Mustang Bio has opened a CAR-T cell manufacturing facility in Massachusetts it says has capacity to treat up to 800 patients annually.
Fortress Biotech-owned Mustang has several chimeric antigen receptor T cell therapies in its pipeline and has opened a facility in Worcester, Massachusetts to support their development.
“Total investment into the facility, including the build out and equipment was between US$5 million (€4.3 million) and $7 million,” Mustang Bio’s chief technology officer Knut Niss told BioProcess Insider.
The current space comprises of four cleanrooms totaling 14,000 square-feet of clinical manufacturing capacity.
“We anticipate that the capacity at the current build will be between 500-800 patients per year,” he said, adding an additional 13,000 square-feet expansion is planned as Mustang looks to feed future market needs.
Mustang has 20 full-time employees but is looking to add a further 10 over the next few months.
In-House vs Outsourcing
Niss described Mustang’s CAR-T manufacturing process:
“We isolate the T-cells from a patient’s apheresis product, followed by a lentiviral transduction to introduce the CART construct into these cells. After an additional expansion, cells are formulated to the product and deep frozen.”
The two US Food and Drug Administration (FDA) approved CAR-T therapies, Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel), are both produced in-house by their respective drugmakers, Novartis and Gilead/Kite.
According to KNect365 Life Sciences’ recent state of the industry report, a lack of specialized contract manufacturing organization (CMO) capacity and a penchant for keeping greater control over newer, more-complex production methods, has led to manufacturers choosing to invest in their own manufacturing capabilities.
“We did a comprehensive business modelling where we compared the cost of contracting vs. making our own. We concluded that with multiple assets the make your own model is favored,” said Niss. “In addition, we determined that controlling the capacity will be a significant competitive advantage.”