SOLICITATION NOTICE
Q -- N02RC42637-24
- Notice Date
- 8/21/2014
- 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
- N02RC42637-24
- Archive Date
- 9/12/2014
- Point of Contact
- Kimesha Leake, Phone: 2402765669, Terry Galloway, Phone: 240-276-5384
- E-Mail Address
-
kimesha.leake@nih.gov, gallowaytl@mail.nih.gov
(kimesha.leake@nih.gov, gallowaytl@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Center for Cancer Research (CCR), Genitourinary Malignancies Branch (GMB) plans to procure on a sole source basis services to create a custom rabbit monoclonal antibody against adrenocorticoropic hormone (henceforth known as ACTH) from ImmunoPrecise Antibodies Ltd, Unit 3204-4464 Markham Street, Victoria, B.C. V8Z 7X8, Canada. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(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 500 employees. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The period of performance is 6 months from date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. The Genitourinary Malignancies Branch (GMB) focuses on investigating the biology of genitourinary cancers, developing new strategies for treating those cancers, and evaluating these new therapeutic approaches through science-driven clinical research. These clinical trials investigate novel approaches in immunotherapy, hormonal therapy, chemotherapy combinations, and small-molecule targeted therapy. The current requirement of the GMB is for ACTH Custom Rabbit Monoclonal Aby Synthesis. A 15-20 amino acid sequence corresponding to a segment of ACTH will be provided to the contractor. The contractor will then generate a peptide that will be used when immunizing the rabbits. In the process of immunization, the contractor will immunize two rabbits with an initial dose of the ACTH peptide. After the initial dosage, there will be two booster shots, a bleed to check for antibodies, another boost, and the rabbit with the highest titer, or concentration, of antibody will be sacrificed. From this rabbit, approximately 4000 peripheral blood mononuclear cells, (PBMCs), will be isolated and cultured to a volume of approximately 100 μL in 40  96 well plates. At this stage, the contractor is able to provide supernatant for the purchaser to test. However, the volume and concentration are both low (20 μL at a concentration of approximately 10 ng/mL). Following the culture, an indirect ELISA will be conducted to assess the binding specificity of the antibodies. From which, the NCI will select 32 PBMCs to grow further. These PBMCs once cultured to an adequate volume, then have their mRNA extracted, cDNA created from the resulting mRNA, and the heavy and light chains of the antibodies generated by PCR. These heavy and light chains are then cloned and expressed together using transient transfection. These resulting antibodies will again be tested by an indirect ELISA experiment and the NCI will select up to 5 recombinant antibodies. At this stage, the contractor shall supply up to 4 mL for testing at approximately 10-100 μg/mL for the NCI to test. Finally, the DNA sequence is retrieved from the chosen recombinants and used to generate larger volumes as well as concentrations. The project consists of: 1) Production of peptide to be immunized against - 3-4 weeks 2) Immunization phase: Initial immunization, 2 boosts, test bleed after 2nd boost, 3rd boost, sacrifice rabbit with highest titre - 78 days 3) Isolate PBMCs and culture approx. 4000 individual PBMCs - 1-2 weeks 4) Screen PBMCs - 1 week 5) Select up to 32 top PBMCs, isolate mRNA, convert to cDNA, PCR amplify heavy & light chains, clone into expression plasmid - 2-3 weeks 6) Transient transfection of up to 32 cloned recombinant antibodies & screening of culture S/Ns - 2 weeks 7) Expression and purification of 10mg of antibody for 2-3 best recombinants - 2 weeks. Turnaround time is approximately 6 months. Personnel shall have the education, training, and experience, or any combination thereof, to enable them to perform their assigned functions. ImmunoPrecise Antibodies Ltd. (IPA) is unique because of its ability to produce large quantities (40 mg) of the ACTH antibody requested which is the volume that will be needed for future rabbit experiments. The NCI is hopeful that the use of this aby will be successful at targeting the animal's adrenal gland. If animal experiments prove successful, the NCI would eventually want to produce this antibody for human use. In addition, IPA provides the customer with full intellectual property and rights over the created antibody as well as the sequence for the antibody. Other companies are known to charge large fees for initial commercialization as well as royalties on the future sale and or production of said antibody. Thus IPA is the only known vendor to satisfy the current need. This notice is not a request for competitive quotation. However, if any interested party, 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 4:00 PM EST, on August 28, 2014. All responses and questions must be in writing and faxed 240-276-5401 or emailed to Kimesha Leake, Contract Specialist via electronic mail at Kimesha.leake@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 System for Award Management (SAM) through sam.gov. Reference: N02RC42637-24 on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02RC42637-24/listing.html)
- Record
- SN03475876-W 20140823/140822000722-73be4ead72185d666825c28d21d3d938 (fbodaily.com)
- Source
-
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