GMP grade lipopolysaccharides (LPS) vials for manufacturing cancer vaccines in clinical trials

General Information Short Title: GMP grade lipopolysaccharides (LPS) vials for manufacturing cancer vaccines in clinical trials Document Type: Notice of Intent Solicitation Number: 75N91022Q00064 Posted Date: 4/22/2022 Response Date: 4/29/2022 Classification Code: B599 - Special Studies/ Analysis NAICS Code: 541380 - Testing Laboratories Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E232 Bethesda, MD 20892, UNITED STATES Description The U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Vaccine Branch intends to procure GMP grade lipopolysaccharides (LPS) vials on a sole source basis from List Labs. This procurement is being conducted using commercial item procedures pursuant to FAR Part 12 and FAR Part 13, specifically FAR Subpart13.106-1(b)(1)(i) allowing the Contracting Officer (CO) to solicit from one source. Only one award will be made as a result of this solicitation. This will be awarded as a Non-Severable firm fixed price type contract. It has been determined there are no opportunities to acquire green products or services for this procurement. BACKGROUND Lipopolysaccharides (LPS) is used to manufacture cancer vaccines using patients immune cells at National Institutes of Health (NIH). Cancer vaccines are regulated by the FDA as investigational new drugs (IND) and clinical trials are conducted under the sponsorship of National Cancer Institute (NCI)/ Center for Cancer Research (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 cannot be arbitrarily replaced by a different agent from a new vendor. The reason for a new order is due to anticipated exhaustion of the current inventory. The difference is that the previous lot was an NIH custom order for a GMP lot while the current order is certified as GMP vials by the vendor. NIH was responsible for quality control and retesting on for the previous order. However, on the new order quality control and expiration is set by the vendor thereby eliminating the need for retest and documentation by NIH. LPS is critical in shaping the dendritic cells in the right quality and it is essential to keep the reagent available for vaccine manufacturing. NCI Vaccine Branch will secure the item in NIH Center for Cellular Engineering designated GMP storage under the regulation of CCR/NCI. TYPE OF ORDER This shall be issued as a Non-Severable Firm Fixed-Price Purchase Order. SPECIAL ORDER REQUIREMENTS PRODUCT FEATURES/SALIENT CHARACTERISTICS The following product features/characteristics are required for this requirement: 160 vials of GMP certified LPS (from E. coli O113) vials of lyophilized 1 microgram/vial . GMP grade material is required and the vendor shall be capable of providing off-the-shelf GMP grade LPS vials. The amount contained in the vial must be consistent with the vaccine manufacturing method in order to optimization usage. The LPS strain must be from E.coli O113:H10:K, because this is the standard used as reference calibrants for bacterial endotoxin testing. The LPS must be compliant with FDA Good Manufacturing Practices (GMP) guidelines found in 21 CFR 211. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, 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 determine if the party can perform the requirement. Responses must be received in the contracting office by 12:00 PM EST, on April 29, 2022. All responses and questions must be emailed to David Romley, Contract Specialist via electronic mail at contact@example.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 certification in the System for Award Management (SAM) through sam.gov. Reference: 75N91022Q00064 on all correspondence.