NeoClone ABL-MYC Technology and Products: Enormous demand for mAbs is being met primarily through a complex, labor-intensive, and lengthy process involving the twenty five year old hybridoma technology (portrayed on the left side of Figure 1) . It requires the fusion and selection of cells in tissue culture to form a new, immortalized cell, an extremely sophisticated and labor-intensive process. Producing a new, custom mAb via the hybridoma method takes between four to eight months. Unfortunately, hybridomas are intrinsically unstable cells and this weakness in the technology can extend this time frame even further.
Generally, the production of one mAb, using the hybridoma technology, costs between $8,000 and $12,000. The average reasonably skilled employee can generate only 15 to 30 hybridoma fusions per year, but in an environment where the focus is on diagnostic- or therapeutic-quality mAbs, there are additional significant limitations than can further decrease throughput.
The Company’s patented technology has the capacity to address major industrial needs for a faster, lower cost and better quality process. Many of the steps in making hybridomas are similar to those involved with NeoClone’s ABL-MYC technology. The crucial difference is the ABL-MYC immortilization step (highlighted in yellow in Figure 1) requires less than a day (versus two or more months through the chemistry of the fusion protocol) AND produces a completely stable cell line (versus unstable cells for hybridoma). Therefore, with our process, no hybridomas need to be selected through laborious culturing and subcloning since the resulting cell line only produce the desired mAbs to the immunizing antigens.
This provides NeoClone with the following important advantages over the hybridoma technique are:
- A significant reduction in the cost of production;
- A decrease in development time by 33% to 50%;
- A dramatically higher thoughput per employee;
- A dramatic increase in cell line stability providing consistent mAbs both now and in the future; and
- Ultimately, NeoClone has the potential for culturing vastly greater numbers of ASPs, actively secreting high-affinity, desirable mAbs, in comparison to laborious hybridoma selection and cloning.
These advantages place NeoClone in a unique position to improve and develop diagnostic tools, general and proteomic research tools and ultimately drug treatments with improved clinical success rates.
