Genitope

Manufacturing

At Genitope Corporation, we have developed a proprietary manufacturing process which includes our Hi-GET® technology for gene amplification that is designed to enable the commercial development of personalized active immunotherapies. Our manufacturing process is divided into three phases: molecular biology, cell culture and production. The manufacturing of each patient's idiotype immunotherapy begins with the collection of a tumor sample from the patient. The patient's treating physician collects this tumor sample by a routine biopsy. The tumor sample is then shipped via an overnight courier to our manufacturing facility. After processing, each patient's idiotype immunotherapy is shipped back to the treating physician to administer the patient's course of immunizations.

Molecular Biology Phase

Upon arrival of the tumor sample at our manufacturing facility, cellular genetic material is extracted from the tumor sample, and the genes that encode the two unique regions of a patient's idiotype antibody are isolated. Our proprietary methods allow us to identify the genes encoding the tumor idiotype generally within a few weeks. Once identified, each of the two unique genes is inserted into an expression vector that contains all of the elements required for the production of a tumor-idiotype protein in a host cell.

Cell Culture Phase - Hi-GET® Technology

The expression vectors encoding a tumor-derived antibody are then introduced into mammalian cells. Individual cell lines producing the tumor-derived antibody are then generated using a series of growth and selection steps. This series of growth and selection, known as gene amplification, are completed using our proprietary Hi-GET® technology and permit the isolation of the cells that express high levels of the tumor-derived antibody. These cells are referred to as manufacturing cell lines.

Production Phase

Upon isolation of a manufacturing cell line, it is then grown to allow for the production of an appropriate amount of the tumor-derived antibody. Following a standard purification process, the tumor-derived antibody is linked to a desired immunologic carrier protein, which is currently KLH. After release testing, the frozen MyVax® Personalized Immunotherapy and adjuvant are shipped to the clinical trial site for patient immunization.