TransGenRx

TGRx brings to protein manufacturing distinct advantages over other methods, including the area of transgenic production. These include:

Targeted and stable integration into the host genome (transfection rates up to 70%).
Predictable and traceable patterns of inheritance that ensure continuity of expression from generation to generation. Ongoing experimentation shows stability through the third generation (G3).
Tissue specific transgene expression. Proprietary vector technology allows targeting expression in specific tissues and cell types.
Development of a Rapid Expression System™ (RES) in quail and a cell culture system for chickens that allows production of mg quantities of protein in 90 days.
Targeted protein expression in chicken and quail yield expression rates of more than 1 mg of desired protein per ml of egg white.
Simple and scalable purification methods standard in the industry.
Fifty years of safety and regulatory approval of human biologics derived from chicken eggs (vaccines).

Currently, TGRx has proof of concept using a fusion protein consisting of ovalbumin-human proinsulin. The company has demonstrated expression rates in excess of 1 mg/ml using its RES in quail. The company has also demonstrated protein synthesis in cells derived from oviduct explants. This system is currently being used to optimize protein expression in the egg white. The combined use of germ line transmission, oviduct-specific gene insertion (RES) and chicken cell culture provide TGRx tremendous potential to produce quantities of protein from reference samples and preclinical amounts to commercially desirable levels.

Using two genes, DsRed and human proinsulin, TGRx has demonstrated sperm carrying the transgene for nine months and seven months, respectively. Likewise, the company has shown, using RES, protein production over the laying life of a quail (approximately six months). Both sets of data demonstrate stable incorporation into progenitor cells. TGRx has made tremendous progress in transfecting both male and female animals. Using a simple technique of vascular injection of the vector, TGRx scientists have demonstrated that the oviducts and the ovaries of the female birds are transfected. This approach also increases the transfection rate of the females in excess of 90%. Combined with testicular injection in the male, these procedures save approximately 27 weeks, or one whole generation, in the time required to amplify a specific flock of chickens to full production status. Again, this advancement provides the ability to produce females using the Rapid Expression System and dramatically shortens the time to full production status.

Through a variety of analytical methods, including liquid 2D fractionation, SDS-PAGE gel electrophoresis, Western blots, ELISA and MALDI-TOF, TGRx has proved sequence and expression rates. In addition to these data, the company has DNA vectors either in birds or in production to produce a human growth hormone, an anti-anthrax protein and a monoclonal antibody for fighting cancer. The latter two are under contract. Proof of concept for each of these vectors will occur within the next few months. The company has been asked to produce test proteins for the Centers for Disease Control, Defense Advanced Research Projects Agency (DARPA) and the National Cancer Institute. Successful completion of these test proteins could quickly lead to large government production contracts.

While competitors are trying to develop methods for stable germ line integration, TGRx, having overcome this problem, is able to concentrate on increasing protein expression. With a baseline established for proinsulin, modifications are being made to optimize expression and protein purification. These modifications will instruct us in the design of other proteins under contract.

The time frame in which TGRx can produce protein for reference samples, preclinical and clinical studies is unprecedented in the industry. TGRx can produce reference and preclinical amounts in as little as three to six months, initial production levels at six to nine months and full production in 18 months, depending upon the amount of protein required by the client. The procedures are completely scalable, and meeting increased production demand is rapid and seamless. TGRx has the ability to produce approximately 20kg of raw material in 2007. This total production can be expanded quickly when the need arises through production contracts or partnerships.