Good Manufacturing Practice (GMP) Grade Lipopolysaccharide (LPS) Vials for Manufacturing Cancer Vaccines in Clinical Trials

1.0 DESCRIPTION

The Center for Cancer Research (CCR) plans to procure services, on a sole source basis, from List Labs, 540 Division Street, Campbell, CA 95008-6906.

The response close date of the notice for this requirement is in accordance with FAR 5.203(b). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1(b)(1)(i); and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541715 and the small business size standard is 1,000 employees.

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

2.0 BACKGROUND

LPS is used to manufacture cancer vaccines using patients' immune cells at NIH. Cancer vaccines are regulated by the FDA as investigational new drugs (IND) and clinical trials are conducted under the sponsorship of NCI/CCR. LPS is one of critical ancillary agents growing patients' immune cells at NIH Center for Cellular Engineering listed in the file of FDA IND and cannot be arbitrarily replaced to a different agent from a different manufacturer. The reason for a new order is due to anticipated exhaustion of the current inventory that is set to expire on Jun 1, 2024. Renewal of the expiration is not allowed by the regulatory authorities of this product. This must be provided to NIH Center for Cellular Engineering to continue clinical trials.

3.0 TYPE OF ORDER

This is a Firm Fixed-Price Purchase Order.

4.0 SPECIAL ORDER REQUIREMENTS

The Contractor shall provide the following item(s) or equivalent:

Item Description Manufacturer Part # Quantity
1 LPS 1 microgram/vial 9433A 52

4.1 PRODUCT FEATURES/SALIENT CHARACTERISTICS

The following product features/characteristics are required for this requirement:

52 vials of GMP certified LPS vials of lyophilized 1 microgram/vial.
Vendor is the manufacturer of the IND listed LPS vials.
Certificate of analysis

4.2 DELIVERY / INSTALLATION

Items (vials and release document) shall be delivered within 60 days of purchase order award upon the request of shipment by the NCI Vaccine Branch. The shipping has to be prearranged by contacting (TPOC TBD) by email to ensure the readiness of the receiving party. Each shipment will go directly to:

(TBD)
NIH Clinical Center
10 Center Drive, Room 3C709
Bethesda, MD 20892-1184

4.3 TRAINING

No training is required for this acquisition.

4.4 WARRANTY

The Contractor shall warrant all supplies furnished under this award against any defects in
design, material, or manufacture for a period of at least twelve (12) months from the date of
installation. The Contractor shall also warrant and imply that all items delivered as a result of
this order are merchantable and fit for use for the particular purpose described in the order in
accordance with FAR 52.212-4(o).

If a defect results in lost or decreased performance of supplies or services furnished under this
order, the Contractor shall cover all parts, materials, labor, and/or travel expenses required to
repair or replace the supplies at no cost to the Government.
Supplies which are repaired or replaced shall be warranted for the remainder of the initial
warranty period or for 90-days whichever is greater.

5.0 UNIQUE QUALIFICATIONS OF THE CONTRACTOR

Using this particular vendor's product is critical because once the GMP reagent is listed in an IND, that triggers a master file with the manufacturer that the sponsor of the clinical trial will send to the FDA. Arbitrary changes in the reagent including the vendor, size, dose, mode of administration, or location of storage/usage is not allowed and must be reported. To change the vendor, more specifically, changing the vendor will set the clinical study that is open as of 5/7/2024 to go back to engineering runs (test runs to generate the data to submit to the FDA).

List Laboratory-manufactured lipopolysaccharide (LPS) that is used in FDA filed IND as a part of ancillary agents for dendritic cell vaccine manufacturing is from E. coli 0113 strain and must be GMP grade to be used in clinical trials. Once FDA reviews the submission, then the sponsor office (NCI) will approve the study to be reviewed by the NIH IRB and get ready with the NIH Clinical Center resources. The entire process is highly coordinated and regulated. The information and the quality control of involved material are extremely restricted. To aid the review process, previous lead time from FDA submission to study opening took 8 month with multiple personnel involved; so, if there is a change in the reagent, that process has to be revisited. List Laboratory is the only available source of such a quality. Without securing the supply of a new lot of LPS, clinical trials will cease. Thus, it is essential to proceed with the purchase of LPS vials in order to conduct clinical trials at the Vaccine Branch.

6.0 SUBMISSION INSTRUCTIONS

This notice is not a request for competitive quotations. However, if any interested party believes it can meet the above requirements, 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. All responses and questions must be sent via email to the Contract Specialist, Dana Summons, at dana.summons@nih.gov by no later than 3:00 PM EST on June 5, 2024, (6/5/24). 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. Reference: 75N91024Q00112 on all correspondence.