HUMAN FIBROBLAST IN VITRO

SOURCES SOUGHT NOTICE The Uniformed Services University of the Health Sciences (USUHS), located on the Walter Reed National Military Medical Center (WRNMMC), Bethesda, MD, has a potential requirement to expand human fibroblasts in vitro for re-introduction into human subjects. This is not a pre-solicitation notice and should not constitute as a Request for Proposals, Request for Quotations; nor construed as a commitment by the Government of any future action. The purpose of this sources sought notice is to seek feedback from the industry that identifies multiple sources, find interested vendors to foster competition, and to prepare the appropriate acquisition decision about soliciting this requirement as either a competitive set-aside or full and open; or proceed as negotiated sole source procurement. The Government is seeking firms relative to the North American Industry Classification Code (NAICS) 541380 - Testing Laboratories with a size standard of $12.0 million of dollars 541690 - Other Scientific and Technical Consulting Services with a size standard of $7.0 millions of dollars 541712 - Research and Development in the Physical, Engineering, and Life Sciences with a size standard of 500 employee The Government has generated a protocol to expand human fibroblasts in vitro for re-introduction into humans. This protocol is specific for an autologous fibroblast product and is being developed under an open Investigational New Drug Application with the Food and Drug Administration. The protocol has been generated and all reagents and processes have been optimized and reviewed. The Government will supply the vendor with the harvested human donor skin. The vendor will expand the fibroblasts for the harvested human skin in a Good Laboratory Practice or Good Manufacturing Practice facility that meets the requirements of the FDA outlined in the pre-IND meeting. The expanded cells will need to be free of adventitial agents, sterile, and pure as outlined in the pre-IND materials. The cells will then be provided to the Army for autologous re-introduction into healthy donors. The contract will require the vendor to demonstrate that they can expand the fibroblasts according to an established protocol. This initial task must be accomplished over a 90-day period. Upon review of the work performed during the initial 90-day period, the vendor will submit an estimate to generate the product on a per-lot basis. Upon satisfactory review of the initial material, the vendor will generate the product on a per-lot basis over the remaining 365 days. The anticipated number of lots required is 10. The Government is seeking commercial services to provide the following: 1) The vendor will use available human fibroblasts from either an adult donor or fetal foreskin to demonstrate that the existing protocol documentation is adequate to expand the fibroblasts as outlined in the draft Chemistry Manufacturing and Controls section of the draft IND. 2) The vendor will provide the data from this initial expansion to the Government for incorporation into the final IND submission provided to the FDA. The Government will retain all cellular material and data from this initial expansion to include all remaining expanded fibroblasts. 3) The vendor will determine a per-sample fee for expansion of fibroblasts from skin biopsies to include transport of the skin biopsy specimen to the vendor's lab, expansion of the fibroblasts, testing of the fibroblasts for sterility and purity, placement in a proprietary freezing media, and transport back to the Government for grafting into the autologous donor. 4) The vendor will expand fibroblasts from a 4 mm skin biopsy as directed by the Government for ongoing studies. 5) Optional assays that the vendor could perform include quantitative RT-PCR studies on skin samples from the donor, routine hemotoxylin and eosin staining, and immunostaining of donor skin tissue, in-vitro cell-culture assays to assess expression of specific skin markers. THE FOLLOWING INFORMATION IS REQUIRED: 1. Name of firm with address, phone number, fax number, e-mail address, and point of contact. 2. State if your company is a Hubzone Small Business, or Service-Disabled Veteran-Owned Small Business, Women-owned small business, Small Disadvantaged business, and 8(a). 3. Qualifications: Responses to this sources sought synopsis shall indicate specialized experience in expanding human fibroblasts in vitro. 4. Submission Requirements: Firms submitting responses shall present their information in a matrix format showing relevant contracts that are similar in scope that they have performed. The matrix shall show the most recent, up to five projects, that prove you can meet each qualification criteria listed above with contract number, project location, description of work requirements, contact and phone number for each effort, etc. Direct any questions or inquiries in writing by February 19, 2013 at 12:00 p.m. (EST), to Christina Johnson, Contract Specialist, via e-mail address, contact@example.gov, ATTN: HT9404-13-R-0022 HUMAN FIBROBLASTS IN VITRO. Questions will not be answered over the phone and questions submitted after the due date will not be addressed. If you can meet all of the requirements for this project, please respond to this sources sought notice by February 28, 2013 either by fax or e-mail to the attention of Ms. Christina Johnson, Contract Specialist, Fax: +1 (555) 000-0000 or e-mail at contact@example.gov, ATTN: HT9404-13-R- 0022. Responses must be received no later than 3:30 p.m. EST. **Respondents will not be notified of the results of the evaluation. Please visit the FBO website at www.fbo.gov for future contract opportunities.