Point of Care Platform

Theracell Advanced Biotechnology, through its partnership with Orgenesis Inc. (NASDAQ: ORGS), a leading global biotech company focused on cell and gene therapies (CGTs), aims to establish point of care (“POCare”) centers at hospitals and medical institutions in Greece and in the region of South-East Europe. Theracell will actively participate in the clinical development of new therapies through to marketing authorization by the regulatory authorities.

The Orgenesis POCare platform offer cell and gene therapies in close proximity to medical centres with the goal of significantly improving the accessibility to advanced therapy medicinal products, by lowering the processing costs and eliminating the logistic and administrative challenges associated with centralized manufacturing of such therapies. Additionally, increased automation and utilization of proprietary technologies results in efficient and safe production of CGTs.

Laboratories

Theracell Laboratories, the new business entity created, representing the Joined Venture, plans to deploy Orgenesis Mobile Processing Units and Labs (“OMPULs”) at leading hospitals for the onsite development of innovative treatments. OMPULs are multi-purpose, mobile, autonomous good manufacturing practice (GMP) facilities used to develop, optimize, and process cell and gene therapies near the clinical setting of application.

Orgenesis possesses a rich, expanding and diverse therapeutic pipeline, spanning the areas of Immuno-Oncology, Viral Infections, Metabolic and Autoimmune Diseases, Vascular and Musculoskeletal diseases and Kidney Disease. These therapies will be brought to the Market through the global network.

Technologies and Automations

Theracell Laboratories invests heavily in new technologies that will allow implementation of its therapeutic protocols at low cost and minimized logistic manipulation of patient samples. Our aim is to set up an efficient Point of Care network that will deliver our therapies under GMP conditions close to the patient.

Automation and processing of samples in closed culture systems and bio-isolators will limit human intervention and allow reproducible and safe scale-up and production process of the highest standards. The cells processed in closed systems will be constantly monitored to ensure they are delivered to the patients at the highest possible quality and metabolic activity.

The notion of delivering treatments close to patients ensures minimum manipulation of cellular therapy products and quick processing and availability.