so in July, the company said it had decided to phase it out, eliminate 250 jobs and concentrate that work at a facility in Switzerland. The company says now most of those cuts will happen by the end of the year.
Lonza last month said it was going to phase out work at its troubled biologics plant in Hopkinton, MA, eventually cutting about 250 jobs. At the time it didn't put a timeframe on the moves, but it now says it is set to begin next month.
Lonza 's biologics plant in Hopkinton, MA, has been a headache for the Swiss contract manufacturer and its customers. The company has struggled to get it up to FDA expectations, creating supply issues for clients, leading it to phase the plant out.
A Lonza plant in the U.S. has been struggling for 18 months to get its manufacturing practices back up to FDA expectations. But the shortcomings are now leading to shortages for one of its key clients.
French drugmaker Ipsen says shortages of its orphan drug Increlex appear inevitable because of ongoing issues at Lonza plant in the U.S. The drug is used to treat a rare condition in children called IGF-1 deficiency, which results in them being very short for their age.
Late last month, Alexion Pharmaceuticals ($ALXN) assured investors it was on top of the issues with its pricey rare-disease drug Soliris. But the FDA report indicates that Alexion has had trouble figuring out the source of the contamination and so adequately attacking it.