Acquisition of Custom Gene Synthesis and Custom Peptide Synthesis Services
Added: Jul 29, 2017 10:18 am Contracting Office Address:Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E144, Bethesda, MD 20892, UNITED STATES. Description:The National Cancer Institute (NCI), Center for Cancer Research (CCR), Surgery Branch (SB), plans to procure, on a sole source basis, custom gene synthesis and custom peptide synthesis services from GenScript USA, Inc,; 860 Centennial Ave.; Piscataway, NJ 08854 USA.The response close date of this notice for this requirement is in accordance with FAR 5.203(a)(1). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(2), and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 325413 and the business size standard is 1,250 employees.Only one (1) award 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 thirty-six (36) months from date of award.It has been determined there are no opportunities to acquire green products or services for this procurement.The Surgery Branch 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. The Surgery Branch was responsible for the development of interleukin-2 (IL-2), the first effective immunotherapy in humans, the development of cell transfer immunotherapies for melanoma and other solid cancers, the first insertion of foreign genes into humans and the first development of effective human cancer immunotherapies based on the genetic engineering of autologous lymphocytes with genes encoding anti-tumor T cell receptors or chimeric antigen receptors.Examples of current laboratory research involve the identification of the optimal properties of lymphocytes capable of mediating anti-tumor effects in experimental models and in the human and the development of immunotherapies based on the identification of unique exomic mutations expressed by cancers that can be targeted by cell transfer therapy. Extensive programs are in place for the genetic modification of lymphocytes to target cancer-testes antigens.The National Cancer Institute (NCI), Surgery Branch (SB) is developing immune-based therapies to treat patients with metastatic cancer. One of the branch's current major therapeutic strategies is to use tumor mutation-reactive T cells to treat patients with cancer. This is based on data from the SB 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 NCI 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. The SB is thus attempting to treat more patients with mutation-reactive T cells. In order to do this, the SB first must identify mutation-reactive T cells from patients. The reagents that the branch requires to identify mutation-reactive T cells are custom genes and custom peptides that encode for tumor mutations. Since the SB is using these reagents in "real time" to develop therapies to treat patients with late stage cancer, the branch requires that these reagents be synthesized quickly, be error-free and that the product sequences are of high quality.One major focus of the Branch is to develop T-cell therapies that target mutations expressed by the patients' cancer. This process begins with the resection of tumor from the patient. The T cells within the tumor are then grown in the lab. The SB performs whole-exome and whole-transcriptome sequencing on the tumors to identify somatic mutations. Once the branch has a list of mutations, the SB requires the synthesis of mini-gene constructs that encode the mutations, and also short and long peptides that encode the mutations. This is where the branch requires the proposed source to provide high quality genes and peptides for NCI's experiments in a timely manner. Once the branch obtains these constructs encoding the mutations, the SB interrogates whether the T cells grown out from the patients' tumor recognize any of these mutations. If there are T cells that recognize any of these mutations, then the branch selects those T cells to treat the patient. The patients being treated at the SB are late-stage patients with no other therapeutic options, thus the NCI requires that all these reagents be synthesized in an expeditious manner as time is of the essence. This process is required for every single patient on the SB protocol (i.e., this is highly personalized medicine/therapy).The Contractor shall provide all labor, material, and equipment to provide the following:TECHNICAL REQUIREMENTS:The Contractor shall provide the following task areas:Task #1: Make crude peptides (9-25 amino acids in length) that encode endogenous protein sequence with tumor mutations embedded. Peptides will be quality controlled via MS analysis to determine amino acid sequence is at least 75-80% purified. Contractor Quality Requirements: All products generated from the contractor will be Mass Spectrometry and DNA sequence verified. The minimum quantity of crude peptides to be ordered for this Task Area will be (180), and the maximum quantity of crude peptides to be ordered will be (36,000) during the entire Period of Performance of the IDIQ contract.Task #2: Make genetic constructs that encode the tumor mutations. Provide the appropriate documentation and files of the sequence analysis. The minimum quantity of constructs, and associated documentation and analysis, to be ordered for this Task Area will be (72), and the maximum quantity of constructs, and associated documentation and analysis, to be ordered will be (5,400) during the entire Period of Performance of the IDIQ contract.For both task areas, the Contractor shall communicate to the NCI Contacting Officer's Representative immediately via email or phone call if any problems. The Contractor shall notify the NCI Contacting Officer's Representative (COR) immediately via e-mail or phone call if any unusual problems develop over the course of the project and/or explanations for repeating analyses, such as failure of analytical and quality control procedures, breakdown of freezers, instrumentation and equipment, and major changes in personnel that would produce delays or that