- A subsidiary of contract drugs manufacturer Lonza will produce TxCell's CAR-Treg product TX200, in development for the prevention of chronic rejection after organ transplant, under a new deal announced May 31.
- TxCell finalized its CAR-Treg manufacturing process in February 2018 and began the transfer over to Lonza that same month. The transfer is expected to complete in the first quarter of 2019.
- Lonza will manufacture TX200 at its production site in Geleen, the Netherlands, from which it can be shipped frozen to clinical sites across the U.S. and Europe. The experimental therapy is in preclinical development, and TxCell has plans to submit a clinical trial authorization application planned for early 2019.
The growing pipeline of CAR-T cell therapies, both on the market and in development, is creating supply chain challenges. This is particularly true for autologous therapies, which are based on a patient's own cells.
While TX200 is based on donor cells, there are still challenges in the production and supply process, from isolating the starting regulatory T cell (Tregs) subset, creating the engineered antigen-specific Tregs and then transporting the cells to their final location. One of the benefits for TX200, according to TxCell, is that it can be both frozen and thawed with no change in cellular phenotype and function.
Due to this this complexity, TxCell has chosen to outsource the manufacturing process to Lonza.
"Lonza's skill and know-how will provide the support and expertise necessary to develop our lead CAR-Treg program, which is on track to enter the clinic," said Stéphane Boissel, CEO of TxCell.
For its part, Lonza has been busy expanding its own capacity, recently opening a 300,000-square-foot plant in Pearland, Texas, that the company believes is the world's largest dedicated cell and gene therapy production site.
Other companies are building up their own in-house capacity. For example, Gilead Sciences recently leased a 120,000-square-foot site in the Netherlands to support manufacture of Yescarta (axicabtagene ciloleucel).