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The companies have signed a strategic multi-year manufacturing agreement for the future commercial production a late-phase investigational cell therapy.
On June 19, 2019, Lonza and Gamida Cell, a clinical-stage biopharmaceutical company specializing in cellular and immune therapeutics, announced that they have entered into a strategic multi-year manufacturing agreement under which Lonza will supply future commercial production of omidubicel, Gamida Cell’s investigational advanced cell therapy, upon potential approval by FDA.
Under the agreement, Lonza will construct and dedicate production suites at its Geleen, Netherlands site for the anticipated commercial launch. The agreement also enables Gamida Cell to increase the number of dedicated production suites over time to ensure commercial supply and gives the company the option of expanding further into Lonza's global cell and gene therapy manufacturing network.
This agreement follows an earlier multi-year clinical manufacturing relationship between the two companies and provides Gamida Cell with a path to commercial supply of omidubicel. The product is currently in Phase III clinical development for enhancing the benefits of hematopoietic stem-cell (bone marrow) transplant.
“This agreement is an example of our long-term manufacturing partnership capabilities and efforts to drive the industrialization of the cell therapy industry. Our cell therapy experience and expertise will enable us to best support Gamida Cell at this important phase in the development of omidubicel. [We] look forward to enabling Gamida Cell to deliver omidubicel at a commercial scale after potential FDA approval,” said Alberto Santagostino, senior vice-president, head of Cell & Gene Technologies, Lonza Pharma & Biotech, in a company press release.
“Gamida Cell and Lonza have had a strong relationship for the clinical supply of omidubicel, and we are pleased to extend our relationship as we prepare to potentially bring omidubicel to patients in a commercial setting after potential FDA approval. The ability to reliably provide an advanced cellular therapy to patients is critical, and this agreement provides Gamida Cell with access to a top-tier manufacturing site for the long-term commercial supply of omidubicel after potential FDA approval. Additionally, this agreement enables the supply of commercial product as we plan for the build-out of Gamida Cell’s own commercial-scale cGMP manufacturing facility to augment production,” added Julian Adams, CEO of Gamida Cell, in the press release.