Manufacturing Biologics Smarter

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Protein therapeutics, or biologics, is the fastest-growing segment of the pharmaceutical industry, with sales expected to grow to $14 billion annually by 2014. Traditional manufacturing facilities for these types of drugs are costly, with an average facility costing $400 million and taking up to five years to build. These systems operate using large stainless steel vessels and miles of stainless pipes. Recent developments, however, have resulted in more intensive culture systems that have a smaller footprint and rely on disposable components to minimize the clean-in-place/sterilize-in-place requirements of biologics production. While the culture technology has progressed, the actual cell transformation and expression technology has not progressed as rapidly and often still relies on batch technology. TGRx’s breakthrough technology uses the more cost-effective culture technology and decreases the clone production time because of the more rapid generation of cell clones expressing a desired protein and the amount of protein that is expressed. Our technology allows perfusion culture (instead of batch culture) because the protein is secreted from the cells at a high rate; therefore, we can keep the system operational for months to reduce costs associated with production. TGRx has the potential to significantly lower the cost of protein drug production and is in negotiations for contracts to produce proteins to treat human diseases, including cancer, and generic biologic products.
TGRx, in partnership with the LSU AgCenter, has developed a technology that significantly reduces the cost of manufacturing protein-based drugs. TGRx was established in 2002 to harness the potential of the chicken as a bioreactor and the egg as the perfect package for protein production on a commercial scale. During the course of this research, discoveries have been made that have resulted in greatly improved protein expression in cell culture. While work continues with the chicken, the advances made in cell culture will allow TGRx to enter the commercial arena by the first quarter of 2010.
How the Technology Works
The developer of the technology used by the company is LSU AgCenter scientist Dr. Richard Cooper, a professor of veterinary science. He developed an efficient method that forces DNA to integrate into a target genome. To date, numerous animals and cell lines have been transfected for the purpose of making either a transgenic animal or for use as gene therapy. Whether making a transgenic animal or cell line, the rate of integration allows large numbers of animals and cells to be generated, thus decreasing the amount of time to commercialization.
The company’s core technology involves the targetedintegration of a desired gene sequence into virtually any animal or cell culture system and the controlled expression of that sequence to achieve a desired outcome (protein production, gene therapy, etc.). Read the Technology Overview. Through the creative use of its technology, TGRx is poised to enter the market with virtually unlimited growth potential. This technology will make it possible to save millions of lives through the production of protein therapeutics and diagnostics that have not been economically feasible to produce in the past.
Our ability to rapidly generate stable cell lines coupled with hollow fiber perfusion technology makes it possible to quickly provide a customer with preclinical quantities of a protein. Using pilot scale production, several proteins can be produced at one time to allow a customer the ability to test different versions of a drug candidate. When a decision is made on one for further development, scale up to production quantities is rapid, cost effective, and seamless.
Where We Are Located
In April 2008, TGRx moved into a 23,000-square-foot space within the Louisiana Emerging Technology Center, a new building opened in late 2005 on the LSU campus. This center, which is operated by the LSU Research and Technology Foundation, is a business incubator for start-up biotechnology companies. The center offers state-of-the-art laboratory equipment and space to help its tenants get their businesses up and running. The center was established through special funding from the Louisiana Legislature through Louisiana Economic Development to spur new high-tech business for the state.
How to reach us
TransGenRx Inc.
340 East Parker Blvd.
Baton Rouge, LA 70803
Phone: (888) 432-0721
e-mail: bizdev@tgrx.com
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