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First Generation mAbs
The first generation therapeutic antibody market falls into two general categories of production, Transgenic Mice and Phage Display. These therapeutics are non-human products and ultimately inferior when compared to the Immunologix method.
Transgenic Mice
Immunizing mice which have had their innate antibody genes replaced with human antibody genes, allows for the production of human antibodies, but still requires immunization with an antigen, which is not possible with all antigens (some are toxic), followed by harvesting, plating, screening of the B-cells, isolation of mAb genes, and cloning into a production cell line.
Disadvantages:Transgenic Mouse platform systems are limited to the production of transgenic mice of a specific strain. To date, there are a number of antibodies that have been un-producible.
Phage Display
Bacteriophages can be engineered to display human monoclonal antibodies on their surface by inserting a human antibody gene into the phage population; the antibodies are then selected via standard antigen binding. The greatest advantage of this system is the vast size of the library that can be stored.
Disadvantages: The Phage Display Technology carries with it a number of disadvantages including size limitation of the protein sequence for polyvalent display, the requirement that proteins must be secreted from (bacteria). E. coli, and that all phage-encoded proteins are fusion proteins, which may limit the activity or accessibility for the binding of some proteins.
Second Generation mAbs:
Unlike these humanization techniques, the Immunologix in vitro human antibody development system generates fully human antibodies with human protein sequences. This technology fills the gap in the monoclonal antibody market and provides these unique and defining benefits for our customers:
Speed of Development – Production of humanized antibodies can take almost 600 days. In contrast, Immunologix fully human antibodies are delivered fully sequenced to the client within 145 days. Additionally, the Immunologix system enables rapid scale-up to commercial production quantities, allowing for seamless progress from the lab-bench to pre-clinical studies.
Production Cost – Humanized antibodies exceed two million dollars. Immunologix fully human antibodies cost in the range of .5 to 1 million dollars.
Diversity – Immunologix technology has the potential to generate high binding affinity human antibodies to target any and all antigens. Because these antibodies are produced without the need for subsequent engineering to make them more human, there is no danger of damaging their original potency.
Small Molecule or Monoclonal Antibody1?
The prescription pharmaceutical market represents four vastly different segments: small molecule, therapeutic protein, monoclonal antibody and vaccine. While the small molecule segment holds will continue to hold the lion’s share (75.7% of total market sales by 2012), a very nominal growth rate of 0.6% is expected. In stark contrast, the monoclonal antibody segment will account for 8.9% of total market sales but experience an explosive growth rate of 14.2%. The difference in these growth factors can be attributed to the dominance of monoclonal antibodies over small molecules in three key areas.
- Generic Competition. Small molecules are the target of a booming generics industry while monoclonal antibodies will be protected from generic competition until 2012 due to regulatory, technical and intellectual property barriers.
- Higher Revenue. mAbs command an average revenue per product premium two times that of small molecules.
- Higher Demand. mAbs have the ability to address therapeutic areas of high unmet need and lower competitive intensity, thus increasing their demand and feeding their revenue stream.
Market forecasters expect that during the next five years, the industry has the potential to double the number of mAbs and can anticipate a tripling of the global market for mAb products.
1Data Monitor, September 2007