would adversely influence the quality of the laboratory performance. For both task areas, any residual samples will be stored in the laboratory at -80 degrees Centigrade. All biological materials provided by the U.S. Government, all residual specimens, and all data generated shall be the property of the U.S. Government and shall be returned to the U.S. Government repository after the assays are completed and data approved by the NCI COR.REPORTING REQUIREMENT AND DELIVERABLES: The Contractor shall provide the following in coordination with the NCI COR:1. Sequence data of the constructs. The constructs will be DNA sequenced for verification, and electronic files that describe the generated product. The files will contain electropherograms showing the DNA sequence of the constructs. These will show the cloning site as well as the full length insert.2. Lyophilized crude peptides containing the specific amino acid sequence.3. Genetic constructs encoding the mutations cloned into an expression plasmid. 4. Peptides will be made and delivered within 2-4 weeks of order depending on complexity of sequence and length of peptide.5. Genetic constructs will be made and delivered within 3 weeks of order.INSPECTION AND ACCEPTANCE CRITERIAThe reports, containing relevant data items, per above, will be scrutinized prior to acceptance. Acceptance will occur within thirty (30) calendar days of receipt, and prior to the end of the Period of Performance.GOVERNMENT RESPONSIBILITIES:The NCI COR will provide genomic DNA and mRNA from tumor samples from patients enrolled in NCI Surgery Branch clinical trials will have whole-exome and RNASeq libraries made and sequenced on Illumina NextSeq 500 and 550 desktop sequencers.The NCI COR will send Word and Excel documents indicating the DNA constructs to be synthesized.PAYMENT:The number of productions will be indefinite delivery indefinite quantity. Refer to Section C for the minimum quantity and maximum quantity for each Task Area during the Period of Performance of the IDIQ contract. Payment will be made in arrears after receipt and acceptance of requested tasks.CLAUSES:ORDERING AND ORDERING LIMITATIONS: 1. FAR 52.216-18 Ordering (Oct 1995)(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from THIRTY-SIX (36) months from date of award.(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.(c) If mailed, a delivery order or task order is considered "issued" when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule. (End of clause)2. FAR 52.216-19 Order Limitations (Oct. 1995)(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than minimum quantity stated, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.(b) Maximum order. The Contractor is not obligated to honor-(1) Any order for a single item in excess of the maximum quantity stated;(2) Any order for a combination of items in excess of the maximum quantity stated; or(3) A series of orders from the same ordering office within 30 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section. (d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within ten (10) days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.(End of clause)Note: The Contractor shall NOT provide any service over the maximum number of quantity stated for the contract Period of Performance. Doing so will be at their own risk.3. FAR 52.216-22 Indefinite Quantity (Oct. 1995)(a) This is an indefinite-quantity contract for the supplies or services specified and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after Period of Performance.(End of clause)The services are provided by GenScript USA, Inc. The National Cancer Institute (NCI), Surgery Branch (SB), requires custom made gene synthesis and cloning, and custom made peptides. The proposed Vendor can meet all of the Branch's technical requirements in the Statement of Work in a cost effective and timely manner. The proposed Vendor is a pioneering DNA synthesis company and is the largest gene synthesis supplier in the United States. The proposed Vendor developed its Gene-on-Demand® technology platform, which brings together proprietary OptimumGeneTM codon optimization technology and CloneEZ® seamless cloning technology for the synthesis of GC-rich and extremely long genes. This has allowed the proposed Vendor to synthesize and clone challenging genes into any vector. This is relevant to the NCI, as the genes that the SB requires are truly unique and can be highly diverse and potentially complicated. The proposed Vendor has a large gene synthesis capacity (over 7.5 million bp/month) and proprietary technologies enable them to deliver custom de novo genes of any length and any complexity. The proposed Vendor provides high-quality peptide synthesis service with a 95% peptide synthesis success rate, which is well above the industry standard of 75%.The SB's protocol is ongoing. The performance characteristics and quality of the needed services are required for maintaining the integrity of the stated protocol. A change would be disruptive to the ability to analyze SB's cumulative results, which are based on prior services provided by the proposed source. Any deviation imposed on the unique protocol could ruin countless hours of research, distort and destroy the integrity of data, significantly delay the SB's toughput, and ultimately impede the ability to provide vital, contemporaneous treatment to terminal patients. There is no other capable source available to the SB to advance its scientific mission.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 10:30AM EDT, on August 9, 2017. All responses and questions must be in writing and faxed (240) 276-5401 or emailed to Catherine Muir, Contracting Officer via electronic mail at muirca@mail.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, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) tough SAM.gov. Reference: N02RC72524-76 on all correspondence. N02RC72524-76 Department of Health and Human Services National Institutes of Health
7/29/17, 10:18 AM