N02CO62712-78

General Information
Short Title: Production of 40 liters of high titer clinical grade lentiviral vector stock.
Document Type: Presolicitation Notice
Solicitation Number: N02CO62712-78
Posted Date: 9/11/2016
Response Date: 9/14/2016 8:00 AM ET
Classification Code: 6505
NAICS Code: 325414

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E136, Rockville, MD 20850, UNITED STATES

Description

National Cancer Institute (NCI), Center for Cancer Research (CCR), Lymphoid Malignancies Branch (LMB), plans to procure on a sole source basis, production of 40 liters of high titer clinical grade lentiviral vector stock, from the Indiana University IUPUI, 980 W. Walnut Street, Indianapolis, IN 46202.

This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.501. The North American Industry Classification System code is 325414 and the business size standard is 1250 employees.

The period of performance is twelve (12) months from date of award.

It has been determined there are no opportunities to acquire green products or services for this procurement.

The purpose of the project is to design a chimeric antigen receptor that can be expressed in autologous T cells and when infused back into the patient these chimeric antigen expressing ex vivo modified T cells will seek out cancer cells and destroy them. Specifically, The LMB has designed a chimeric antigen expression unit by incorporating a gene moiety that codes for an antibody variable fragment that can engage CCR4 molecules that is over expressed in cutaneous T cell lymphoma and adult T cell lymphoma in a lenti viral vector. The LMB will produce the lentiviral stock under FDA mandated cGMP conditions at the Contractor's production facility through this contract. Once the vector stock is available, the LMB can use this vector to ex vivo engineer patient's T cells to achieve the LMB's goal of developing a therapeutic strategy to treat these cancers.

Contractor Requirements:

The Contractor shall:
Technical Considerations

• Produce 40 liters of cGMP lenti-vector (consists of 1x40 liters)
• Check the produced vector for sterility
• Perform in vitro viral assays
• Perform p24 assays to quantitate the vector titer
• Perform assays to exclude the presence of replication competent live lenti virus
• Perform tests for endotoxin levels in the preparation
• Perform qPCR for the presence of adenoviral E1A contamination from the host cell substrate
• Perform qPCR for SV40 for the presence of adventitious SV40 virus
• Perform vector insert stability assessment
• Check for the presence of Benzonase
• Check for the presence of contaminating human DNA
• Perform tests to exclude mycoplasma contamination

Requirements/Deliverables:

The Contractor shall

A. Tasks
Production of 40 liters of lenti virus stock under cGMP

B. Reports
Purity data and sequence data shall be submitted to the COR.

C. Deliverables
i. The vendor will generate a small scale preparation of the lenti virus vector for testing and ship to the COR within one month of receiving the vector plasmid.

ii. 400 vials or bags each containing 100mls of vector. The Contractor shall deliver the lentiviral stock to a cGMP compliant biorepository at Fisher Bioservices Inc.,14665 Rothgeb Drive, Rockville, MD 20850-5312, using an appropriate mode of transport for cGMP material.

Quality Assurance:

The product shall be synthesized, sequence verified, and purity checked by the Contractor.

Inspection and Acceptance Criteria:

The NCI shall review and accept the deliverables within two weeks after delivery. If no comments or request for revisions are provided, then the deliverables shall be considered acceptable.

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 8 AM ET, on September 14, 2016. All responses and questions must be via email to Francisco Mendoza, Contracting Specialist at francisco.mendoza@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. In order to receive an award, contractors must be registered and have valid certification through SAM.GOV and have Representations and Certifications filled out. Reference: N02CO62712-78 on all correspondence.

General Information
Short Title: Production of 20 liters of high titer clinical grade lentiviral vector stock.
Document Type: Presolicitation Notice
Solicitation Number: N02CO62712-78
Posted Date: 9/11/2016
Response Date: 9/14/2016 8:00 AM ET
Classification Code: 6505
NAICS Code: 325414

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E136, Rockville, MD 20850, UNITED STATES

Description

National Cancer Institute (NCI), Center for Cancer Research (CCR), Lymphoid Malignancies Branch (LMB), plans to procure on a sole source basis, production of 20 liters of high titer clinical grade lentiviral vector stock, from the Indiana University IUPUI, 980 W. Walnut Street, Indianapolis, IN 46202.

This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.501. The North American Industry Classification System code is 325414 and the business size standard is 1250 employees.

The period of performance is six (6) months from date of award.

It has been determined there are no opportunities to acquire green products or services for this procurement.

The purpose of the project is to design a chimeric antigen receptor that can be expressed in autologous T cells and when infused back into the patient these chimeric antigen expressing ex vivo modified T cells will seek out cancer cells and destroy them. Specifically, The LMB has designed a chimeric antigen expression unit by incorporating a gene moiety that codes for an antibody variable fragment that can engage CCR4 molecules that is over expressed in cutaneous T cell lymphoma and adult T cell lymphoma in a lenti viral vector. The LMB will produce the lentiviral stock under FDA mandated cGMP conditions at the Contractor's production facility through this contract. Once the vector stock is available, the LMB can use this vector to ex vivo engineer patient's T cells to achieve the LMB's goal of developing a therapeutic strategy to treat these cancers.

Contractor Requirements:

The Contractor shall:
Technical Considerations

• Produce 20 liters of cGMP lenti-vector (consists of 1x20 liters)
• Check the produce vector for sterility
• Perform in vitro viral assays
• Perform p24 assays to quantitate the vector titer
• Perform assays to exclude the presence of replication competent live lenti virus
• Perform tests for endotoxin levels in the preparation
• Perform qPCR for the presence of adenoviral E1A contamination from the host cell substrate
• Perform qPCR for SV40 for the presence of adventitious SV40 virus
• Perform vector insert stability assessment
• Check for the presence of Benzonase
• Check for the presence of contaminating human DNA
• Perform tests to exclude mycoplasma contamination

Requirements/Deliverables:

The Contractor shall

Tasks
Production of 20 liters of lenti virus stock under cGMP

Reports
Purity data and sequence data shall be submitted to the COR.

Deliverables
400 tubes each containing 50mls of vector. The Contractor shall deliver the lentiviral stock to the NCI COR, using an appropriate mode of transport for cGMP material.

Quality Assurance:

The product shall be synthesized, sequence verified, and purity checked by the Contractor.

Inspection and Acceptance Criteria:

The NCI shall review and accept the deliverables within two weeks after delivery. If no comments or request for revisions are provided, then the deliverables shall be considered acceptable.

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 8 AM ET, on September 14, 2016. All responses and questions must be via email to Francisco Mendoza, Contracting Specialist at francisco.mendoza@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. In order to receive an award, contractors must be registered and have valid certification through SAM.GOV and have Representations and Certifications filled out. Reference: N02CO62712-78 on all correspondence.