Antigen-capture Electrochemiluminescent Assay for Determining Rabies Vaccine Potency


CDC researchers developed a more efficient method of assessing rabies vaccine potency using an antigen-capture electrochemiluminescent (ECL) assay. This assay utilizes SULFO-NHS-Ester labeled murine monoclonal antibodies to quantify glycoprotein concentration, which is an indicator of vaccine potency. Currently, the potency of rabies vaccines is determined by the effective-dose (ED50) mouse study evaluation method, which is more than 50 years old. The labor-intensive ED50 evaluation method has high operating costs, extensive biosafety requirements, and requires the sacrifice of a large number of animals. CDC researchers have addressed these issues by developing a competitive in vitro antigen-capture assay that is rapid, highly robust, reproducible, flexible and much less expensive to implement than the traditional ED50-mouse study evaluation.

Potential Commercial Applications: Competitive Advantages:
  • Rabies vaccine design and development
  • Vaccine quality control and quality assurance testing
  • In vitro assay for rabies virus glycoprotein
 
  • Efficient vaccine evaluation
  • Highly robust, reproducible and flexible
  • Easily standardized for consistent, universal usage and assurance of batch-to-batch vaccine homogeneity
  • In vitro assay may replace the 50 year old ED50 mouse procedure


Development Stage:
  • Pre-clinical
  • In vitro data available
  • In vivo data available (animal)


Related Invention(s):
E-256-2013-0
E-326-2013-0


Inventors:

Charles Rupprecht (CDC)  ➽ more inventions...


Intellectual Property:
US Application No. 61/713,130
PCT Application No. PCT/US2013/064911
US Application No. 14/434,910

Publications:
Smith TG, et al. PMID 23742991

Licensing Contact:
Jeremiah Mitzelfelt,
Email: jeremiah.mitzelfelt@nih.gov
Phone: 301-443-8518

OTT Reference No: E-180-2013-0
Updated: Sep 17, 2013