The Swiss contract manufacturing firm announced the warning letter today in a filing on the SIX exchange, explaining it “takes this issue seriously, and has already started to address all issues raised by the FDA.”
A spokeswoman told us "Manufacturing in the impacted area had already been voluntarily suspended while corrective actions are being executed to rectify the issue. Manufacturing in that area may be able to resume in mid-2017, once the essential elements of the comprehensive corrective action plan are completed."
Complaint
The inspection was triggered by a customer complaint about its For Further Manufacturing (FFM) media, which is used in a variety of applications including drug and vaccine development and cell therapy production.
The spokeswoman told us "On 16 December 2016, Lonza was contacted about a product quality complaint relating to a custom-made product made for a specific customer. A product end-user notified the FDA of the issue when it was detected. As soon as the sterility issue was confirmed, Lonza Walkersville opened an investigation.
"As of 2 February 2017, all production of the impacted FFM Media in the affected manufacturing area was halted and Walkersville’s existing inventory of these products was placed in quarantine" she continued, adding that "FDA concurrently inspected both Lonza Walkersville and the customer of the impacted product. The FDA’s inspection of Lonza Walkersville concluded in early February."
Bioscience impact
Lonza said the problems had impacted its bioscience solutions business in the first quarter, describing the unit's performance as "slightly softer due to quality issues at our Walkersville, MD (USA) facility"
However, the firm went on to say it does not expect the Walkersville site issue to have a significant impact on its wider Pharma&Biotech Segment in the rest of the year.
Walkersville
The Walkersville site provides a range of services as part of Lonza's bioscience solutions business.
For example, in February, it was named as the production base for Phase III trial supplies of TiGenix’s allogeneic stem-cell candidate Cx601.
The plant also makes a reformulated CHO media that was launched last March.
Increases sales forecast
In other news, Lonza also announced it was upping its sales forecast for the year citing an “outstanding first quarter.”
While it did not disclose figures, Lonza said it now expects sales to grow in the high-single digits, up from the mid-single digit growth it had previously forecast.
The firm cited its recent deal with Sanofi and the impending completion of its takeover of Capsugel as likely drivers.