SOLICITATION NOTICE
65 -- Production of clinical-grade gamma-retrovirus vector encoding an anti-CD319 chimeric antigen receptor
- Notice Date
- 4/6/2017
- Notice Type
- Presolicitation
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- 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
- N02RC72536-88
- Archive Date
- 5/6/2017
- Point of Contact
- Chad M. Shearer, Phone: 2402766801
- E-Mail Address
-
chad.shearer@nih.gov
(chad.shearer@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- General Information Short Title: Production of clinical-grade gamma-retrovirus vector encoding an anti-CD319 chimeric antigen receptor Solicitation Number: N02RC72536-88 Posted Date: 4/6/2017 Response Date: 4/21/2017 Classification Code: 6505 - Drugs and Biomedicals NAICS Code: 325414 - Biological Product (except Diagnostic) Manufacturing Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E638, Bethesda, MD 20892, UNITED STATES Description National Cancer Institute (NCI), Center for Cancer Research (CCR), plans to procure on a sole source basis products related to clinical-grade gamma-retrovirus vector encoding an anti-CD319 chimeric antigen receptor from the Vector Production Facility, Translational Core Laboratories, Cincinnati Children's Hospital, 3333 Burnet Av. S11.400, MLC 7013, Cincinnati, OH 45229. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR 13.106-1(b)(1) and FAR 13.501-(a)(1) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 325414 and the business size standard is 1,250 employees. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. Delivery will be made by December 1st, 2017. It has been determined there are no opportunities to acquire green products or services for this procurement. The CCR is the largest division of the NCI intramural research program and comprises nearly 250 basic and clinical research groups located on two campuses outside of Washington DC. The CCR is home to an extraordinary group of scientists and clinicians exploring the cutting-edge of cancer and HIV/AIDS research. Our scientists work on a wide spectrum of biological and biomedical problems ranging from visualizing and understanding the structure of individual genes and proteins, developing novel methods for drug discovery, to inventing biomedical devices and technology and creating innovative ways to treat patients in the NIH Clinical Center. Chimeric antigen receptors (CARs) are fusion proteins containing antigen-recognition domains and T-cell activation domains. When T cells are genetically modified to express CARs, they gain the ability to specifically recognize an antigen and to kill cells expressing the antigen. In previous clinical trials, CAR-expressing T cells have been shown to have potent anti-malignancy activity against leukemia and lymphoma. In particular, CARs targeting CD19 have been shown to be effective in multiple clinical trials, but extension of CAR T-cell therapies to other malignancies has not yet been widespread. We have designed and constructed a CAR targeting CD319. This CAR is encoded by a gamma-retroviral vector. We plan to use this transiently-produced gamma-retroviral gene-therapy vector that is the subject of this JOFOCT to genetically modify T cells from patients with multiple myeloma. Multiple myeloma cells express CD319. We will use the T cells genetically modified to express the anti-CD319 CAR to treat patients with multiple myeloma. Contractor shall produce 20 liters of clinical-grade gamma-retroviral gene-therapy vector for use in a clinical trial. This gamma-retroviral gene-therapy vector will be produced by the transient transfection method, and the vector must be completed by the end of 2017. The vector will encode a chimeric antigen receptor (CAR) recognizing a multiple myeloma antigen. The intended use of this vector is to transduce patient T cells. These T cells will be administered as a treatment for multiple myeloma in a clinical trial. The vector will be gibbon ape leukemia virus (GALV) pseudotyped. The vector will be generated in 293T cells. The contractor will provide packaging plasmids. The NCI will provide a plasmid encoding the CAR also known as the expression construct. This contract includes full testing of the vector to satisfy requirements for clinical use including testing for replication-competent retroviruses (RCR), testing for mycoplasma, syroplasma, endotoxin, adventitious virus, residual plasmid DNA, residual cellular DNA, transfer of E1A sequences, transfer of SV40 sequences, and testing for bacterial sterility. The contractor must provide documentation of vector test results for inclusion in applications to the Food and Drug Administration. The produced vector must be able to transduce primary human T cells to a degree that at least 20% of primary human T cells will express the chimeric antigen receptor gene on the T-cell surface as measured by flow cytometry. Shipment of the gamma-retroviral vector from the site of production to a storage site is not included in this contract, but temporary storage of the vector for up to 6 months is included. This notice is not a request for competitive quotation. However, if any responsible source, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 3:00 PM EST, on April 21, 2017. All responses and questions must be in writing and faxed 240-276-5401or emailed to Chad Shearer, Contract Specialist, via electronic mail at chad.shearer@nih.gov. A determination by the Government not to compete this proposed requirement 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. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the Central Contractor Registration and the Online Representations and Certifications Applications through the System for Awards Management website (sam.gov). Reference: N02RC72536-88 on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02RC72536-88/listing.html)
- Place of Performance
- Address: Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04463642-W 20170408/170406235846-c28be9dd343410e64986b12d3a44b505 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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