Dive Brief:
- Swiss drug manufacturer Lonza Ltd. on Tuesday officially opened the doors to its newest facility, a 300,000-square-foot plant that by its measure is the world's largest site dedicated to the production of cell and gene therapies.
- The facility, located outside of Houston in Pearland, Texas, is indicative of Lonza's confidence that cell and gene therapies represent the future of biomedicine for dozens of genetic or rare diseases.
- By year end, Lonza plans to employ 200 staff at the site, which already has begun manufacturing product for several biopharma customers.
Dive Insight:
After decades of halting progress, gene therapy has made rapid strides in recent years. Two CAR-T cell therapies, which involve genetically engineering patient T cells to target cancer, are now approved in the U.S., as is the first gene therapy for an inherited disease.
And a pipeline of experimental therapies in hemophilia, eye conditions and other rare diseases is progressing behind those frontrunners.
Beyond the clinical challenges of designing a safe and effective gene therapy, however, such treatments involve complex manufacturing which poses operational challenges as the field advances. A shortage of the viral vectors used to deliver functional genes into humans, for example, raises the costs of goods and has sent drugmakers scrambling to secure their own supply.
In constructing its site in Texas, Lonza is counting on this demand to push drugmakers towards its contract business. The facility will support manufacturing from preclinical through commercial stages, and Lonza boasts the site will have capacity to produce treatments for thousands of patients.
Bluebird bio Inc., a gene and cell therapy developer, already contracts with Lonza's Texas unit for supply of drug product for its experimental Lenti-D, LentiGlobin and bb21217 therapies.
Lonza, however, isn't the only company betting on a greater need for gene therapy production capacity. Novartis AG's $8.7 billion takeover of AveXis Inc., for example, was motivated in part by the U.S. biotech's manufacturing facility and viral vector platform.
Smaller competitors like Brammer Bio LLC and Oxford BioMedica plc have also expanded in recent years.
But the size of Lonza's investment, added to its scope as a global contracting giant, will likely make it a dominant force.