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The National Cancer Institute (NCI), Center for Cancer Research (CCR), Molecular Imaging Branch (MIB), plans to procure, on a sole source basis, custom recombinant antibody production of anti-mouse Er... The National Cancer Institute (NCI), Center for Cancer Research (CCR), Molecular Imaging Branch (MIB), plans to procure, on a sole source basis, custom recombinant antibody production of anti-mouse ErbB2 (HER2) domain IV 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)(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. The period of performance: 139 business days from date of the award.. It has been determined there are no opportunities to acquire green products or services for this procurement. The mission of the U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Molecular Imaging Branch (MIB) is to advance cancer therapies using molecular imaging. The MIB conducts research in designing, developing and testing new novel targeted imaging agents for the detection and characterization of cancer. These imaging agents include tissue-specific MRI, Positron Emission Tomography (PET), radionuclide, and optical probes. The MIB is focused on the clinical translation of targeted imaging agents for cancer imaging. The goal of the Molecular Imaging Branch (MIB) is to develop targeted imaging methods that accelerate the development of cancer therapies. The MIB is focused on the development and translation of in vivo molecular imaging agents for early detection, monitoring and therapy. Given the high risks and high costs of conducting research in this field, the MIB is well positioned to address the challenges that the field of molecular imaging faces. This requirement is specifically for the Laboratory of Theranostics. This lab has developed activatable optical contrast agents. Additionally, this lab has identified antibody-photosensitizer conjugates (APCs) that produce highly targeted necrotic cell death. This has been termed "photoimmunotherapy" and has entered clinical trials. This lab is also developing a variety of radionuclide-targeted imaging agents for clinical translation. Within the pre-clinical section of the MIB is the Lab of Thernostics, which is focusing on photoimmunotherapy (PIT). PIT is a cancer treatment developed in MIB that kills target cells specifically. PIT uses antibody-photoabsorber-conjugate (APC), which binds to the cell surface antigen expressed in the cancer cells, and upon near-infrared light irradiation, APC-bound cancer cells are killed. HER2 is often highly expressed in various cancers, including breast and colon cancers, which makes it ideal for a target of PIT. Currently, HER2-targeted antibody drugs are in clinical use, and several antibody drugs are available. These antibody drugs have the potential to be used as PIT agents. Before proceeding to clinical evaluation, pre-clinical studies using mice are needed. Ideally, the antibody for the pre-clinical research mimics the function of human HER2 antibody in clinical use. The required services are needed since there are no commercially off the shelf available mouse HER2 that mimics HER2 binding site, domain IV, and neither the MIB nor NIH has the capabilities of providing the anti-mouse HER2 antibody. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government. The Contractor shall provide all labor, material, and equipment necessary to perform the custom antibody production of against mouse ErbB2 domain IV. All work for protein production will be performed off-site. The recombinant antibody production service shall include; Immunization of 4 rabbits with the antigen protein (mouse ErbB2 domain IV). MIB will ship the Contractor the antigen protein. Collecting B cell clones and performing positive screening for mouse HER2 binding, negative screening for Fc binding, also test human HER2 binding. MIB will provide mouse and human HER2 protein, and the contractor will provide Fc-tagged protein for negative screening. Collecting supernatants of at least 20 clones of candidate antibodies. The positive supernatants will be sent to MIB for in-house screening to choose 5 top candidates. protein sequencing for at least five candidate clones production/purification of recombinant antibody TECHNICAL REQUIREMENTS: The Contractor shall provide the following task areas: Custom Rabbit Monoclonal Antibodies-mouse ErbB2 Domain IV Service Type: Whole package service Name of the antigen: mouse ErbB2 Domain IV Host animals: Rabbits Material preparation and Validation Antigen name: mouse ErbB2 Domain IV Antigen Type: Protein Antigen Source: From GenScript Conjugation: No ImmunoPlus: No Validation Method: SDS-PAGE Material preparation and Validation Antigen name: human ErbB2 Domain IV Antigen Type: Protein Antigen Source: From GenScript Conjugation: No ImmunoPlus: No Validation Method: SDS-PAGE Animal Immunization Animal species: Rabbit Animal strain: New Zealand Rabbit Animal numbers: 4 Immunization strategy: Rabbit Conventional-3 immunizations Animal facility accreditation: AAALAC & OLAW QC: Assay format: Indirect ELISA Material name: mouse ErbB2 Domain IV Expected signals: Positive Assay format: Indirect ELISA Material name: human ErbB2 Domain IV Expected signals: Positive Assay format: Indirect ELISA Material name: Fc tagged irrelevant protein Expected signals: Negative Deliverable: Negative control: IgG control (SC2014) Post-immune: 0.1mg antigen affinity purified antibody Comments: One additional boost for four rabbits Antibody Purification Purification Method: Antigen affinity purification Purification type: Separated purification Purification requirement: Antigen purification Purification Sample Type: supernatants Purification Sample Volume: 14ml/rabbit*4 rabbits QC: Assay format: Indirect ELISA Material name: mouse ErbB2 Domain IV Expected signals: Positive Assay format: Indirect ELISA Material name: human ErbB2 Domain IV Expected signals: Positive Assay format: Indirect ELISA Material name: Fc tagged irrelevant protein Expected signals: Negative Deliverable: Antibody Form: Liquid Preservative: 0.02% Proclin 300 Antibody Concentration: >0.3mg/ml Sterile Filtration: No Low EU: No Cell Fusion Operation aspects: PBMC collection Fusion number: 1 Plate number for fusion: up to 50 QC: Assay format: Indirect ELISA Material name: mouse ErbB2 Domain IV Expected signals: Positive Assay format: Indirect ELISA Material name: human ErbB2 Domain IV Expected signals: Positive Assay format: Indirect ELISA Material name: Fc tagged irrelevant protein Expected signals: Negative Deliverable: Up to 20 parental supernatants Antibody SequencingClone ID: Up to 5 Clone Number: 1 Sequencing requirement: Standard variable domain and leader sequence sequencing Deliverable: Sequencing report,Alignment data,Sequence raw data Antibody Production Hybridoma Source: From GenScript Clone ID: up to 5 Antibody production method: By recombinant antibody production Expected antibody yield: 0.1-0.2mg Need purification: Yes QC: Assay format: Indirect ELISA Material name: mouse ErbB2 Domain IV Expected signals: Positive Assay format: