RoslinCT and Ayrmid Ltd. Announce Expansion of Strategic Partnership to Manufacture Omisirge® (omidubicel-onlv) for Second FDA-Approved Indication in Severe Aplastic Anemia (SAA)
RoslinCT is performing technology transfer and will support commercial manufacture of Omisirge® for an additional indication following successful clinical trialsOmisirge® now FDA-approved for an expanded patient population in hematologyRoslinCT continues to support and advance multiple cell therapy projects at its Hopkinton, MA facility
Ayrmid Ltd., the parent company of Gamida Cell Inc., a pioneering cell therapy company transforming cells into powerful therapeutics, and RoslinCT, a global leader in cell and gene therapy contract development and manufacturing, today announced the expansion of their strategic partnership to include the execution of a commercial supply agreement to support production of Omisirge® (omidubicel-onlv).
Following positive clinical trial results, Omisirge® has received FDA approval for a second indication, broadening its use in the treatment of hematology patients. Under the commercial supply agreement, RoslinCT will complete technology transfer and support commercial manufacturing of Omisirge® for this additional indication at its state-of-the-art cGMP cell therapy manufacturing facility in Hopkinton, MA.
“We are excited to expand our collaboration with RoslinCT to add US manufacturing as Omisirge® moves into its next phase with the recent FDA approval for patients suffering from severe aplastic anemia,” said Dr Joe Wiley, Chairman and Chief Executive Officer of Ayrmid Ltd. “This important strategic partnership enhances our dual sourcing approach and secures patient supply in the longer term.”
“The expansion of Omisirge®’s commercial manufacturing at RoslinCT demonstrates the strength of our partnership and the capability of our facilities to support innovative therapies at scale,” said Peter Coleman, Chief Executive Officer of RoslinCT. “Alongside Omisirge®, we continue to progress multiple cell therapy projects, reflecting our commitment to enabling transformative treatments for patients worldwide.”
About Omisirge®
Omisirge® is a nicotinamide-modified allogeneic hematopoietic progenitor cell therapy derived from the youngest donor source, designed for ease of infusion. The product is FDA-approved and commercialized for patients with hematologic malignancies. With the new indication, Omisirge® now provides treatment options for a broader patient population, enhancing its potential to improve outcomes.
About RoslinCT
RoslinCT is a leading global contract development and manufacturing services organization (CDMO) focused on Advanced Cell and Gene Therapies. Established in 2005 and built upon the ground-breaking technology cloning of Dolly the Sheep at the Roslin Institute in 1996, RoslinCT has harnessed cutting-edge science to advance the development of human medicines. With a remarkable heritage in the field, the company has achieved significant milestones. These include being among one of the first in the world to produce clinical-grade human pluripotent stem cells. In collaboration with the partners, RoslinCT also developed the first CRISPR-edited cell therapy product for a major inherited disorder, taking it from early development to commercialization.
Equipped with 22 purpose-built cGMP cell therapy processing suites in Edinburgh, Scotland, and Hopkinton, Massachusetts, RoslinCT provides innovative process and analytical development, cGMP clinical and commercial manufacturing for a range of cell types for both autologous and allogeneic processes, and cGMP iPSC cell line development, gene editing, and differentiation.
With tailored CDMO solutions, RoslinCT enables partners to efficiently progress from development to commercialisation and deliver life-saving Cell and Gene Therapies worldwide. RoslinCT is a GHO Capital portfolio company. Discover more about our services at www.roslinct.com.
About Ayrmid Ltd. and Gamida Cell
Ayrmid Ltd. is the parent company of Gamida Cell Inc., a pioneering cell therapy company developing novel treatments designed to turn cells into powerful therapeutics. Gamida Cell Inc. currently has two FDA approved products on the market in the US, namely Omisirge (please see the current full Prescribing Information, including boxed warning, here) and APHEXDA® (please see the current full Prescribing Information here). Gamida Cell operates as a wholly owned subsidiary of Ayrmid Limited, a UK entity. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, X, Facebook or Instagram.
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