Cellectis, the French clinical-stage biopharma business, has joined forces with Lonza in a manufacturing service agreement. The contract covers clinical manufacturing of Cellectis’ allogeneic UCART product candidates targeting haematological malignancies. The manufacturing will take place at Lonza’s GMP facility in Geleen, Netherlands.
Alberto Santagostino, Senior Vice President, Head of Cell & Gene Technologies, Lonza, explained: “We will draw on the experience at our cell and gene therapy centre of excellence in the Netherlands, ideally equipped to support Cellectis in bringing their promising pipeline of allogeneic CAR-T therapies to people around the world in need of life-saving products.”
As part of the agreement, Lonza is in charge of implementing Cellectis’ manufacturing processes as per current Good Manufacturing Practices (cGMP) in a way that meets the highest quality and safety standards outlined by the FDA.
“Working with Lonza increases our global capabilities and allows Cellectis to further strengthen its manufacturing expertise," said William Monteith, Executive President, Technical Operations at Cellectis. He added: "This agreement not only bolsters our product supply for clinical trials, but it ensures that we are producing first-rate product candidates so that we can potentially deliver new hope to patients living with certain blood cancers.”
The manufacturing process of Cellectis’ allogeneic CAR T-cell product line, Universal CARTs or UCARTs, yields frozen, off-the-shelf, non-alloreactive engineered CAR T-cells.
UCARTs are intended to be readily available CAR T-cells for a large patient population. Their production is industrialised with defined pharmaceutical release criteria.
Lonza’s supply will complement Cellectis’ ongoing collaboration and in-house manufacturing sites, IMPACT and SMART, which are currently under construction.