National Eye Institute; Notice of Meeting, 65167 [2019-25687]
Download as PDF
<![CDATA[
Federal Register / Vol. 84, No. 228 / Tuesday, November 26, 2019 / Notices
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 singlesystem, 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
VerDate Sep<11>2014
16:47 Nov 25, 2019
Jkt 250001
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;
dianca.finch@nih.gov.
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Eye Institute; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory Eye
Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Eye Council.
Date: January 17, 2020.
Open: 8:30 a.m. to 12:00 p.m.
Agenda: Following opening remarks by the
Acting Director, NEI, there will be
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
65167
presentations by the staff of the Institute and
discussions concerning Institute programs.
Place: National Eye Institute, 6700B
Rockledge Drive, 1st Floor Conference Room,
Bethesda, MD 20817.
Closed: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Eye Institute, 6700B
Rockledge Drive, 1st Floor Conference Room,
Bethesda, MD 20817.
Contact Person: Anne E. Schaffner, Ph.D.,
Chief, Scientific Review Branch, Division of
Extramural Research, National Eye Institute,
National Institutes of Health, 6700 B
Rockledge Dr. Ste 3400, Bethesda, MD
20892–9300, (301) 451–2020,
aes@nei.nih.gov.
Information is also available on the
Institute’s/Center’s home page:
www.nei.nih.gov, where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.867, Vision Research,
National Institutes of Health, HHS)
Dated: November 21, 2019.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–25687 Filed 11–25–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Interagency Coordinating Committee
on the Validation of Alternative
Methods Communities of Practice
Webinar on Use of Animal-Free Affinity
Reagents; Notice of Public Webinar;
Registration Information
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The Interagency Coordinating
Committee on the Validation of
Alternative Methods (ICCVAM)
announces a public webinar ‘‘Use of
Animal-free Affinity Reagents.’’ The
webinar is organized on behalf of
ICCVAM by the National Toxicology
Program Interagency Center for the
Evaluation of Alternative Toxicological
Methods (NICEATM). Interested persons
may participate via WebEx. Time will
be allotted for questions from the
audience. Information about the
webinar and registration are available at
https://ntp.niehs.nih.gov/go/commprac2020.
SUMMARY:
DATES:
Webinar: January 21, 2020, 11:00 a.m.
to approximately 12:30 p.m. EST.
E:\FR\FM\26NON1.SGM
26NON1
]]>Agencies
[Federal Register Volume 84, Number 228 (Tuesday, November 26, 2019)]
[Notices]
[Page 65167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25687]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Eye Institute; Notice of Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of a meeting of the National Advisory
Eye Council.
The meeting will be open to the public as indicated below, with
attendance limited to space available. Individuals who plan to attend
and need special assistance, such as sign language interpretation or
other reasonable accommodations, should notify the Contact Person
listed below in advance of the meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Advisory Eye Council.
Date: January 17, 2020.
Open: 8:30 a.m. to 12:00 p.m.
Agenda: Following opening remarks by the Acting Director, NEI,
there will be presentations by the staff of the Institute and
discussions concerning Institute programs.
Place: National Eye Institute, 6700B Rockledge Drive, 1st Floor
Conference Room, Bethesda, MD 20817.
Closed: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Eye Institute, 6700B Rockledge Drive, 1st Floor
Conference Room, Bethesda, MD 20817.
Contact Person: Anne E. Schaffner, Ph.D., Chief, Scientific
Review Branch, Division of Extramural Research, National Eye
Institute, National Institutes of Health, 6700 B Rockledge Dr. Ste
3400, Bethesda, MD 20892-9300, (301) 451-2020, [email protected].
Information is also available on the Institute's/Center's home
page: www.nei.nih.gov, where an agenda and any additional
information for the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.867,
Vision Research, National Institutes of Health, HHS)
Dated: November 21, 2019.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-25687 Filed 11-25-19; 8:45 am]
BILLING CODE 4140-01-P
