Independent French drugmaker Servier has linked up with Yposkesi, a Contract Development & Manufacturing Organization (CDMO) to develop and GMP manufacture lentiviral vectors to support allogenic CAR-T cell technology development.
Cell-based gene therapies have shown promising results in treating hematological malignancies. So far, successful therapeutic results have mainly been obtained with autologous CAR-engineered products. This approach, where the patient’s cells are collected then used to manufacture a drug for themselves, is limited by the need for recurrent apheresis in the patient and time to manufacture a GMP compliant product. On the other hand, allogeneic therapies offer the opportunity to manufacture large batches of the drug product, thus making off-the-shelf treatments available for a large number of patients. However, the challenges of manufacturing the scale-up of allogenic CAR-T still lie ahead.
“We are pleased to collaborate with Yposkesi, whose ability to produce the highest quality of lentiviral vectors in the most robust and sustainable way is in line with the stringent requirements for the industrial production of allogenic CAR-T cell therapy,” said Pierre Venesque, executive vice president industry at Servier, adding: “Allogenic CAR-T cell therapy is a promising new technology with an amazing potential to treat cancer patients.”
Under the terms of the agreement, financial terms of which were not disclosed, Servier will have access to Yposkesi’s world-leading know-how and technology for manufacturing lentiviral vectors, as well as its analytical development and quality assessment resources and capacity. Yposkesi has proven expertise in lentivirus manufacturing with several dozen batches used in clinical trials both in Europe and the USA. Servier will draw benefit from this track record in its strategic program.
This partnership has the potential for a longer-term lentiviral vector provision agreement, as Servier progresses towards commercialization.
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