Technology Overview
TransGenRx (TGRx) was founded in 2002, when it licensed from the Louisiana University Agricultural Center (AgCenter) Dr. Richard Cooper’s transfection patents and technology, allowing stable and efficient transfer of DNA into any host cell. This transfer of DNA is the cornerstone of modern production of therapeutic protein drugs or biologicals. The technology has several applications to emerging medical technologies, and TGRx chose to use the technology initially in the protein manufacturing industry because of the size of the market and the sustainable growth the industry has experienced over the past two decades. In addition, an emerging market of “generic” biologicals, or biosimilars, is predicted to grow to $45 billion over the next 15 plus years. This puts TGRx in a position to capitalize on the existing market of new drug development as well as to become a significant participant in the biosimilar marketplace, primarily because of the cost and time advantages of the core technology.
TGRx’s core technology is the use of the proprietary vector system that transfers DNA, such that the host cell can then produce large amounts of the desired protein encoded in the transferred DNA. The efficiency and stability of the transfection technology allows for rapid selection of stable clones of target cells that produce the protein of interest in nearly any cell needed for the production of a specific protein therapeutic. This adds to the advantage over any existing technology for the transfer of DNA and production of cells used in the manufacturing of biologics, ranging from new and innovative products to the production of biosimilars or proteins that have already been on the market and proven to be extremely valuable to the company that produces and sells these products.
In addition to the efficient and stable transfection that the technology accomplishes, it also allows for large amounts of DNA to be transferred, which results in an ability to transfer the proper regulatory elements, along with the coding region of the protein of interest. This results in transfected cells that produce large amounts of protein, which increases the efficiency of the manufacturing process. Through this increased efficiency, TGRx has several distinct advantages in entering the marketplace for protein therapeutics by applying the technology to the advancements made in cell culture systems that allow for rapid and cost-effective development of new or existing products that are now off-patent. Companies can then compete in both arenas – new drug development and biosimilar production. TGRx has built its facilities under FDA Good Manufacturing Practices and is in production of its first biosimilar product, a version of human growth hormone for which it already has customers. TGRx will be delivering its first product by the end of the first quarter of 2010. The use of the proprietary technology, coupled with the advancements in cell culture systems, has allowed TGRx to demonstrate its efficiency and speed to market, validating the market advantages that the technology holds. |
