[Federal Register Volume 81, Number 95 (Tuesday, May 17, 2016)]
[Notices]
[Page 30543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11556]


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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 and/or co-development in the 
U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 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 and/or co-development.

ADDRESSES: Invention Development and Marketing Unit, Technology 
Transfer Center, National Cancer Institute, 9609 Medical Center Drive, 
Mail Stop 9702, Rockville, MD 20850-9702.

FOR FURTHER INFORMATION CONTACT: Information on licensing and co-
development research collaborations, and copies of the U.S. patent 
applications listed below may be obtained by contacting: Attn. 
Invention Development and Marketing Unit, Technology Transfer Center, 
National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, 
Rockville, MD 20850-9702, Tel. 240-276-5515 or email 
[email protected]. A signed Confidential Disclosure 
Agreement may be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.
    Title of invention: Method for Purifying Antibodies.
    Description of Technology: This technology is a method for 
purifying a biologic composition, comprising diafiltering the biologic 
composition into a composition comprising phosphate buffered saline 
(PBS) to obtain a purified composition. The method is particularly 
useful for removing one or more impurities from the biologic 
composition, such as bis(2-hydroxyethyl)amino-
tris(hydroxymethyl)methane (Bis-tris).The technology is directed to 
large scale manufacturing of Chimeric 14.18 (Ch14.18) monoclonal 
antibodies. Ch14.18 is an anti-GD2 monoclonal antibody and has been 
described in Gillies et al., Journal of Immunological Methods 125:191-
202 (1989).
    Potential Commercial Applications:
     Large scale manufacturing of chimeric monoclonal 
antibodies
    Value Proposition:
     Cost effective means of removing impurities to produce GMP 
grade chimeric antibodies for regulatory approval.
    Development Stage: Clinical Phase II, FDA/EMA approved Chemistry, 
Manufacturing and Controls (CMC) large scale manufacturing to produce 
GMP grade chimeric antibodies.
    Inventor(s): David A. Meh (United Therapeutics Corporation), 
Timothy Atolagbe (United Therapeutics Corporation), G. Mark Farquharson 
(United Therapeutics Corporation), Samir Shaban (National Cancer 
Institute), Mary Koleck (National Cancer Institute), George Mitra 
(National Cancer Institute).
    Intellectual Property:

    HHS Ref. No. E-291-2014/0-US-01, corresponding to US Provisional 
Patent App. No. 62/028,994, filed July 25, 2014, entitled ``Method for 
Purifying Antibodies using PBS''
    HHS Ref. No. E-291-2014/0-US-02, corresponding to US Patent App. 
No. 14/809,211, filed July 25, 2015, entitled ``Method for Purifying 
Antibodies using PBS''
    HHS Ref. No. E-291-2014/0-PCT-03, corresponding to International 
Patent App. No. PCT/US2015/042241, filed July 27, 2015, entitled 
``Method for Purifying Antibodies''

    Publications:

    1. FDA published document: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125516Orig1s000TOC.cfm
    2. US Food and Drug Administration. FDA approves first therapy for 
high-risk neuroblastoma.http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm437460.htm
    3. WO2016015048 METHOD FOR PURIFYING ANTIBODIES https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2016015048

    Contact Information: Requests for copies of the patent application 
or inquiries about licensing, research collaborations, and co-
development opportunities should be sent to John D. Hewes, Ph.D., 
email: [email protected].

    Dated: May 11, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology Transfer Center, National 
Cancer Institute.
[FR Doc. 2016-11556 Filed 5-16-16; 8:45 am]
 BILLING CODE 4140-01-P