** OURCES SOUGHT NOTICE The Uniformed Services University of the Health Sciences (USUHS), located on the Walter Reed National Military Medical Center (WRNMMC), Bethesda, MD, has a potential requirement to expand human fibroblasts in vitro for re-introduction into human subjects. This is not a pre-solicitation notice and should not constitute as a Request for Proposals, Request for Quotations; nor construed as a commitment by the Government of any future action. The purpose of this sources sought notice is to seek feedback from the industry that identifies multiple sources, find interested vendors to foster competition, and to prepare the appropriate acquisition decision about soliciting this requirement as either a competitive set-aside or full and open; or proceed as negotiated sole source procurement. The Government is seeking firms relative to the North American Industry Classification Code (NAICS) 541380 - Testing Laboratories with a size standard of $12.0 million of dollars 541690 - Other Scientific and Technical Consulting Services with a size standard of $7.0 millions of dollars 541712 - Research and Development in the Physical, Engineering, and Life Sciences with a size standard of 500 employee The Government will supply the vendor with the harvested human donor skin. The vendor will expand the fibroblasts for the harvested human skin in a Good Laboratory Practice facility that meets the requirements of the United States Food and Drug Administration (FDA). The expanded cells will need to be free of adventitial agents, sterile, and pure as outlined in the pre-Investigational New Drug (IND) meeting. The expanded cells will need to be free of adventitial agents, sterile, and pure as outlined in the pre-IND materials. The cells will then be provided to the Government for autologous re-introduction into healthy human subjects. The Government is seeking commercial services to provide the following: 1) The vendor will use available human fibroblasts from an adult donor or fetal foreskin to demonstrate that the existing protocol documentation is adequate to expand the cells as outlined in the draft Chemistry Manufacturing and Controls section of the draft IND. 2) The vendor will provide the findings from this initial expansion as well as remaining expanded fibroblasts to the Government for incorporation into the final IND submission provided to the FDA. The Government will retain all cellular material and data from this initial expansion. 3) The vendor will determine a per-sample fee for expansion of fibroblasts from skin biopsies to include transport of the skin biopsy specimen to the vendor's lab, expansion of the fibroblasts, testing of the fibroblasts for sterility and purity, placement in a proprietary freezing media, and transport back to the Government for grafting into the autologous donor. 4) The vendor will expand fibroblasts from a 4 mm skin biopsy as directed by the Government for ongoing studies. 5) Optional assays that the vendor could perform include quantitative RT-PCR studies on skin samples from the donor, routine hemotoxylin and eosin staining, and immunostaining of donor skin tissue, in-vitro cell-culture assays to assess expression of specific skin markers. THE FOLLOWING INFORMATION IS REQUIRED: 1. Name of firm with address, phone number, fax number, e-mail address, and point of contact. 2. State if your company is a Hubzone Small Business, or Service-Disabled Veteran-Owned Small Business, Women-owned small business, Small Disadvantaged business, and 8(a). 3. Qualifications: Responses to this sources sought synopsis shall indicate specialized experience in expanding human fibroblasts in vitro. 4. Submission Requirements: Firms submitting responses shall present their information in a matrix format showing relevant contracts that are similar in scope that they have performed. The matrix shall show the most recent, up to five projects, that prove you can meet each qualification criteria listed above with contract number, project location, description of work requirements, contact and phone number for each effort, etc. Direct any questions or inquiries in writing by February 19, 2013 at 12:00 p.m. (EST), to Christina Johnson, Contract Specialist, via e-mail address, contact@example.gov, ATTN: HT9404-13-R-0022 HUMAN FIBROBLASTS IN VITRO. Questions will not be answered over the phone and questions submitted after the due date will not be addressed. If you can meet all of the requirements for this project, please respond to this sources sought notice by February 28, 2013 either by fax or e-mail to the attention of Ms. Christina Johnson, Contract Specialist, Fax: +1 (555) 000-0000 or e-mail at contact@example.gov, ATTN: HT9404-13-R- 0022. Responses must be received no later than 3:30 p.m. EST. **Respondents will not be notified of the results of the evaluation. Please visit the FBO website at www.fbo.gov for future contract opportunities.**