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Our Proprietary C3A Cell Bank

Our Proprietary C3A Cell Bank

The key to the performance of ELAD is our proprietary C3A cell bank. Our C3A cells are distinct from publicly available C3A cells and have been optimized for ELAD therapy. These cells are immortal, mimic certain functions of human liver cells and have been shown to retain many of the specific metabolic processes and pathways of hepatocytes. These functions include an active P450 enzyme system as well as the production of liver specific-proteins such as albumin, anti-thrombin III, alpha-fetoprotein, C3 complement, Factor V, transferrin, alpha-1-antichymotrypsin and alpha-1-antitrypsin.

The C3A cell line has been studied by independent investigators who have confirmed many of its hepatocyte properties, such as the presence of a functional cytochrome P450 toxin-processing enzyme system and the production of many liver-specific proteins. However, the C3A cell line does not entirely mimic the behavior of primary hepatocytes. For instance, it does not process ammonia as well as primary hepatocytes do and C3A produces large amounts of alpha-fetoprotein, or AFP, a non-toxic fetal analogue of albumin. We do not believe that these differences are clinically meaningful as they are not expected to impact the expected safety and effectiveness of the ELAD treatment and are clinically manageable.

We have customized the now-publicly available C3A cell line to create a proprietary C3A cell bank for use in ELAD, which we culture and expand through proprietary techniques. This cell bank represents a well-characterized stock of original cells that have been subjected to appropriate testing for viruses, pathogens and other contaminants in order to allow them to be used in humans. This bank contains enough cells to enable our clinical development and commercialization. VTI owns this C3A cell bank exclusively and on a royalty-free basis. In addition, we have developed proprietary methods for growing, storing and optimizing the function of these cells.

ELAD therapy is not patient specific and our C3A cell line derived from a single source is used to treat all patients. In contrast, autologous cellular therapy uses a patient’s own cells, which are manipulated in individual production batches, and is a costly and complex process. As a result, the production and logistics of treatment with our C3A cells does not face the challenges commonly associated with autologous cellular therapies.  

Our proprietary C3A cell bank is stored in three separate locations around the world for security purposes and is used as the basis for growing approximately one pound of cells needed for each patient at our production facility in Shandong Jinan High-tech Zone.