Indirect ELISA Material name: human ErbB2 Domain IV Expected signals: Positive Assay format: Indirect ELISA Material name: Fc tagged irrelevant protein Expected signals: Negative Antibody Purification Purification Method: Protein A purification Purification Sample Type: supernatants QC: Assay format: Indirect ELISA Material name: mouse ErbB2 Domain IV Expected signals: Positive Assay format: Indirect ELISA Material name: human ErbB2 Domain IV Expected signals: Positive Assay format: Indirect ELISA Material name: Fc tagged irrelevant protein Expected signals: Negative Deliverable: Antibody Form: Liquid Preservative: 0.02% Proclin 300 Antibody Concentration: >0.3mg/ml Sterile Filtration: No Low EU: No TYPE OF ORDER This is a firm fixed price purchase order. PERIOD OF PERFORMANCE The period of performance shall be for 139 days from date of award. PLACE OF PERFORMANCE All work will be performed at the Contractor’s facility. REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE The Contractor will send an update every month about their progress via email or teleconference which will allow the MIB to stay up to date and discuss the next steps. If there is an urgent need for the Contractor to contact the MIB, the Contractor will contact via email or phone call. Complete deliverables schedule listed below. DELIVERABLE DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS #4 (see Tasks for correlation) Negative control: IgG control (SC2014) Post-immune: 0.1mg antigen affinity purified antibody #5 Antibody Form: Liquid Preservative: 0.02% Proclin 300 Antibody Concentration: >0.3mg/ml Sterile Filtration: No Low EU: No #7 Sequencing report,Alignment data,Sequence raw data #9 Antibody Form: Liquid Preservative: 0.02% Proclin 300 Antibody Concentration: >0.3mg/ml Sterile Filtration: No Low EU: No PAYMENT Payment shall be made with a purchase order. Payment authorization requires submission and approval of invoices to the NCI Technical Point of Contact that will be on the Purchase Order, and to the NIH Office of Financial Management (OFM), in accordance with the payment provisions listed below: The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: Prompt Payment (Jan 2017) FAR 52.232-25. Highlights of this clause and NIH implementation requirements follow: INVOICE REQUIREMENTS An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below.) Untimely notification will be taken into account in the computation of any interest penalty owed the Contractor. Vendor/Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact). Remit-to address (Name and complete mailing address to send payment). Remittance name must match exactly with name on original order/contract. If the Remittance name differs from the Legal Business Name, then both names must appear on the invoice. Invoice date. Unique invoice #s for all invoices per vendor regardless of site. NBS document number formats must be included for awards created in the NBS: Contract Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number. Unique Entity Identifier (UEI) which is in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number. Federal Taxpayer Identification Number (TIN). In those rare cases where a Contractor does not have a UEI number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the contractor’s name on the face page of the award document. Identify that payment is to be made using a three-way match. Description of supplies/services that match the description on the award, by line billed.* Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.* NOTE: If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid. Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt. The Contractor shall submit invoices to the Department of Treasury’s Invoice Processing Platform (IPP) at https://www.ipp.gov with a copy to the approving official, as directed below. The Contractor shall submit a copy of the electronic invoice to the following Approving Official (Contracting Officer) and Contracting Officer Representative: Approving Official: Contracting Officer Name- Email Address- Contracting Officer Representative Name- Email Address- Invoice Payment Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events: The 30th day after the designated billing office has received a proper invoice. The 30th day after Government acceptance of supplies delivered or services performed. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended. Interest PenaltiesAn interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable. A proper invoice was received by the designated billing office. A receiving report or other Government documentation authorizing payment was processed and there was no disagreement over quantity, quality, or Contractor compliance with a term or condition. In the case of a final invoice for any balance of funds due the Contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor. Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR 52.232-40 (Mar 2023). (a) In accordance with 31 U.S.C. 3903 https://www.govinfo.gov/link/uscode/31/3903 and 10 U.S.C. 3801 https://www.govinfo.gov/link/uscode/10/3801 , within 15 days after receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor. The Contractor agrees to make such payments to its small business subcontractors without any further consideration from or fees charged to the subcontractor. (b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act. (c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services. (End of clause). HHSAR 352.232-71 Electronic Submission of Payment Requests (February 2, 2022). Definitions. As used in this clause— Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), ‘‘Content of Invoices’’ and the applicable Payment clause included in this contract. (b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site. (c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures. (d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer’s written authorization with each payment request. (End of clause). The services are provided by GenScript USA, Inc. The National Cancer Institute (NCI), Molecular Imaging Branch (MIB), requires custom recombinant antibody production of anti-mouse ErbB2 (HER2) domain IV services. 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 MIB’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 MIB’s cumulative results, which are based on prior services provided by the proposed source. Deviation imposed on the unique protocol could ruin hours of research, distort and destroy the integrity of data, significantly delay the MIB’s throughput, and ultimately impede the ability to provide contemporaneous treatment to patients. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirements, it may submit a capability statement 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 conclusively determine if the party can perform all of the technical requirements identified above. Responses must be received by 10:00 AM ET, on August 28, 2023. All responses and questions must be in writing 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) through SAM.gov. Reference: 75N91023Q00164 on all correspondence.