Under the terms of the agreement, PharmaCell will perform a technology transfer from its US-based contract manufacturing partner to its newly acquired Geleen facility in the Netherlands to support the clinical trial with ICT-107. The deal is the first sign that PharmaCell is filling capacity at the cell therapy production facility, which was purchased from TiGenix last year, and which currently is used to manufacture TiGenix’s ChondroCelect, a product for cartilage repair.
Alexander Vos, CEO of PharmaCell, told Outsourcing-Pharma.com: “PharmaCell has experience in the field of producing dendritic cell-based vaccines due to its long-term relationship with Dendreon,” which it worked with since 2011. Denderon is now bankrupt.
“Our sites in Maastricht and Geleen are both fully licensed for the commercial production of cell-based therapeutics in the European Union. The size of our facility in Geleen, with 45,000 square feet, enables us to offer customers the opportunity to expand to the volumes required for commercial scale production,” he added.
He also said that the new work “confirms that our new Geleen facility is indeed viewed by industry experts as meeting the requirements and client expectations for late clinical stage and commercial manufacturing for ATMPs [Advanced-therapy medicinal products].”
Both of the company’s manufacturing sites are GMP-licensed and inspected by EMA for commercial production of ATMPs (Advanced Therapy Medicinal Products).