Clonex Development, Inc.

211 E. Ohio Street
Suite 2619
Chicago
Illinois
60611
United States

Tel: 877-864-8144
Fax: 312-467-7069

Email: info@clonexdevelopment.com

About Clonex Development, Inc.

Clonex Development Laboratories
3587 Anderson Street
Suite 103
Madison, WI 53704
Phone: 608-310-9575
Fax: 608-310-9579

Introduction
Clonex Development, Inc. has developed an innovative technology for increased yield of bioproducts, manufactured in cellular systems. Genetic engineering technology is used to control the metabolism of cells, thus shifting the cell from replicative to production mode (RP Shift®). In particular, this technology has been designed for use in mammalian cells, unlocking their potential to produce proteins, peptides and enzymes. The current design of the technology can be readily translated to bacterial and yeast cellular systems for the production of commercial grade bioproducts.

Corporate Description
Clonex Development, Inc. (CDI), a closely held (the founders retain 100% of the stock) S Illinois corporation, has offices located in Chicago, Illinois. CDI moved its laboratory operations into 2800 square feet of space at the TEC Center in Madison, Wisconsin in April of 2005. CDI was founded by Thomas Primiano, Ph.D., currently serving as President and Chief Executive Officer, and Todd Bucciarelli, serving as Secretary and Chief Financial Officer on April 7, 2000. The company currently employs nine full and part-time scientific, business and administrative professionals. CDI was awarded patent #6,635,448 in October 2003 for its RP Shift® technology.

Technology Description
RP Shift® technology is based on conditionally producing a phenotypic change in biopharmaceutical producing cells in culture. Cells undergoing RP Shift® stop dividing, increase their volume, increase numbers of mitochondria, expand their endoplasmic reticulum , and increase their synthesis and secretion of protein. Such cells have longer lifespan and are also substantially more resistant to environmental stresses, such as lowered pH, loss of serum factors, osmotic changes and other impedance that triggers cell death in proliferating population. By these virtues, RP Shift® increases cell stability, and allows higher concentration of secreted products.

CDI has routinely demonstrated 5-10-fold RP Shift® enhancement of the production of protein from fibroblast, Chinese hamster ovary, and mouse myeloma cells. CDI has also demonstrated greater than 30-fold increase in the production of a monoclonal antibody from hybridoma cells in a static culture system.

CDI has produced plasmid systems containing the RP Shift® constructs that may be readily introduced into any mammalian cell line. A timeline of approximately ten weeks is necessary to isolate clones ready for testing for RP Shift® enhancement of protein production. An additional 3-6 months is required for complete analysis of the RP Shift® enhancement at analytical and commercial scales.

CDI has also generated CHO, NS0 and Sp20 cell lines with RP Shift® into which any protein expressing construct may be cloned.
Last Updated: 03-27-2006

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