SOLICITATION NOTICE
A -- Assay for Radiation Countermeasures - Provisions and Clauses
- Notice Date
- 4/3/2014
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Other Defense Agencies, Uniformed Services University of the Health Sciences, UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES (USUHS), 4301 JONES BRIDGE ROAD, Bethesda, Maryland, 20814-4799, United States
- ZIP Code
- 20814-4799
- Solicitation Number
- HU0001-14-Q-0380
- Archive Date
- 5/3/2014
- Point of Contact
- Steve H. Beck, Phone: 301-295-3970
- E-Mail Address
-
Steven.Beck@usuhs.mil
(Steven.Beck@usuhs.mil)
- Small Business Set-Aside
- N/A
- Description
- Provisions and Clauses The Uniformed Services University of the Health Sciences (USUHS) is the Nation's federal health sciences university and is committed to excellence in military medicine and public health during peace and war. We provide the Nation with health professionals dedicated to career service in the Department of Defense and the United States Public Health Service and with scientists who serve the common good. We serve the uniformed services and the Nation as an outstanding academic health sciences center with a worldwide perspective for education, research, service, and consultation; we are unique in relating these activities to military medicine, disaster medicine, and military medical readiness. USUHS is located in Bethesda, MD on the campus of Naval Support Activity Bethesda. Additional information regarding USU can be found on our website: www.usuhs.mil. We require a vendor to develop an ELISA (enzyme-linked immunosorbent assay) to detect the peptide, ALXN41000TPO in non-human primates. We required a vendor to improve and increase the sensitivity of the assay for the drug ALXN4100TPO. This is a combined synopsis/solicitation for commercial items in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This is a request for quotes (RFQ) for commercial items in accordance with the procedures of FAR Part 12 - Acquisition of Commercial Items and FAR Part 13 - Simplified Acquisition Procedures. This RFQ incorporates all provisions and clauses in effect through Federal Acquisition Circular (FAC) 05-72 (January 30, 2014) and Defense Federal Acquisition Regulation Supplement (DFARS) (March 31, 2014). This is an unrestricted requirement under NAICS code 541712 Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology), with a size standard of 500 employees. Offerors must be registered in the Systems for Awards Management (SAM - ww.SAM.gov), prior to award.   Background: The current assay system used to detect TPO mimetic is an ELISA employing sheep anti-human kappa light chain and sheep anti-human IgG. This assay system is being used to measure TPO in mimetic in mice. The methodology contains the following steps: Step 1: Coat ELISA plate with sheep anti-human kappa light chain antibody Step 2: Add mouse serum containing TPO mimetic and wash Step 3: Add sheep anti-human IgGconjugated to color developing enzyme Problem: Non-human primates are used in the detection of human clinical therapeutic agents. Increasingly such therapeutic agents are either humanized immunoglobulins directed to host antigens or small peptides conjugated to human immunoglobulins. Unfortunately, due to considerable similarity in the primary, secondary and tertiary structures of human immunoglobulins to monkey immunoglobulins (IgG), differential detection of these entities become technical challenges. In the context of the current need to detect ALXN4100TPO in the pre-clinical trial using monkeys, a similar situation is encountered. When monkey serum containing ALXN4100TPO is added to the ELISA plate coated with sheep anti-human IgG, together with ALXN4100TPO, monkey IgG will also bind to the sheep IgG. This is because monkey IgG cross reacts with sheep IgGs. This results in excessive non-specific binding of the second antibody to this complex and a spuriously high signal. Requirement: We require a vendor to develop a new ELISA (enzyme-linked immunosorbent assay) to detect the peptide, ALXN41000TPO in non-human primates. We required a vendor to maximize the sensitivity of the assay for the drug ALXN4100TPO. Deliverables: CLIN 0001 Provide a detailed technical report (to include experimental details such as reagents, methodology, results, validation procedure*) *validation of the assay will be carried out in the conventional way acceptable for peer reviewed publication of the results. Prepare sufficient quantities of improved testing reagent (polyclonal antibody) which will be used for testing 100+ samples Required Delivery Date for CLINs 0001 is August 29, 2014. Earlier delivery (at no additional cost to the Government), is desirable. Optional Requirement: CLIN 0002 After the principal investigator analyzes the report, he may require (Government Option), the vendor to analyze the samples using the improved test reagents. The vendor will be required to use standard ELISA with proper positive and negative controls. Upon award, the Government will provide the awardee with Government Furnished Material to include: • ALX4100TP0 (approx 200 mg - sufficient amount to perform our requirement) • Untreated pooled nonhuman serum samples (approx 4-5 ml) • Antibody scaffold (approx 500 mg) The vendor must provide results and methodological interpretation of the results in an appropriate format. The information is due 30 days after the Government orders the samples. Restriction: ALXN41000TPO was developed by Alexion Pharmaceuticals. The drug company no longer makes this product. USUHS has a very limited supply of this compound and will only provide it to the awardee. Prior to award, the vendor MUST sign a non-disclosure agreement as a condition of confidentiality of the work. The government intends to award a single firm-fixed priced (FFP) contract to the vendor who offers the best value to the government based on the evaluation factors listed below. Evaluation factors are listed in order of importance, with most important listed first. The government will conduct a trade-off between price and non-price factors. The Government is not required to award to the lowest priced offeror or the offeror quoting the highest technically rated solution. The government reserves the right to award without discussions. Evaluation Factors (listed in order of importance): 1. Corporate Experience - Have high level of expertise in immunological techniques; must have worked with peptides, must have worked with ELISA, must be familiar with hematopoiesis, and must have worked with injury models that result in partial or full loss of blood cells. Information on projects within the last three year involving work similar to our requirement, or productivity as evidenced by papers published in peer- reviewed journals, and extramural grant support are examples of past outstanding performance 2. Price - Offerors must include all applicable costs (to include shipping) in their quote - to include the Option CLIN Offerors must submit the following with their quote: • Completed copy of provision 252.209-7999, and DFARs Provision 252.209-7993. • See attached list for applicable provisions and clauses for this requirement. All questions must be e-mailed to Mr. Steve Beck at steven.beck@usuhs.mil, AND received by Mr. Beck no later than 10am, April 8, 2014 Quotes will not be accepted by any other means. Late quotes will not be considered. All quotes must be e-mailed to Mr. Steve Beck at steven.beck@usuhs.mil, AND received by Mr. Beck no later than 3pm, April 18, 2014. Quote packages should include a cover sheet that provides the following information: • Company Name • Point of Contact to include e-mail and phone number • DUNS number • Statement that includes of acknowledgement of latest amendment number (if applicable) • List of applicable experience • Brief discussion of technical approach • Proposed Prices o CLIN 0001 - development of valid technique and sufficient quantities of improved testing reagent o CLIN 0002 - analyze the samples using the improved test reagents. The vendor must provide results and methodological interpretation of the results in an appropriate format.
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