Post-Award Notice-Justification for ATUM Evaluation License and Materials: Cell Line Development Expression Vector Optimization

The National Institute of Allergy and Infectious Diseases (NIAID)’s Vaccine Research Center (VRC) has a Vaccine Production Program (VPP) with a Cell Line Development team that is responsible for generating specific clonally-derived cell lines expressing monoclonal antibodies and vaccine candidates that will be used for manufacturing material that is acceptable for use in human clinical trials. This process begins with transfection of a mammalian cell line with plasmid DNA encoding the protein of interest. DNA TwoPointO, Inc., d/b/a ATUM (“ATUM”) has expression vectors that are based on unique proprietary technology, synthetic transposons. ATUM’s unique technology provides the only commercially available transposon-based system, which is a specific way of integrating the genes into the host cell line that uniquely meets the requirements of our project. This specific technology results in higher-producing clones than the random integration system that the VPP currently uses. More importantly, this transposon-based technology results in faster and more reproducible pool and clone generation, which would potentially allow the VPP to move projects forward much more quickly. Other alternative methods for exogenous gene expression are vulnerable to truncation, deletion, scrambling, and other problems that can occur during the random integration processes that are commonly used in cell line development. ATUM’s transposon based process is able to avoid these issues and the selection process is therefore accelerated; creating higher-producing clones at a consistent product quality, which will save significant time and money.

Reference attached Limited Source Justification. 

Awarded contract 75N93021P01384 to unknown vendor for unknown amount on 2021-09-20.