Manufacturing of GMP-ready iPSCs and Derived RPE from Patients with AMD to be Used in Pre-clinical Studies for an IND
The National Eye Institute (NEI) of the National Institutes of Health (NIH) has a requirement for the generation of Good Manufacturing Practice (GMP) grade induced pluripotent stem cell (iPSC) lines from skin and blood samples collected from patients with age-related macular degenerative disease; optimization of the retinal pigment epithelium differentiation process from iPSC lines PSC-RPE process; and the manufacture GMP grade RPE cells.
This is a Small Business SOURCES SOUGHT NOTICE to determine the availability of potential small businesses (e.g., 8(a), Veteran-owned Small Business, Service-disabled Veteran-owned Small Business, HUBZone Small Business, Small Disadvantaged Business, and Woman-owned Small Business) to provide GMP grade iPSC lines from skin and blood samples collected from patients with age-related macular degenerative disease; optimization of the retinal pigment epithelium differentiation process from iPSC lines PSC-RPE process; and the manufacture GMP grade RPE cells.
The anticipated period of performance is August 1, 2014 through July 31, 2015. The anticipated contract will comprise one (1), one-year base period and one (1), one-year option period which may be exercised unilaterally by the Government for a potential period of performance of 24 months.
This is not a request for proposals, proposal abstracts, or quotations and does not commit the Government to any contractual agreement.
Interested organizations that believe they possess the capabilities necessary to undertake this project should electronically submit (email) capability statements tailored to be responsive to the requirement described above. Capability statements shall be in PDF format. The contents of the capability statement shall be limited to fifteen (15), 8.5x11 size pages with no less than 11 font Arial characters, no less than one inch margins and no less than single spaced. Capability statements exceeding the page limitation will not be considered. Capability statements should be submitted to [email protected] no later than Friday, June 20, 2014, 5:00 P.M., EST.
Respondents will not be notified of the results of the evaluation. Information received will be considered solely for the purpose of determining whether sufficient small businesses possess the experience, expertise, and qualifications to ensure competition under a set-aside acquisition. A determination by the Government not to compete this requirement as a set-aside based upon responses to this notice is solely within the discretion of the Government.
Louis A Kuta, Sr., Phone 301-594-5782, Email [email protected] - Carolyn Keeseman, Phone 301-496-8504, Email [email protected]
