Current Challenges of Digoxin Immune Fab
Digoxin Immune Fab (Digixin-specific Fab Fragment) is a drug of “digoxin antidote” for specific treatment of life-threatening or potentially life-threatening digoxin toxicity/overdose. Driven by demographic trends, such as an increasing aged population, the global economic growth, there is a significant buoyant growth forecast for “Digoxin Immune Fab” in the future.
Currently, the available Digoxin Immune Fab is a sheep polyclonal anti-digoxin antibody produced from the hyperimmune ovine serum. Due to the limitations of productivity, Digoxin Immune Fab (ovine) suffers from the following disadvantages, making the product unavailable/shortage on the market at times and few manufacturers want to join this battle to become a major player even though the demand for the product is increasing.
- Very High Production Cost (Unaffordability)
- Low Productivity/Low Yields (Shortage at times on the market)
- Biohazard risk of TSEs: for the biologicals produced from sheep, scrapie, or other transmissible spongiform encephalopathy agents (TSEs) were potential problems.
IgY(ΔFc) derived Digoxin Immune Fab
Fortunately, the above-mentioned issues can be solved by Good Biotech’s new generation IgY(ΔFc) derived Digoxin Immune Fab, produced from hyperimmune duck egg yolk. Promising results were obtained from the feasibility study on the neutralization efficacies in digitalized animals with excellent productivity from hyper-immune duck eggs. This study indicates the development of Anti-Digoxin, IgY(ΔFc)-Fab will be of great value for further proceeding the applications, not only as an antidote for the treatment of digoxin toxicity or overdose but also as a candidate for the treatment of serve pre-eclampsia.
The Advantages of IgY(ΔFc) derived Digoxin Immune Fab in Comparison with Currently Available Ovine IgG-based Digoxin Immune Fab
- Excellent Productivity: Productivity (vials/kg body weight/animal/year) is much higher.
- Ease of handling and maintenance in large numbers of ducks for immunization. The industrial scale of production of millions of vials of Digoxin Immune-Fab [(Duck IgY(ΔFc)] in one single plant is available and has great commercial value.
- Higher Safety: Free from the potential risk of TSE pathogens. In addition, IgY(ΔFc) antibody is not an allergen; patients with allergic reactions can avoid it.
It is well known that the clinical success of biotherapeutics will depend on the Productivity and Production Cost. Good Biotech’s Anti-Digoxin IgY(ΔFc) Immune Fab from egg yolk possesses significant advantages, such as superior productivity (high yields), cost-effective, simple downstream processing & avoidance of the BSE biohazard risk caused by sheep, can contribute to the treatment of Digoxin toxicity/overdose and even for the treatment of severe preeclampsia. It is expected that the development of Digoxin Immune Fab from duck IgY(ΔFc) technology will have vital benefits: with the ability to produce & supply sufficient quantities of IgY(ΔFc) derived new generation Digoxin Immune Fab to meet the market demand with competitive price.
Good Biotech is seeking a Strategic Partnership to advance this exciting project:
The development of the next-generation Digoxin Immune Fab from hyperimmune duck IgY(ΔFc) antibodies as a drug candidate for the treatment of severe preeclampsia. (Click for more information)
If you are interested in exploring partnering with Good Biotech, please contact our Partnering Team at partnership@good-biotech.com.
