Lonza will construct suites at its site in The Netherlands dedicated to producing Phase III and commercial supply of Gamida’s bone marrow transplant cell therapy omidubicel.
Lonza has produced clinical supply of omidubicel for Gamida but the strategic deal announced today will see the Swiss contract development and manufacturing organization (CDMO) fulfil the future commercial supply from its site in Geleen, The Netherlands.
Formerly known as NiCord, omidubicel is the Massachusetts-based cell therapy firm’s lead candidate, currently in Phase III trials as a hematopoietic stem cell transplantation (HSCT) – or bone marrow transplant.
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The candidate is the first such therapy to receive US Food and Drug Administration (FDA) Breakthrough Therapy Designation. It is comprised of immune cells, along with umbilical cord blood expanded through Gamida’s nicotinamide-based technology platform, which allows the cells to grow while maintaining stem-like functionality.
Alberto Santagostino, head of cell and gene technologies at Lonza Pharma & Biotech, did not divulge financial terms of the deal but old Bioprocess Insider his firm is constructing dedicated suites as part of the business model the CDMO has with Gamida.
“We offer different solutions ranging from use of multi-customer/product facilities to dedicated assets depending on the individual customer’s need. As we are providing Gamida with capacity for phase III and potentially commercial supply, the dedicated suites give them full flexibility for supply with the ability to ramp up production up as needed.”
Each Suite will be equipped with three workstations, he continued, adding “a ramp up plan has been agreed upon to increase the number of suites as needed to meet market demand.”
Going Dutch
Lonza added the Geleen site to its cell and gene therapy network through the acquisition of PharmaCell in 2017. At the time, the CDMO said the site had more than 6,000 m2 of GMP clean rooms, QC and other support spaces. PharmaCell also had a second site in The Netherlands, which according to Santagostino is also now fully integrated into Lonza’s cell and gene therapy network.
“The integration was very efficient, a testimony to the dynamic team we have there,” he told us. “The two sites in the Netherlands – Maastricht and Geleen – form our European center of excellence for cell and gene. We provide clinical and commercial manufacturing as well as development services.”
The sites in The Netherlands already have experience with commercial products, Santagostino added.