Improved Protein Quantification Process and Vaccine Quality Control Production


This CDC invention is a method for identifying and quantifying a group of proteins in a complex mixture by a liquid chromatography-tandem mass spectrometry assay. The technology was developed for influenza although it can be used for a wide variety of protein quantification applications. As specifically developed, conserved peptides from the proteins of influenza (hemagglutinin, neuramidase, matrix 1 and 2, and nucleoprotein) have been synthesized and labeled to be used as internal standards for the quantification of those proteins in a complex (biological or manufactured) matrix. One or more of these peptides can be used to simultaneously detect and quantify the target proteins by establishing mass ratios and calibration curve comparison. This method for quantifying influenza proteins and peptides in samples has potential for improving vaccine production quality control and therefore, the effectiveness and overall cost-efficiency of influenza vaccines.

Potential Commercial Applications: Competitive Advantages:
  • Vaccine production, especially influenza-related
  • Quality assurance, quality control
  • Influenza surveillance programs
 
  • Simultaneous, precise protein detection and quantification for complex mixtures
  • Rapid; method cuts investigation/research time needed to formulate and optimize novel vaccines for emergent influenza strains
  • Improved vaccine cost and production efficiency


Development Stage:
  • Early-stage
  • In vitro data available


Inventors:

Tracie Williams (CDC)  ➽ more inventions...

James Pirkle (CDC)  ➽ more inventions...

Ruben Donis (CDC)  ➽ more inventions...

Leah Luna (CDC)  ➽ more inventions...

Zhu Guo (CDC)  ➽ more inventions...

John Barr (CDC)  ➽ more inventions...


Intellectual Property:
U.S. Pat: 8,530,182 issued 2013-09-10
PCT Application No. PCT/US2008/013396
US Application No. 12/746,649

Publications:
Williams TL, et al. PMID 18440105
Pierce CL, et al. PMID 21591780
Williams TL, et al. PMID 22197963
Woolfitt AR, et al. PMID 19364092

Licensing Contact:
Tara Kirby, Ph.D.
Email: tara.kirby@nih.gov
Phone: 240-669-5128

OTT Reference No: E-212-2013/0
Updated: Dec 23, 2013