Production of Rabbit Monoclonal Antibodies Against Human CD22

This Amendment revises the Pre-Solicitation Notice. Changes to pre-solicitation are underlined. Responses to Questions submitted. Responses are in bold Due Date is extended to Monday 9, 2013. National Cancer Institute (NCI), Center for Cancer Research (CCR), Laboratory of Molecular Biology (LMB), Molecular Biology Section, plans to procure on a sole source basis services to generate 3 rabbit hybridomas with up to 9 hybridoma subclones to be chosen by NCI/LMB as a result of vendor screens from Epitomics, Inc. 863 Mitten Rd. Suite 103, Burlingame, CA 94010. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1). The North American Industry Classification System code is 541990 and the business size standard is $14.0 Million. 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 twelve (8) months from date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. NCI/CCR/LMB, is working on a second generation immunotoxin against CD22 and requires a (Rabbit) monoclonal antibody against a new epitope of CD22 for the backbone of the new immunotoxin. The antibodies will be used to make immunotoxins with very high affinity in order to understand the relationship between affinity and tumor response. Contractor Requirements are: Contractor shall generate 3 rabbit hybridomas with up to 9 hybridoma subclones to be chosen by NCI/LMB as a result of vendor screens. Phase I: Rabbit Polyclonal Antibody Service - Immunization of four (2) rabbits using standard immunization of five (5) injections and two (2) test bleeds per rabbit. - Monitor antiserum titer using standard ELISA - Monitor antiserum titer using cell ELISA - Discuss titer results with NCI to select rabbit for splenectomy - Final IV and splenectomy (Final IV must be scheduled within 4-8 weeks of last regular injection boost). Phase IIa: Rabbit Monoclonal Antibody Service - Isolate all the lymphocytes from one rabbit spleen. - Store all remaining lymphocytes in liquid nitrogen for up to three (3) months after the termination of the project. Phase IIb: Rabbit Monoclonal Antibody Service - Perform hybridoma fusion of 80 x 96-well plates. - Perform standard ELISA screening of 80 x 96-well plates. - Expand all positive hybridomas to 24-well plates and perform confirming standard ELISA and cell ELISA assay. - Epitope binning with ForteBio system on confirmed supernatant from above on up to 30 supernatants. - Affinity binding with ForteBio system on confirmed supernatant from above on up to 20 supernatants. - Transfer and deliver all standard ELISA positive multi-clone supernatants (1 ml each) for a two week screening by NCI. Phase IIIa: Rabbit Monoclonal Antibody Service - Subclone up to 3 hybridomas chosen by NCI. - For each hybridoma chosen, deliver supernatants (1 ml each) from 10 subclones for a two week screening by NCI. Phase IIIb: Rabbit Monoclonal Antibody Service - Expand up to three (3) final hybridoma subclones from each parental clone as frozen cells. The period of performance shall be for eight (8) months. The rabbit immune system generates antibody diversity and optimizes affinity by mechanisms that are more efficient than those of mice and other rodents. This increases the possibility of obtaining a functional antibody that will work in a variety of applications. Epitomics RabMab technology is the only currently available hybridoma based technology for making rabbit monoclonals and covered under the following U.S. Patents, No. 5,675,063 and 7,429,487. The patents cover not only the rabbit fusion partner cell line but also the method for generating rabbit fusion cell lines (rabbit hybridoma). This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response 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 11 AM EST, on December 9, 2013. All responses and questions must be in writing and faxed to 240-276-5399 or emailed to Reyes Rodriguez, Contracting Specialist via electronic mail at reyes.rodriguez@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 (CCR) and the Online Representations and Certifications Applications (ORCA) through sam.gov. Reference: N02RC45001-57 on all correspondence. Questions/Responses: 1) What phase is the project currently at? It seems as though the parent hybridomas have been constructed and NCI is looking only at the construction of the Hybridoma subclones. Response: NCI is at square one of this project. No animals have been injected. NCI has no hybridomas. 2) We are not a PHS Assured company because we do not handle live animals in our lab. Do we need to become assured or will the subcontracting animal facility's assurance be enough? Response: NCI requires rabbits to be injected and maintained over several weeks before their spleens are harvested. Any company submitting a proposal or quote will need PHS assurance. 3) Is the government and NIH lab ready to work with a new disruptive technology that will deliver a better end product, that is cheaper and delivered faster? Response: NCI has already tried phage display technology with no success. A company with a license to use the cells compatible with rabbit spleen cells is required.