Anti-Digoxin Fab

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 trend, 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 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 of 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 sheeps, 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 Imuune 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 treatment 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 50 times higher.
  •  Ease of handling and maintenance in large numbers of ducks for immunization. The production of 1 million vials in one single plant is available.
  •  Higher Safety:Free from the potential risk of TSE pathogens. In addition,IgY(ΔFc) antibody is not an allergen; patients with allergic reactions can be avoided.  
 

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 possessing significant advantages, such as superior productivity (high yields), cost effective, simple downstream processing & avoiding to the BSE biohazard risk caused from 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 the vital benefits that: with the ability to produce & supply sufficient quantities of IgY(ΔFc) derived new generation Digoxin Immune Fab to meet the market demand with very competitive price.

 

Good Biotech is seeking Out-Licensing/Collaborations to advance this exciting project. If you are interested in exploring partnering with us, please contact: partnership@good-biotech.com