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Scientific Background
Modern Biotechnology and Its Limitations
In recent years, biotechnology has focused on genomics to identify tens of thousands of genes. However, the pathway from genomics to a valuable biopharmaceutical product is long and unpredictable. Thousands of genes can be identified in an afternoon but it is more difficult to elucidate the function of a gene. It is even more difficult to then adapt the genomic discovery to the production of a useful therapy.
In some cases, the protein products of those genes can be directly applicable as drugs. In those cases, the protein is produced by rapidly maturing recombinant DNA technologies. But, a majority of the proteins discovered by scientists and produced by recombinant DNA technology have not been commercially successful. Sometimes a recombinant protein¡¦s unsuitability as a therapeutic product is not discovered until it has gone through clinical trials.
In other cases, there are functions that result from the actions of multiple genes and proteins, or multiple biological reactions. Even more difficult are genes whose functions require that the gene be replaced or inactivated for therapeutic effect. It is difficult to establish proof of efficacy in these areas and downstream product development must rely on speculative technologies. Costs are unknown and the time to market may be many years.
The disadvantages of therapeutic monoclonal antibody (mAb)The major limitation of monoclonal antibody production is dosing. Frequent intravenous injections of high amounts of the recombinant mAb protein is often required to achieve clinical efficacy. As a result, the cost of each round of treatment is extremely high.
Advantages of Peptide Immunotherapeutics over Monoclonal Antibodies
UBI does consider passive immunotherapy by infusion with monoclonal antibodies as a useful approach in situations where active immunotherapy by a vaccine is unfavorable, such as where an immediate effect if needed or where patients may be immunocompromised.
The UBI Approach
We use the fruits of genomic research to select promising genes whose functions are known. Then we model the target protein using proteomics and we reproduce candidate ligand or receptor sites as synthetic peptides. We select only those potential products that will rapidly yield to our core technologies in functional antigenics. We avoid the direct use of peptides as drugs because peptide drugs have poor stability and bioavailability in the body. Rather, we refine our site-directed peptides to act indirectly through the immune system, as immunogens for the stimulation and production of site-specific antibodies. Our immunogens are chemically defined molecules manufactured by synthetic peptide chemistry. Our technologies are fast in execution and directed to immediate commercial application. We can screen many candidates rapidly and inexpensively. We can identify, optimize, and establish the feasibility of potential biopharmaceutical products in a time frame as short as 6 months. Our product development pathways then follow through the empirical procedures of immunology, while relying on our proprietary processes for optimizing peptide synthesis, and our proven technologies for vaccine development. We have effectively protected our proprietary technologies by obtaining worldwide patent protection.
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