Ncardia launches Cellistic™, the only iPSC-based cell therapy process development and manufacturing partner, purpose-built to make large-scale allogeneic cell therapy production a reality today

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GOSSELIES, Belgium–(BUSINESS WIRE)–Ncardia has launched a new business, Cellistic™, to focus Ncardia’s induced pluripotent stem cell (iPSC) expertise in the cell therapy development and manufacturing sector. This strategy extends to Ncardia’s existing drug discovery solutions business and capitalizes on the company’s deep expertise in iPSC differentiation and expansion to focus dedicated resources and capabilities to meet the need growth of iPSC cell therapy solutions, including the development of robust cell-specific manufacturing platforms.

The development of cellular therapies derived from iPSCs offers the possibility of effective treatments for many diseases and to reduce the cost and complexity of current autologous cellular therapies. However, a number of challenges need to be addressed in order to fulfill the promise of large-scale allogeneic cell therapy. Creating an effective treatment requires not only in-depth knowledge of the targeted disease, but also an in-depth understanding of the processes needed to generate the most relevant cell type to treat the disease, and the expertise to adapt that process to clinically and commercially feasible volumes. These differentiation and expansion activities present unique challenges and require unique experience and skills that, until the launch of Cellistic™, were unavailable to therapeutic developers without significant investment in internal capabilities.

Cellistic™ consolidates an unparalleled depth of knowledge in human biology with scalable, industry-ready process science capabilities into a single company, bringing over 10 years of iPSC-based development expertise purpose-built to enable the industry to provide therapies to millions of patients around the world. Cellistic’s services are designed to address the significant unmet needs of allogeneic cell therapy therapeutic developers, including immediate access to a wide range of bioreactor-based differentiation and expansion protocols; comprehensive and scalable cGMP capability; analytical support; and clinical preparation support for global regulatory submissions. Cellistic™ integrates these offerings into comprehensive workflows based on proprietary cell-specific manufacturing platforms that will offer therapeutic developers support for IND filing and include GMP capability to commercialize iPSC therapies of the future.

“Patients and biopharmaceutical companies are looking for cell-based treatments more than ever – and for an ever-widening range of diseases,” says Stefan Braam, PhD, CEO and CSO of Ncardia. “What has impeded the continued evolution of cell therapies has been the reliance on slower and more expensive autologous approaches, one batch per patient, and limited scale manufacturing processes. For more than a decade , we are working to develop the large-scale allogeneic science, technology and manufacturing capabilities whose time has come.

Ncardia’s technology portfolio and expertise has been validated by experience collaborating and partnering in process development and scale with Bluerock Therapeutics and other companies.

“Producing predictably differentiated, characterized, and functional cells for large-scale allogeneic iPSC treatments requires the kind of developmental and production sensitivity that only comes from years of scientific and real-world expertise in process and production,” said Elena Matsa, PhD, Vice President of Cellular Technology. “Cellistic™ brings exactly this level of knowledge. We know how to manage cells, how to verify cell type and functionality, and how to manufacture safe and efficient end products at scale. Our proprietary manufacturing infrastructure has been developed and refined over more than a decade and is unique in the industry.

“For more than a decade, Ncardia has strategically invested in developing the expertise and technical know-how to enable large-scale production of allogeneic iPSC treatment modalities – well ahead of market demand” , says Andy Holt, Chief Commercial Officer. “Our long-standing commitment to this science is now being given the resources to advance clinical programs as patients and biopharmaceutical companies increasingly turn to cell therapies as the only modality with promise to treat many unresponsive disease states. to other therapies. We have grown in this opportunity since our inception. We believe the market is now not only ready for, but also in dire need of, our unique capabilities to advance cell therapy innovations for patients.

About Cellular

Launched in April 2022, Cellistic™ specializes in the process development and manufacturing of cell therapies based on human induced pluripotent stem cell (iPSC) technology. Its focus and expertise in reprogramming, differentiation, and development of iPSC expansion protocols positions the company as the partner of choice for innovative cell therapy developers to bring advanced new therapies to market. Leveraging over a decade of Ncardia scientific and engineering knowledge and experience, Cellistic™ has unique capabilities for designing and optimizing proprietary manufacturing platforms for iPSC-based cells that deliver large-scale quality products. For more information, visit www.cellistic.com.

About Ncardia

Ncardia is a leader in contract research, development and manufacturing of iPSC-based solutions for early and preclinical drug discovery. Its goal is to enable pharmaceutical and therapeutic companies to make more confident discovery and development decisions by integrating iPSC technologies into their screening processes. Ncardia’s capabilities include disease modeling, manufacturing, test development and high-throughput screening, particularly for cardiac and neurodegenerative diseases. Ncardia was founded in 2011 and is majority owned by KINICITI, a private equity-backed advanced therapies platform. For more information, visit www.ncardia.com.

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