Technology ID
TAB-4611

Novel F(ab’)2 Antibodies for the Detection of Bacillus Anthracis Lethal Factor

E-Numbers
E-006-2018-0
Lead Inventor
Epperson, Monica
Lead IC
CDC
Co-Inventors
Kamal, Nazia
Schiffer, Jarad
Maniatis, Panagiotis
ICs
CDC
Applications
Research Materials
Diagnostics
Therapeutic Areas
Infectious Disease
Development Stages
Analytical Assay Performance Stage
Research Products
Antibodies

This technology includes human F(ab’)2 fragments specific for anthrax lethal factor for the development of a lateral flow immunoassay for Bacillus anthracis Lethal Factor. The F(ab’)2 fragments are generated from a Human Combinatorial Antibody Library (HuCAL) and are highly specific with high affinity. A multi-step process was utilized beginning by screening a phage display library with over 45 billion functional human antibody specificities. The primary screen against Bacillus anthracis Lethal Factor (LF) generated 360 positive clones. This was followed up by a step to reduce non-specific interactions to normal human serum resulting in more specific F(ab’)2. -Bio- Layer Interferometry identified 95 high affinity clones. Sequencing of the 20 highest affinity clones revealed 12 unique F(ab’)2 antibodies. These 12 antibodies were evaluated for LF detection using sandwich ELISAs. The F(ab’)2 were screened as both capture and detection antibodies to identify possible LF detection pairs.

Commercial Applications
The F(ab’)2 fragments have been used in conjunction with mouse mAbs to develop a lateral flow immunoassay for Bacillus anthracis Lethal Factor. The research has established optimized device conditions and is being currently being evaluated for sensitivity and specificity; at that point, the device will be ready to be transferred to a 3rd party manufacturer to seek 510k approval. In addition to use in a lateral flow immunoassay the F(ab’)2 can be used in multiple platforms for anthrax diagnostics.

Competitive Advantages
The human F(ab’)2 fragments provide a unique and distinct advantage to mouse monoclonal antibodies:
  • The F(ab’)2antibodies lack the Fc region and their use, either in Fab-Fab or Fab-mAb pairs eliminates interference by HAMA or heterophilic antibodies.
  • The F(ab’)2 fragments are highly reproducible in a time efficient manner from E.coli stocks from the phage display thus not requiring animal immunizations.
Licensing Contact:
Motley, Jonathan
jonathan.motley@nih.gov