List of Cellca’s Intellectual Property Rights

Cell Culture Media:

Trade Secret – Description:

The basal, the stock and the feed of the cell culture media are designed to meet the specific cell metabolism requirements of the CHO host cell line. The media is developed to promote high cell growth and productivity and reduce the metabolic waste production. The individual components have been carefully selected to improve solubility. In addition, the selective agent concentration in the media is optimized for the promoter activity of the selective gene of the vector.

Patent Application:

Cell Line:

License – Description:

The Cell Line is licensed by Cellca as the Licensee from Lawrence Chasin and Gail Urlaub Chasin as the Licensors. The License provides for a non-exclusive, perpetual, transferable and sub-licensable right to use the Cell Line to develop, conduct clinical trials for, formulate, manufacture, test, seek regulatory approval for, market, commercialize, make, have made, use, sell, import and distribute the Product, for which Cellca has provided lab-scale development services. The License has been granted effective March 17, 2008 and was amended by written agreement dated June 14, 2010.

Trade Secret – Description:

The trade secret consists of two parts, namely the cell line adaptation and the clone selection.

The clone selection procedure, based on FACS, has been developed by Cellca and is based upon the selection marker gene of the vector. Single cell cloning is performed in an animal component free environment and is developed to promote high producing clones.

The licensed wild type cell line has been carefully adapted to meet the large scale requirements for stability.

Patent Application:

Upstream Process

Trade Secret – Description:

The upstream process design allows easy, fast scalability and robustness. The cell growth during the culture expansion phase is optimized for a fast process time. The feeding regime is designed for simplicity, w/o daily calculations, on-line measurements etc, which reduces variability. The process parameters like pH, DO, temperature are optimized to keep the process constant, reducing variability. The harvest protocol is optimized for high cell concentration and particle load.

Trade Secret

The cell and molecular biological regulatory genetic elements of the expression cassette have been carefully selected and the distance between the genes is optimized. The promoter activities can be regulated depending the gene expression.