Technology Bundle ID: TAB-2639

Antigen-capture Electrochemiluminescent Assay for Determining Rabies Vaccine Potency

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Licensing Contact:
Co-Inventors: 
Charles Rupprecht (CDC)
Therapeutic Area: 
Infectious Disease
Development Status: 
  • Pre-clinical
  • In vitro data available
  • In vivo data available (animal)
Institute or Center: 
CDC

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.

Applications:
  • Rabies vaccine design and development
  • Vaccine quality control and quality assurance testing
  • In vitro assay for rabies virus glycoprotein
Advantages:
  • 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

Patents

PCT Application PCT/US2013/064911
Filed on 2013-10-15
US Application 14/434,910
Filed on 2015-04-10
US Application 61/713,130
Filed on 2012-10-12

Publications

Smith TG, et al.
PMID 23742991

Updated

Sep 17, 2013

Data Source: 
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