KEY DATES:

Capability Statement Due Date: April 6, 2018 by 5:00PM EST

This Small Business Sources Sought Notice (SBSS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI).

The purpose of this Sources Sought Notice is to identify qualified small business concerns including 8(a), HUBZone or Service-Disabled Veteran-owned business concerns that are interested in and capable of performing the work described herein. The NCI does not intend to award a contract based on responses received nor otherwise pay for the preparation of any information submitted. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned North American Industry Classification System (NAICS) code 621511 with a size standard of $32.5 million is being considered.

NCI may issue a request for quotation (RFQ) as a result of this Sources Sought Notice. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NCI shall arise as a result of a response to this Sources Sought Notice or the NCI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement.

The purpose of the requirement is to manufacture GMP Master Cell bank and Gammaretroviral Vector encoding a T cell receptor targeting the KK-LC-1 antigen and conduct biosafety testing on it. The manufactured Retroviral Vector will be used for ETIB/NCI Clinical trials.

The Contractor shall produce a pilot-scale research grade vector and confirm its suitability. As a result, a Master Cell Bank (MCB) will be generated and approved for GMP use. Upon approval of the MCB, an aliquot shall be used to expand cells to sufficient numbers to produce 10L of gammaretroviral supernatant. The product shall be harvested, filtered, frozen and maintained at < -70o C in aliquots (50 grams/unit). Aliquots of the produced supernatant may be supplied to ETIB/NCI for research and development and evaluation purposes.

The Contractor shall be responsible for conducting assay analysis to certify the supernatant based on current FDA guidelines. Certification of the supernatant shall include the tests listed below subject to review of current FDA requirements:

• Sterility, Aerobic and anaerobic culture for bacterial and fungal contamination. Fully meets or exceeds 21 CFR 610.12 Sterility guidelines
• Mycoplasma, including broth, agar, and cell culture and meets the recommended procedure for mycoplasma testing according to the Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals, Attachment #2 (1993).
• Detection and Quantitation of residual plasmid DNA Quantitative Polymerase Chain reaction - QPCR)
• Detection of Human DNA.
• In-Vitro Adventitious Virus Assay.
• Safety testing for replication-competent retrovirus (GAL-V RCR).
• Endotoxin.
• Vector insert stability.
• Lyme disease testing (Transfer of E1A).
• Testing for Simian virus (Transfer of SV40).

The Contractor shall provide 3-year Vector stability testing following the production of the GMP Master Cell bank.

NON-CONFORMING VECTOR

In the case that the manufactured gammaretroviral vector is found non-conforming within 30 days of delivery of a certificate of analysis, the Contractor will investigate the alleged non-conformity upon request of NCI / ETIB. If the non-conforming product is a result of the Contractor's negligence, the Contractor will opt to either replace the gammaretroviral vector within 240 days from the date that the vector is determined to be non-conforming or refund the purchase price of the non-conforming vector. In the case of dispute regarding the non-conformity of the vector, samples of the vector will be submitted to a mutually agreed third party lab or consultant for evaluation.

TYPE OF ORDER

This is a firm fixed price task order.

NON-SEVERABLE SERVICES

The services specified in each contract line item (CLIN) have been determined to be non-severable services - a specific undertaking or entire job with a defined end product of value to the Government.

PERIOD OF PERFORMANCE

The period of performance shall be in accordance with the table below:

Phase Duration

Manufacture of the Master Cell Bank and Gammaretroviral Vector- 8 months from the culture initiation
Vector Stability Testing - Year 1- 1 year from the manufacture completion
Vector Stability Testing - Year 2- 1 year from the end of year 1
Vector Stability Testing - Year 3- 1 year from the end of year 2

PLACE OF PERFORMANCE

The service shall be conducted at the Contractor's facility.

REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

The Contractor shall provide a written monthly progress report to the NCI technical point of contact on the status of individual projects or assays. Upon completion of the manufacturing process and the safety assays, the contractor shall issue and provide a Certificate of Analysis (CoA) and the Gammaretroviral Vector will be released for distribution. As directed by ETIB/NCI and within 8 months of release for distribution, the vector shall be distributed to ETIB/NCI. The deliverables will be 50-100mL sized cassettes (size to be determined between ETIB/NCI and contractor) of frozen gammaretroviral vector along with a detailed Certificate of Analysis.

MILESTONES

Milestones are determined per the table below:

Milestone Number Description
1 Manufacture of Master Cell Bank
2 Manufacture of Gammaretroviral Vector
3 Release of Final Product / Issuance of Certificate of Analysis

DELIVERY POINT:

All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the unique specifications described herein. All questions must be in writing and should be emailed to Ricky Watson, Contract Specialist at [email protected]. A determination by the Government not to compete this 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. In order to receive an award, contractors must have valid registration and certification in the System for Awards Management (SAM) at www.sam.gov. No collect calls will be accepted. Please reference number SBSS- N02CO82536-95
on all correspondence.

Disclaimer and Important Notes:
 
This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, an RFQ may be published. However, responses to this notice will not be considered adequate responses to a solicitation(s).

POINT OF CONTACT:

Inquiries concerning this Notice may be direct to:
Ricky Watson
9609 Medical Center Dr.
Bethesda, MD 20892-9705
[email protected]