On August 20, 2026 BioOra Limited reported a commercial manufacturing supply agreement with Miltenyi Biotec, a global leader innovating technologies and services for patient-specific cell and gene therapies. Under the agreement, Miltenyi Biotec’s CDMO division, Miltenyi Bioindustry, will provide commercial manufacturing and supply of lentiviral vectors for atlacabtagene autoleucel (Atla-cel), BioOra’s lead CD19-directed CAR T cell therapy. The agreement builds on a long-standing relationship between the two companies and supports the therapy’s continued development and potential commercialization.
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Atla-cel, currently in Phase II clinical development, is a third-generation autologous CD19-targeted CAR T therapy being developed for patients with B-cell non-Hodgkin lymphoma and other B-cell malignancies. Originating from research at the Malaghan Institute of Medical Research, the therapy has generated encouraging early clinical results and is advancing into registration-directed clinical development. John Robson, our Managing Director at BioOra, said:"BioOra was established to expand patient access to CAR T therapies through a scalable manufacturing approach. Partnering with Miltenyi Biotec strengthens our ability to deliver novel therapies such as Atla-cel to patients while supporting our long-term vision of building a globally relevant cell therapy manufacturing ecosystem from New Zealand."
Miltenyi Biotec will produce the lentiviral vectors for Atla-cel at its FDA-approved facility in Gaithersburg, Maryland. Since receiving approval in 2024, the site has delivered more than 500 GMP batches at 50L and 200L scale, supporting more than 100 clinical trials across 28 countries. "As Atla-cel advances toward pivotal development, we are pleased to contribute the expertise, quality standards, and supply reliability needed to help bring innovative therapies to patients," said Boris Stoffel, Managing Director of Miltenyi Biotec.
About Atla-cel
Atla-cel is a third-generation autologous CD19-targeted CAR T cell therapy being developed for the treatment of B-cell malignancies, including B-cell non-Hodgkin lymphoma. Developed initially by the Malaghan Institute of Medical Research and commercialized through BioOra, Atla-cel is designed to combine potent anti-tumor activity with an improved tolerability profile while enabling more efficient manufacturing and delivery of therapy. The program has completed initial clinical evaluation and is advancing through registration-directed development.
(Press release, BioOra, AUG 20, 2026, https://bioora.com/our-stories/miltenyi-biotec-to-support-commercial-manufacturing-of-biooras-cd19-car-t-therapy-candidate-atla-celnbsp [SID1234670249])