SAN DIEGO, Feb. 3, 2016 /PRNewswire/ -- Invetech, a global leader in instrument development, custom automation and contract manufacturing, and Celyad SA, (CYAD.BR) ("Celyad"), a biopharmaceutical company focused on identification and development of specialized cell-based therapies with product candidates in oncology and cardiology, today announced that they have entered into an agreement under which Invetech will develop and supply manufacturing systems to support production needs for C-Cure®, Celyad's most advanced product candidate based on the cardiopoiesis technology platform. Under the terms of the agreement, Invetech will provide Celyad with a range of advanced design and manufacturing services to support development of customized manufacturing systems for commercial production of C-Cure®.
"Our feasibility study for automated manufacturing of C-Cure® delivered excellent results and provided strong support for the continued development of this promising automation platform. Importantly, this program also builds on and expands our expertise in core cell therapy development," said Dieter Hauwaerts, vice president, operations, Celyad.
In this collaboration, the system design and production teams at Invetech will supply Celyad with a modular, readily scalable and highly automated production suite able to facilitate simultaneous processing of multiple patient-specific therapies. The manufacturing system is designed to be rapidly expandable to accommodate anticipated increases in production volume to support future global commercialization pending regulatory approvals.
"We are pleased to be supporting Celyad in the translation of their exciting C-Cure® product from clinical trials to commercial production. Our experience with automating manual processes has enabled us to design a GMP compliant manufacturing system that meets Celyad's need for efficient manufacturing combined with patient safety," said Richard Grant, Global Vice President, Cell Therapy, at Invetech. "This agreement reflects Invetech's ability to adapt biopharmaceutical process design methodologies to address the unique demands and challenges presented by the cell therapy industry."
C-Cure® is Celyad's most advanced product candidate based on its cardiopoiesis platform and is being developed for heart failure indications. The Company expects to release the full clinical data set for CHART-1, its Phase III trial in Europe and Israel, in the middle of 2016. The research underlying this technology was originally conducted at Mayo Clinic by the research team of Professor André Terzic and Atta Behfar, and has been published in numerous peer-reviewed publications. C-Cure® consists of a patient's own cells harvested from bone marrow, treated with cardiopoietic growth factors and then re-injected into the heart. It is designed to produce new autologous heart muscle cells that behave identically to those lost as a result of infarction, without the risk of rejection. C-Cure®'s potential has been demonstrated in a multi-center randomized controlled Phase II trial conducted in Europe. Results of the C-Cure® Phase II trial were published in April 2013 in the Journal of American College of Cardiology.
Celyad, previously Cardio3 BioSciences, is a biopharmaceutical company focused on translating breakthrough cell-based research into innovative therapeutics to improve the outcome of severe diseases. The Company is currently developing clinical stage cell therapies in cardiology and oncology, two healthcare segments with high unmet medical needs.
Invetech has been creating breakthrough products and custom automation systems for more than 30 years. With experience drawn from more than 5000 projects globally, Invetech partners with global leaders in industry to deliver product design and development, contract manufacturing and custom automation services. The company has experience in a broad range of market sectors including cell therapy production automation systems, laboratory diagnostics, point of care diagnostics, life sciences, industrial and consumer products.
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