Even as CDMO Lonza deals with FDA concerns about its cell manufacturing operation in the U.S., it has gone out and acquired a gene and cell contract manufacturer in Europe.
Lonza said last week that it had acquired Netherlands-based PharmaCell for an undisclosed sum. It said the company had revenues of about €11 million last year. The company has a 15,500 cell manufacturing facility in Maastricht, The Netherlands, which can produce clinical through commercial-scale product.
Lonza said PharmaCell was primarily selected because of its expertise in autologous cell and gene therapy manufacturing, which includes experience with two licensed products in Europe.
"PharmaCell’s position in the market complements Lonza’s leadership position in the allogeneic cell manufacturing market," Andreas Weiler, head of emerging technologies at Lonza said in a statement.
Autologous therapies use a patient’s own cells to create custom products as opposed to allogeneic therapies which can be manufactured in large batches from unrelated donor tissues such as bone marrow which can be used in “off-the-shelf” therapies.
Loza said with this deal its gene therapy manufacturing network will span Europe, Asia and the U.S. It is Lonza’s U.S. operation in the U.S. that recently ran into FDA concerns. Lonza had its cell therapy facility in Walkersville, Maryland, slapped with a warning letter in April after earlier halting some production of liquid media products being produced for a client.
The plant is overseen by the FDA’s devices unit because its products are used for diagnostics. The letter said that retained samples were found to have Pantoea organisms that Lonza discovered after receiving two confirmed complaints for sterility failures of a of product.
A spokesperson said when the warning letter was issued that 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 is slated to be finished in 2018.