A new Swiss production line where contract drugmaker Lonza is making active ingredients for Moderna's COVID-19 vaccine is still awaiting a regulator's licence necessary before the ingredients can be used.
Lonza said this week it had begun manufacturing drug ingredients at the production line, one of three being erected in Visp, Switzerland, and expects its first batch this month.
The Swiss company can produce and ship the drug ingredients before Swiss drugs regulator Swissmedic grants the facility a licence, but they cannot be released for use before Swissmedic approval, a Lonza spokeswoman said on Thursday.
Lonza is anticipating a visit from inspectors shortly. Swissmedic did not immediately comment.
"Our teams are working round the clock to deliver the drug substance for the Moderna COVID-19 vaccine and we are on track," Lonza said in a statement.
Moderna did not immediately comment on how the timing of the first batch of ingredients, or the outstanding Swissmedic license, could impact its delivery schedule, instead referring comment to Lonza.
After completion of the first Swiss production line, Lonza is preparing for two additional Visp lines to be commissioned.
The lines, which cost 70 million Swiss francs ($79 million) to build and require 60-70 employees each, will have capacity to produce ingredients for 300 million doses of Moderna's mRNA vaccine annually, Lonza has said.
From Lonza, the ingredients will be shipped to Laboratorios Farmaceuticos ROVI in Madrid for final filling, before delivery to European Union countries, Canada and elsewhere.
Moderna has targeted production of at least 600 million doses of vaccine in 2021, from Lonza-made ingredients as well as those from other facilities.
Lonza has a separate U.S. production line in Portsmouth, New Hampshire, that has begun producing ingredients for U.S.-bound Moderna vaccine.
It can produce ingredients for about 100 million doses annually, bringing Lonza's capacity to 400 million doses once all plants are running.
The Swiss company already has Swissmedic approval for a smaller facility in Visp where it has been making limited amounts of Moderna vaccine ingredients since last year.
($1 = 0.8871 Swiss francs)
(Reporting by John Miller; Editing by Jan Harvey)
