France-based CellProthera chose CELLforCURE by SEQENS as its CDMO partner for a planned Phase III trial. The trial will evaluate ProtheraCytes®, an autologous expanded CD34+ stem cell-based therapy aimed at improving heart failure event-free survival following a severe heart attack. CellProthera will tech transfer to CELLforCURE by SEQENS this year, with plans to produce clinical batches starting in 2026.
Last year, CellProthera presented its Phase III design to FDA and received favorable advice. Tech transfer and qualification of the bioproduction process in a specialized facility capable of releasing clinical batches of cellular products is an essential prerequisite for the start of Phase III.
“Having a partner with expertise in advanced stage of clinical development and commercialization of cell and gene therapies adds substantial value for CellProthera as we enter the final phase of development for ProtheraCytes, looking at Phase III and through to market authorization,” said Matthieu De Kalbermatten, CEO of CellProthera.
“We selected CELLforCURE by SEQENS for the quality of its infrastructure, its equipment and the expertise of its team, which has already demonstrated its ability to release commercial batches of autologous therapies,” noted Jean-Olivier Hirsch, COO and qualified person of CellProthera.
“Our ability to embrace innovative technologies and scale up production for late-stage clinical trials will help accelerate the investigation of potential new therapies,” added Marc-Olivier Mignon, president of CELLforCURE by SEQENS.
The post CellProthera Selects CELLforCURE by SEQENS for Phase III GMP Manufacturing appeared first on GEN - Genetic Engineering and Biotechnology News.
Last year, CellProthera presented its Phase III design to FDA and received favorable advice. Tech transfer and qualification of the bioproduction process in a specialized facility capable of releasing clinical batches of cellular products is an essential prerequisite for the start of Phase III.
“Having a partner with expertise in advanced stage of clinical development and commercialization of cell and gene therapies adds substantial value for CellProthera as we enter the final phase of development for ProtheraCytes, looking at Phase III and through to market authorization,” said Matthieu De Kalbermatten, CEO of CellProthera.
“We selected CELLforCURE by SEQENS for the quality of its infrastructure, its equipment and the expertise of its team, which has already demonstrated its ability to release commercial batches of autologous therapies,” noted Jean-Olivier Hirsch, COO and qualified person of CellProthera.
“Our ability to embrace innovative technologies and scale up production for late-stage clinical trials will help accelerate the investigation of potential new therapies,” added Marc-Olivier Mignon, president of CELLforCURE by SEQENS.
The post CellProthera Selects CELLforCURE by SEQENS for Phase III GMP Manufacturing appeared first on GEN - Genetic Engineering and Biotechnology News.