SOLICITATION NOTICE
A -- Radio-Synthesis of 11C-docetaxel.
- Notice Date
- 7/1/2008
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1043416-1
- Point of Contact
- Vida - Niles, Phone: 301-827-2476
- E-Mail Address
-
vida.niles@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- The Food and Drug Administration(FDA) is seeking full and open competition for vendors capable of providing service for a project titled: Radio-Synthesis of 11C-docetaxel. The Laboratory of Clinical Pharmacology at FDA has developed a micro-synthesis using CO2 as the donor to form the tert-butylcarbonate group on the side chain connected to the main Baccatin moiety. 11C-CO2 is a common cyclotron product that can be used with this method to generate 11C-docetaxel. The contractor must have access to a cyclotron and have sufficient experience in 11C production and synthetic chemistry to generate the 11C starting material and 11C-docetaxel final product. Request for Quotes - Statement of Work Reference # 1043416 The contractor shall furnish the necessary personnel, services, materials, and otherwise perform all necessary functions, in the performance of the work as described below. The primary amine form of precursor is available from the Laboratory of Clinical Pharmacology at the FDA. I.Work closely with the project officer and study liaison throughout the lifespan of the contract. II.The contractor shall synthesize 11C-docetaxel based on the procedure developed by the Laboratory of Clinical Pharmacology (LCP) at FDA. a.The contractor will perform the synthesis of 11C-docetaxel following the procedure developed by LCP. The procedure uses 11CO2 mixed with potassium tert-butoxide followed by the addition of methanesulfonyl chloride to produce 11C-di-tert-butyl dicarbonate (diBOC). The docetaxel precursor is reacted to complete the synthesis 11C-docetaxel. b.The contractor shall follow alternate synthesis methods of 11C-docetaxel from published literature or developed at their site to compare with the procedure described in 2a. The radiolabeled carbon may be in the form of 11CO2 or other forms of 11C. The synthetic process that is most facile with the least steps or shortest synthesis time and yields the most 11C-docetaxel will be used for isolation and purification steps suggested in 3 below. III.The contractor is required to purify the 11C-docetaxel after it is made. The suggestion is that the contractor follow procedure IIIa. IIIb allows the contractor to perform a different purification if the contractor so chooses. a.The reaction mix from 2a or 2b is dried and then dissolved in a small volume of 40% ethyl alcohol. It is passed through a strong cation solid phase exchange column (SPE) followed by more 40% ethyl alcohol. The pooled elutions are diluted with water and passed through a C18 SPE, washed with water, and eluted with MeOH. The MeOH elution containing the 11C-docetaxel is dried and a final purification step is performed by peak collection from HPLC. b.The contractor shall develop and follow alternate purification methods of the reaction mix from 2a or 2b. IV.The contractor shall optimize the full procedure from isotope generation to final injectable product while maintaining records of failed attempts and successful improvements. The contractor shall show that a sufficient quantity of final product can be produced with a specific activity and product quality required for patient imaging. Period of Performance: The FDA anticipates a one year period of performance from the time of award. Deliverables: The contractor shall issue monthly status reports to the project officer and study liaison indicating the progress since the last report. Due at the end of each month. At the completion of the project the contractor shall provide – I.Standard Operating Procedures (SOP) for the complete optimized production, synthesis, and purification processes under the Scope of Work above. Due 30 days after the completion of the project. II.Final report to include a summation of the results of the monthly reports and conclusions drawn from the findings. Due 30 days after the completion of the project. III. Reports shall be submitted in wordformat electronically via email upon due date. Evaluation criteria:100 Points The vendors should note that the evaluation criteria serve as the standard against which all technical information will be evaluated, and serve to identify the significant matters which vendors should address. I.Regular access to 11C Scoring will be base on the availability of 11C for repeated attempts at at synthesis and purification of 11C-docetaxel. 30 Points II.Experience in multistep radiosynthesis with 11C Scoring will be based on the experience of the contractor in performing multistep radiosynthesis with 11C. 50 Points III.Potential for clinical collaboration with Oncology Unit. 11C-Docetaxel will eventually be imaged in oncology patients as part of another study. Ideally the radiosynthesis of 11C-docetaxel for the oncology study will be performed in the same radiochemistry lab that the initial synthesis was performed. Scoring this element will be based on the potential for collaboration with a unit that can provide oncology patients for imaging studies. 20 Points THIS IS A REQUEST FOR QUOTES (RFQ). This announcement constitutes the only solicitation and a written solicitation will not be issued. QUESTIONS DEADLINE: all questions must be received by email (vida.niles@fda.hhs.gov) before 10:00 AM EST on July 7, 2008. All responsible sources must be registered in the Central Contractor Registry System (CCR) at www.ccr.gov to be considered. FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email and received by 10:00 AM EST on July 16, 2008 to the attention of Vida Niles, Vida.Niles@fda.hhs.gov. Evaluation/Award will be based on the technically acceptable quote that offers the best value to the Government. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures. No Phone Calls will be accepted.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=3a7a97d3f1332e5c08b28d1c6f3c5e9c&tab=core&_cview=1)
- Place of Performance
- Address: Contractor's origin, United States
- Record
- SN01605406-W 20080703/080701222653-3a7a97d3f1332e5c08b28d1c6f3c5e9c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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