Lonza Expands in US, Moves Some Production
06.03.2018 -
Swiss fine chemicals producer and pharmaceutical industry supplier Lonza is expanding one production facility in the US while downsizing another.
The company said earlier the expansion of its late-stage clinical and commercial encapsulation capabilities for solid oral and inhaled dosage forms at Tampa, Florida, was due to be completed by the end of February.
In Walkersville, Maryland, Lonza plans to move cell-therapy work out of facility that reports said received an FDA warning letter last year. Company officials told local media, however, that some of the employees may be retained as it expands other work.
Among investments at the Florida site, the Swiss company planned to add a new Harro Hӧfliger Modu-C MS encapsulation unit in a move to improve speed-to-market capabilities. The specialized drum-dosing technology is used for powder-in-capsule (PIC) filling for oral solid dosage forms including dry powder inhaler (DPI) applications.
Lonza said the investment strengthens its full-service product-development capabilities and capacity to support process development, clinical trial and commercial scale manufacturing utilizing encapsulation while also complementing its participation in PIC studies based on the company’s Xcelodose Precision Powder Micro-Dosing Systems. The Tampa site already has Xcelodose capacity.
By May of this year, the company expects to complete a new dispensing area and two new processing suites at Tampa, broadening capabilities for the handling of highly potent active pharmaceutical ingredients (HPAPIs). Finally, a new suite will also be added that facilitates encapsulation of highly potent compounds.
In future, Lonza wants to concentrate its gene and cell therapy work at centers of excellence. Sites in Pearland, Texas, USA, and Geleen/Maastricht, the Netherlands, would handle process and analytical development, as well as clinical and commercial supply, while sites in Portsmouth, New Hampshire, USA, and Singapore would handle clinical and commercial manufacturing.
At Walkersville, the Basel-based firm plans to concentrate on bioscience solutions work, providing custom and off-the-shelf media solutions. The FDA issued a warning letter for the plant last year after Lonza was forced to halt some production because of sterility problems with a cell therapy product it was producing for a client. The company said it first learned about the issue after a product end-user notified the FDA of the issue.