[Federal Register Volume 84, Number 228 (Tuesday, November 26, 2019)]
[Notices]
[Pages 65166-65167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25620]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing to achieve expeditious 
commercialization of results of federally-funded research and 
development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing.

FOR FURTHER INFORMATION CONTACT: Dianca Finch, Ph.D., 240-669-5503; 
[email protected]. Licensing information and copies of the U.S. 
patent application listed below may be obtained by communicating with 
the indicated licensing contact at the Technology Transfer and 
Intellectual Property Office, National Institute of Allergy and 
Infectious Diseases, 5601 Fishers Lane, Rockville, MD, 20852; tel. 301-
496-2644. A signed Confidential Disclosure Agreement will be required 
to receive copies of unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows:

A High-Yield Perfusion-Based Transient Gene Expression Bioprocess

Description of Technology

    Currently, fed-batch processes are the most commonly used 
bioprocesses in transient gene expression (TGE) vaccine manufacturing. 
However, because fed-batch processes keep all the cells and protein 
product in the vessel throughout the run, some limitations are 
intrinsic. First, waste products like cell debris or

[[Page 65167]]

other unwanted small molecules accumulate in the vessel with a 
potential to disrupt the cell growth, protein production, and the 
stability of the generated protein of interest. Second, necessary 
buffer exchange and/or cell concentration steps must be performed 
outside of the culturing vessel. These steps are more involved and 
increase the risk of contamination. Lastly, even with the addition of 
daily supplementation in the fed-batch process, there are limitations 
in length of time that the transfected cells remain viable and 
productive.
    Researchers at the Vaccine Research Center (VRC) of the National 
Institute of Allergy and Infectious Diseases (NIAID) developed a new 
transient gene expression (TGE) bioprocess using a perfusion system 
that resolves the current fed-batch limitations for influenza vaccine 
production. The major components of this technology are two-fold: the 
optimization of conditions for polyethylenimine (PEI)-mediated gene 
transfection in the bioreactor without the interference of 
microbubbles; and the implementation of a perfusion-based alternating 
tangential flow (ATF) system for single-system, prolonged cell culture, 
combining the steps of cell concentration, waste clearance, culturing/
media replenishment, and protein expression within a single vessel.
    The development of the TGE bioprocess included optimization of 
conditions for HEK293 cell growth in the bioreactor, optimized 
transfection mediated by PEI, and protein expression for an extended 
period to achieve reproducibility and high protein yield.
    Due to high improvement in cell growth and protein production 
without external handling, this bioprocess could lead to substantial 
cost saving and other benefits in vaccine and drug manufacturing of 
clinical grade materials.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404.

Potential Commercial Applications

     Bioprocess--A single-use protein production platform for 
transient gene expression (TGE) with potential applications in rapid 
protein expression as well as vaccine and drug manufacturing.

Competitive Advantages

    The new transient gene expression (TGE) bioprocess for vaccine 
manufacturing has the following features compared to commonly used 
related processes such as fed-batch:
     Robust, prolonged cell growth.
     High levels of protein production and reproducibility.
     Cost efficiency.
     Reduction in contamination risk.
    Development Stage: Final Product.
    Inventors: Jinsung Hong, Ph.D. (NIAID); Jacob Demirji, Ph.D. 
(NIAID); Daniel Blackstock, Ph.D. (NIAID); and Joe Horwitz, Ph.D. 
(NIAID).
    Intellectual Property: HHS Reference Number E-187-2018 includes 
U.S. Provisional Patent Application Number 62/751,204 filed 10/26/2018.
    Licensing Contact: To license this technology, please contact 
Dianca Finch, Ph.D., 240-669-5503; [email protected].

    Dated: October 10, 2019.
Wade W. Green,
Acting Deputy Director, Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases.
[FR Doc. 2019-25620 Filed 11-25-19; 8:45 am]
 BILLING CODE 4140-01-P