On September 22, 2022 Emercell SAS (Emercell) and Cell-Easy SAS (Cell-Easy) reported the signing of a strategic agreement for the scale-up and manufacturing of Emercell’s lead product (Press release, EMERCell, SEP 22, 2022, View Source [SID1234621370]).
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Emercell has developed a platform technology to produce off-the-shelf natural killer (NK) cells. NK cells are highly potent immune effectors, used alone as monotherapy, or in combination with therapeutic antibodies, or are genetically engineered to produce Chimeric Antigen Receptor (CAR)-NK cells for the treatment of hematological malignancies and solid tumors. NK-001 is an optimized cell therapy product composed of highly activated and alloreactive allogeneic NK cells. Its patented manufacturing process allows a complete industrialization by using the same batch of NK cells for multiple patients.
Cell-Easy is an analytics-driven Contract Development and Manufacturing Organization (CDMO) specialized in the production of Gene-modified Cell and Cell Therapy products. Cell-Easy’s facilities are located in Toulouse including state-of-the-art controlled environment suites optimized for developing manufacturing and analytical processes, proceed to environmental and material Quality Control, and execute cGMP manufacturing, fill & finish, long-term storage of Advanced Therapy Medicinal Products (ATMPs) compliant with all the requirements of regulatory standards and cGMP guidelines.
Emercell has selected Cell-Easy as a long-term CDMO partner for the scale-up and manufacturing operations of its allogeneic NK cell-based product, with the objective to enter clinical phase in 2023. Emercell has signed a strategic agreement with Cell-Easy specialized in the development and production of ATMP.
"We are very pleased to collaborate with Cell-Easy on the final stages of development and GMP manufacturing of our flagship product, NK-001", said Patrick Henno, President of Emercell." We are looking forward to a successful and long-lasting collaboration as a key element of our development strategy. Moreover, Cell-Easy and Emercell are located in the Occitanic Region and the partnership fits perfectly with the Region’s objectives regarding the development and production of new products in the field of biotherapies, and particularly in the field of immunotherapy.
In a very competitive European landscape, we are delighted that Emercell has chosen us as their privileged CDMO Partner for their first immune-oncology approach using NK-cells", said Guillaume Costecalde, President of Cell-Easy. "Cell-Easy CDMAO’s original approach and the team’s reactivity combined with our state-of-the-art facility allow us once again to convince ambitious ATMP developers such as Emercell to secure their development."