SOLICITATION NOTICE
Q -- Detection of mutation-reactive T cells in patients with metastatic cancers
- Notice Date
- 4/14/2015
- Notice Type
- Presolicitation
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02RC52566-83
- Archive Date
- 5/14/2015
- Point of Contact
- Gwennifer K. Epps, Phone: 240-276-5445, Terry Galloway, Phone: 240-276-5384
- E-Mail Address
-
eppsg@mail.nih.gov, gallowaytl@mail.nih.gov
(eppsg@mail.nih.gov, gallowaytl@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Surgery Branch (SB), on a sole source basis plans to purchase custom made peptides, custom made gene synthesis, and cloning for up to 50 patients with cancer from GenScript USA Inc., 860 Centennial Ave., Piscataway, NJ 08854, USA. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1 (b)(2) and 13.501-(a)(1) using simplified acquisition procedures for commercial acquisitions. The Government contemplates only one award and will be made as a result of this solicitation. This will be awarded as a firm fixed price, Indefinite Delivery Indefinite Quantity (IDIQ) type contract. The period of performance of the IDIQ contract is eighteen (18) months from date of award. The Associated North America Industry Classification Code (NAICS) 621511 and the Business Size Standard is $32 million. It has been determined there are no opportunities to acquire green products or services for this procurement. The Surgery Branch (SB), of the National Cancer Institute is a combined laboratory and clinical research unit devoted to the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer. Efforts run the gamut from basic studies of cancer immunology to the conduct of clinical immunotherapy trials for patients with metastatic cancer. One of the SB current major therapeutic strategies is to use tumor mutation-reactive T cells to treat patients with cancer. This is based on data from NCI clinical trials demonstrating that the curative responses seen in patients with melanoma treated with T cells are likely mediated by mutation-reactive T cells. Moreover, the SB of the NCI recently treated a patient with metastatic bile duct cancer with a highly pure population of mutation-reactive T cells and are observing ongoing tumor regression at 16+ months after therapy. Thus, the Surgery Branch is attempting to treat more patients with mutation-reactive T cells. However, in order to do this, the SB first has to identify mutation-reactive T cells from patients. The reagents required to identify mutation-reactive T cells are custom genes and custom peptides that encode for tumor mutations. The SB will use these reagents in "real time" to develop therapies to treat patients with late stage cancer, and will require that these reagents be synthesized quickly, be error-free and that the product sequences are of high quality. In addition, the SB will require custom made gene synthesis and cloning, and custom made peptides in a timely manner. Thus, to conduct this research, CI/SB intends to sole source with GenScript. GenScript is a pioneering DNA synthesis company and is the largest gene synthesis supplier in Unites States. The company has advanced molecular biology facilities with over 20,000 square feet of working area; and, has synthesized over 500,000 genes and constructs. Over the years, GenScript developed and uses its Gene-on-Demand® technology platform, which brings together proprietary OptimumGene TM codon optimization technology and CloneEZ® seamless cloning technology for the synthesis of GC-rich and extremely long genes. This has allowed GenScript to synthesize and clone challenging genes into any vector. The unique qualities provided by GenScipt is relevant to the NCI, as the genes that the SB require are truly unique and can be highly diverse and potentially complicated. GenScript has a large gene synthesis capacity (over 7.5 million bp/month) and proprietary technologies which enables the company to deliver custom de novo genes of any length and any complexity. In addition to gene synthesis, GenScript provides high-quality peptide synthesis service with a 95% peptide synthesis success rate, which is well above the industry standard of 75%. GenScript is committed to Total Quality Management (TQM) which includes MS and HPLC analyses performed after the completion of peptide synthesis, purification, and QC (quality control) steps. These analyses are followed by independent QA (quality assurance) procedures, which double guarantee the highest quality possible for every delivered peptide. GenScript is capable of producing over 6000 peptides per month, and the peptides can be in mg to kg quantities of varying purity. NCI feels that GenScript is the best contractor that can fulfill the all requirements of this procurement in a cost effective and timely manner. Also, the company has the capacity to do both gene synthesis and peptide synthesis. Lastly, GenScript is the company providing the SB custom made peptides, custom made gene synthesis, and cloning. Purchasing reagents from another company would be disruptive to both the science and clinical trials. This is not a solicitation for competitive quotations. However, if any interested party especially a small business, believes they can meet the above requirement, they must submit a statement of capabilities and quote. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. An original and one copy of the capability statement and quote must be received in the NCI Office of Acquisitions on or before 11:00 AM EST on, April 29, 2015. Electronic capability statements and quotes will be accepted (i.e. email or fax); an original and one copy must be sent to the NCI Office of Acquisitions at the address stated above. All questions must be in writing and can be faxed (240) 276-5401 or emailed to Gwennifer Epps, Contracting Officer at ge50d@nih.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must have valid registration and certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA), through sam.gov. No collect calls will be accepted. Please reference solicitation number N02RC52566-83 on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02RC52566-83 /listing.html)
- Place of Performance
- Address: National Cancer Institute, National Institutes of Health, Bethesda, Maryland, 20814, United States
- Zip Code: 20814
- Zip Code: 20814
- Record
- SN03698941-W 20150416/150414235243-ca9aefce3533ae322f01462ecff2c60e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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