The U.S Department of Health and Human Services, National Institutes of Health, National Cancer Institute (NCI), Center for Cancer Research (CCR), Pediatric Oncology Branch plans to procure, on a sole source basis, services for Vector Analysis of Replication-Competent Retrovirus (RCR) in ongoing clinical trials, to Indiana University Vector Production Facility (IU VPF), of Indiana University School of Medicine, 980 West Walnut Street, Indianapolis, IN 46202.

This acquisition will be processed in accordance with simplified acquisitions procedures as stated in FAR Part 13.106-1(b)(1) and is exempt for the requirements of FAR Part 6. The North American Industry Classification System code is 541380, and the business size standard is $15.0 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 anticipated period of performance shall be September 15, 2015 through January 31, 2016. It has been determined there are no opportunities to acquire green products or services for this procurement.

BACKGROUND
The NCI/CCR/Pediatric Oncology Branch is committed to bringing new cutting edge therapies to children with leukemia. The Pediatric Oncology Branch has been instrumental in treating children with T lymphocytes (white blood cells from the patient) that have been modified with retroviral gene vectors. The Pediatric Oncology Branch currently has an open clinical trial for T cells modified with a chimeric antigen receptor (CAR) specific for the leukemia tumor antigen CD19.
 
In the trial, the Pediatric Oncology Branch is conducting a trial of immunotherapy for the patients with leukemia and solid tumors, in which lentiviral vectors and gamma retro viruses are used as important tools to achieve long-term expression and stable integration of a gene of interest in a target cell, such as CD19 CAR in T cells, etc. A principle concern regarding the use of either lentiviral or gamma retroviral vectors is the potential to generate a retrovirus (RCR). The known pathogenicity of leukemia retroviruses (RCRs) associated with these vectors requires strict monitoring of gene therapy products. At present, the Food and Drug Administration (FDA) has set forth to perform RCR detection primarily by a combination of biological (extended S+/L- assay) and molecular methods (PCR) for retroviral vectors, and p24gag ELISA/gag PCR for lentiviral vectors.

The Contractor shall provide a laboratory environment which conforms to good manufactory practice requirements mandated by the FDA, in order to perform Vector Analysis of Replication Competent Retrovirus (RCR) for 13 samples. Lab equipment shall be suitably sized and located to facilitate maintenance, cleaning and proper operation.
 
All testing facilities shall have written standard operating procedures in place to define nonclinical study methods in laboratory settings. The quality assurance is in place to monitor each study by ensuring that the equipment, facilities, staff, test methods and documentation conform to written regulations.

The tests shall be conducted on CCR's gene products using clinical Good Manufacture Protocol (cGMP) standards and the results shall be provided to the NCI Contracting Officer's Representative (COR) to be included in the submission packet to the FDA for the Investigative New Drug (IND) for this product.

TASKS
The Contractor shall:

1. Perform Vector Analysis of Replication Competent Retrovirus (RCR) for 13 samples.

2. Perform a quality assurance review of manufacturing records and test results for 
compliance with FDA standards:

    • Facilities must be designed to keep separate all testing areas, so as to ensure that
       no lab results can be affected by accidental mishaps.
    • All equipment, such as computers and manufacturing machines, must be routinely
       inspected, calibrated and checked according to written regulations designed to
       ensure proper performance.
    • Written records of all inspections, calibrations and checks must be kept for
       management review (in the contractor for further references).

IU VPF is the only facility that can analyze a cell line that can be used by the CCR / Pediatric Oncology Branch for clinical studies, using a technology that insures cGMP-grade manufacture and FDA compliance of the producer line, which is required for future clinical studies. Only IU VPF has a track record of consistently producing such lines in a clinic-ready manner.

This is a highly custom assay, created in part by intellectual property held by HHS/NIH, created by the requesting laboratory. In researching this product, the Pediatric Oncology Branch found only one other lab capable of custom retroviral vector producer line assay, but the assay is not equivalent as it does not begin with a pre-FDA approved cell line, and no economy of scale can be granted at that facility. It is only at the IU VPF where the CCR / Pediatric Oncology Branch's request can be met.

This is not a solicitation for competitive quotations. However, if any interested party especially small business, believes they can meet the above requirement, they may submit a capability statement, proposal, or quotation which will be considered by the agency. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the needs of the requirement described herein. Reponses must be submitted via email only to Contract Specialist, Megan Kisamore, at [email protected], no later than 11:00 am EST, Tuesday, September 1, 2015. All questions must be emailed to [email protected]. Capability statements will not be accepted after the due date. A determination by the Government not to compete this proposed contract 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. In order to receive an award, contractors must have valid registration and certification in the System for Award Management (SAM) at www.sam.gov. No collect calls will be accepted. Please reference solicitation number N02RC52690-76 on all correspondence.

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