Early last year, Allogene entered into a lease to build a 118,000-square-foot cell therapy production plant in California. The plant is central to Allogene’s plan to make CAR-T therapies available on a far larger scale than happens today.
COVID-19 threatened to set back the construction project. AstraZeneca recently said it is too early to state the impact of the pandemic on the construction of its oft-delayed headquarters, but Allogene is more confident in its schedule.
“I am pleased to report that our build-out for our Newark manufacturing facility is continuing in full force. Thus far, we have experienced only minor delays as a result of the pandemic, and we remain on track to bring the manufacturing facility online in 2021,” said Allogene CFO Eric Schmidt on a call with investors to discuss second quarter results.
Allogene is building the plant to produce off-the-shelf CAR-T cell therapies. Down the line, Allogene envisages the plant making multiple commercial products and lessening its reliance on the contract manufacturing organization that supplies it with products today.
While some biotechs never build in-house capacity, Allogene, like many cell and gene therapy firms, sees the construction of its own facility as an important part of its strategy. The complexity of cell and gene therapy production and shortage of outsourced capacity is driving many companies to set up in-house manufacturing operations.
As a developer of allogeneic, not autologous, CAR-T therapies, Allogene is free from the logistical challenges associated with working with a patient’s own cells. However, allogeneic CAR-T therapies have their own challenges.
Allogene CEO David Chang, who worked on autologous cell therapies while at Kite Pharma, said the allogeneic manufacturing process is “a little bit more complicated.”
“We really break this down into how to develop the proper analytic assay so that we can continue to improve the manufacturing and certainly taking care of all the assays that are necessary to qualify the release material according to the regulation,” said Chang. “The other part is the things that are needed to ensure the manufacturing facility can pass any kind of preinspection.”
Chang acknowledged it may sound “a little bit premature” to be considering inspections when the site is still under construction. However, Allogene already has teams “thinking ahead in preparation of the BLA filing.”
The transition from the current outsourced facility to the new internal site is one potential stumbling block. Allogene has made plans for the transition and thinks it will only need to run analytic bridging studies to support the transition.
