SBIR Phase II: Scale-up Manufacturing of Nitric Oxide Nanotechnology for Healthcare Infections

Information

  • NSF Award
  • 1127380
Owner
  • Award Id
    1127380
  • Award Effective Date
    11/1/2011 - 13 years ago
  • Award Expiration Date
    12/31/2013 - 10 years ago
  • Award Amount
    $ 990,032.00
  • Award Instrument
    Standard Grant

SBIR Phase II: Scale-up Manufacturing of Nitric Oxide Nanotechnology for Healthcare Infections

This Small Business Innovation Research (SBIR) Phase II project aims to develop the process and engineering controls necessary to scale up the manufacturing of a nitric-oxide-releasing active pharmaceutical ingredient (API). One of the applications is a wound-healing product for diabetic foot ulcers. This project will focus on 1) optimizing the process parameters required to scale production of a nitric-oxide-releasing API to reproducible 1 kg batches, and 2) implementing the analytical methodologies to meet the requirements of the Chemistry, Manufacturing and Control (CMC) sections of an Investigational New Drug (IND) application. The expected outcome is a manufacturing process capable of producing large batches of the API that are suitable for an IND submission of a wound-healing product for diabetic foot ulcers or other nitric-oxide-releasing drug. <br/><br/>The broader/commercial impacts of this project will be the potential to provide a new standard of care for the treatment of diabetic foot ulcers. Currently, there are no products that address both wound healing and infection in diabetic foot ulcers. Infection is particularly problematic in diabetic foot ulcers due to the lack of normal skin barrier function, long duration of wound exposure to the external environment (months to years), poor blood circulation to the extremities that limits the migration of inflammatory cells to the site of infection, and the recent understanding of biofilm formation which protects bacteria from topically applied antimicrobials and systemically administered antibiotics. Nitric-oxide-releasing wound-healing therapeutics have the potential of addressing both infection and healing in diabetic foot ulcers.

  • Program Officer
    Rajesh Mehta
  • Min Amd Letter Date
    10/24/2011 - 13 years ago
  • Max Amd Letter Date
    12/18/2013 - 10 years ago
  • ARRA Amount

Institutions

  • Name
    Novan, Inc.
  • City
    Durham
  • State
    NC
  • Country
    United States
  • Address
    4222 Emperor Blvd
  • Postal Code
    277038030
  • Phone Number
    9194858080

Investigators

  • First Name
    Nathan
  • Last Name
    Stasko
  • Email Address
    nstasko@novanonline.com
  • Start Date
    10/24/2011 12:00:00 AM

Program Element

  • Text
    SMALL BUSINESS PHASE II
  • Code
    5373

Program Reference

  • Text
    NANOMANUFACTURING
  • Text
    NANOTECHNOLOGY INITIATIVE
  • Code
    1084
  • Text
    SBIR Phase IIB
  • Text
    Nanomanufacturing
  • Code
    1788
  • Text
    SMALL BUSINESS PHASE II
  • Code
    5373