SOLICITATION NOTICE
B -- pRODUCTION OF CELL-MEMBRANE PERMEANT
- Notice Date
- 3/8/2011
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-CSB-(HL)-2011-109-DDC
- Archive Date
- 3/30/2011
- Point of Contact
- Deborah - Coulter, Phone: (301) 435-0368
- E-Mail Address
-
dc143b@nih.gov
(dc143b@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The COAC Services Branch, Office of Acquisitions, DERA, National Heart, Lung, and Blood Institute (NHLBI), NIH, for the Laboratory of Molecular Cardiology (LMC), Genetics and Developmental Biology Center (GDBC), Division of Intramural Research, NHLB intends to negotiate and award a purchase order on a noncompetitive sole source basis to RetroTherapy LLC, 9430 Key West Avenue, Rockville, MD 20850, for the development and production of cell-membrane permeant Oct4, Nanog, and Sox2 bioactive proteins for the reprogramming of human somatic cells into iPS cells. The reference number: NHLBI-CSB-(HL)-2011-109-DDC. The Government requires the development and production of cell-membrane permeant Oct4, Nanog, and Sox2 bioactive proteins for the reprogramming of human somatic cells into iPS cells; as outlined in the statement of work. Background: The use of inducible pluripoten stem (iPS) cells for both research and possible future therapeutic interventions is presently restricted by 2 major obstacles: 1. The first is the only well established method by which human somatic cells can be reprogrammed into iPS cells, that is, the use of forced expression of all or combinations of special transcription factors: (Oct4, Sox2, Klf4, c-Myc (OSKM)) and Nanog proteins in the somatic cell targets. 2. The second is the difficulty in obtaining pure populations of the differentiated cells of interest. Due to the exogenous transcription factors are suppressed by epigenetic mechanisms within weeks, the transient use of purified protein factors directly capable of traversing the cell membranes would be a big step forward. This is because the integrated viral sequence from the viral based gene transduction leaves open the possibility of future mutagenesis. Furthermore, the suppressed exogenous viral integrants reduce the fidelity of the iPS cells compared to embryonic stem cells (ES). Unfortunately, researchers to date have not been able to produce these factors in bioactive forms in amounts required for this technique to either be practical or even demonstrable. Identify the purpose and list the specific objectives of the service: To generate one milligram of Oct4, Sox2, Klf4 and Nanog proteins using both a baculoviral based system and E. coli based system. The latter must employ a refolding protocol using FPLC. Contractor Requirements: The contractor must have broad and deep knowledge of protein chemistry including the use of FPLC. The contractor is required to complete the following tasks: a. To generate the constructs expressing Oct4, Sox2, Klf4, and Nanog proteins for both E. coli. and baculoviral based expression systems. b. To use these constructs in E. coli to generate the factors, extract them in 8M urea and refold them using a multichannel FPLC machine. c. To use the baculaviral based constructs in a baculoviral expression system to produce these proteins as soluble factors which do not require refolding. d. To attach a 9 aminoacid TAT sequence to the N-terminal or C-terminal end of the constructs to make the transcription factors cell-membrane permeable. e. To assist in the use of these factors to generate iPS cells from human CD34+ cells. Government Responsibilities: The government will consult with the contractor and oversee the construction of the various vectors and assist in the production of the proteins. The government will also use the proteins to generate the human iPS cells under cell culture conditions. Deliverables and Reporting Requirements: The proteins which are produced according to a variable schedule based on laboratory results in generating the iPS cells will be delivered at least once and up to 4 times a month. The government will review the Quality Assurance Data for each batch of proteins including western blots, and assays for concentration and purity. The period of performance starts on/around April 1, 2011 through October 31, 2011 The sole source determination is based on the fact that the LMC, GDBC has developed several protocols that have significantly improved the ability to generate bioactive forms of these cell-membrane permeable transcription factors in relatively large amounts. This requirement involves the sophisticated use of a multi-channel Fast Liquid Chromatography (FPLC) machine and very advanced protocols for growing difficult to express proteins in a baculoviral based system. RetroTheraphy LLC, has the knowledge and expertise with this novel used of a multi-channel FPLC to refold insoluble proteins into bioactive proteins. This process was first developed in LMC, GDBC with the collaboration of RetroTherapy LLC. Therefore, it is in the Government's best interest to continue to use the services of RetroTherapy LLC to prevent disruption in the Government's research. The delivery point is the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), 10 Center Drive, Building 10-Room 7N220, Bethesda, Maryland 20892. The notice of intent is not a request for competitive proposals. Only one responsible source and no other supplies or services will satisfy agency requirements. Industry Classification (NAICS) Code is 541711, Research and Development in Biotechnology with size standard of 500 employees; the small business set-aside does apply for this requirement. The acquisition is being conducted under FAR Part 13, simplified acquisition procedures, therefore the requirements of FAR Part 6 B Competitive Requirements are not applicable (FAR Part 6.001) and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-48 (January 31, 2011). This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this synopsis, by March 15, 2011, 7:30 am Eastern Standard Time. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct future competitive procurement. Inquires to this announcement, referencing synopsis number NHLBI-CSB-(HL)-2011-109-DDC, may be submitted to the National Heart, Lung and Blood Institute, Office of Acquisition, Procurement Branch, 6701 Rockledge Drive, Suite 6042, Bethesda, Maryland 20892-7902, Attention: Deborah Coulter. Response may be submitted electronically to coulterd@nhlbi.nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-(HL)-2011-109-DDC/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02396064-W 20110310/110308234558-35d71926634d14cedac6e333796f7a0f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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