Swiss CDMO leader Lonza has had its cell therapy facility in the U.S. slapped with a warning letter after halting some production there two months ago because of sterility problems with a product it was producing for a client.
The company acknowledged the FDA action in its first-quarter earnings report Tuesday, saying that the warning letter was issued Monday for its facility in Walkersville, Maryland. The FDA had concerns about issues including validation and aseptic process simulations, the drugmaker said.
“Lonza takes this issue seriously, and has already started to address all issues raised by the FDA,” the company said.
Lonza first learned about the issue in December after “product end-user notified the FDA of the issue,” Lonza spokeswoman Constance Ward said in an email Tuesday. Lonza opened an investigation after confirming the sterility issue. She said the plant halted production of the product in the affected manufacturing area in early February, while also quarantining the inventory it had on hand.
"After inspecting both the customer of the product and the Walkerville operations, the FDA issued Lonza a warning letter that identified issues involving validation, aseptic process simulations, corrective and preventive actions, and environmental monitoring,” Ward explained.
She said the company expects to have the problems resolved and FFM media manufacturing back online by mid-2017. The company had already begun a $7.6 million manufacturing upgrade at the facility, which Ward said is slated to be finished in 2018.
While the drugmaker said it expects the latest FDA action to have “minimal” impact on revenues of its Pharma & Biotech segment, it reported sales in the segment were softer in the first quarter because of the action. Without providing specific numbers, the contract manufacturer Tuesday reported that growth in that segment was driven by demand in mammalian manufacturing, as well as in clinical development and licensing.
This is not the first time that Lonza has faced FDA concerns about its biologics operations in the U.S. An API plant it had in Hopkinton, Massachusetts, was cited in 2011 over a plethora of problems, creating supply problems for a drug it manufactured there at the time for French drugmaker Ipsen. After struggling to get issues resolved, Lonza simply closed the plant and concentrated its biologics work at its extensive site in Visp, Switzerland.
Lonza is preparing to expand its Visp biologics capability further. It will break ground in the second half of the year on a new large-scale biologics production facility that it is building in partnership with France’s Sanofi. The companies announced in February that they would share the cost, and capacity, of a €270 million ($286.3 million) plant at Lonza’s site in Visp.