Just thought I'd share this since this any further manufacturing agreement with Lonza will limit what sites Mesoblast could produce its product due to a warning letter (Form 483) from the FDA in 2018. It looks like Lonza has resolved these issues since and therefore increases the likelihood the FDA will have no problem with the manufacturing site in Singapore when they do their inspections.


https://www.fiercepharma.com/manufacturing/lonza-cuts-125-jobs-as-it-moves-cell-work-from-u-s-plant-hit-warning-letter

Lonza cuts 125 jobs as it moves cell work from U.S. plant hit with warning letter

by Eric Palmer |Mar 5, 2018 10:57am

The decision by Swiss drugmaker Lonza to move cell-therapy work out of a U.S. facility that was hit by an FDA warning letter last year will cost the plant about 125 jobs.

The CDMO recently said that it would concentrate its gene and cell therapy work at "centers of excellence." Its sites in Pearland, Texas, and Geleen/Maastricht in the Netherlands will handle process and analytical development, as well as clinical and commercial supply, while sites in Portsmouth, New Hampshire and Singapore will do clinical and commercial manufacturing sites.

As a result, cell therapy work is being moved out of its site in Walkersville, Maryland, which was cited by the FDA last year. The Maryland site will concentrate on its bioscience solutions work providing custom and off-the-shelf media solutions.

The warning letter was issued last year after Lonza halted some production because of sterility problems with a cell therapy product it was producing for a client. Lonza first learned about the issue after “product end-user notified the FDA of the issue,” Lonza spokeswoman Constance Ward said at the time. The FDA warning letter uncovered issues that included with validation and aseptic process simulations.

Lonza some years back ran into FDA concerns about its biologics operations at an API plant it had in Hopkinton, Massachusetts, which was cited in 2011 for a plethora of problems. The action created supply problems for a drug it manufactured there for French drugmaker Ipsen.

After struggling to get issues resolved, Lonza simply closed the plant, eliminated 250 jobs, and concentrated its biologics work at its extensive site in Visp, Switzerland.