Inactive

Notice of Intent: Gemini Bio-GemCell TM Plus Xeno free Reagents NAICS Code: 325414- Biological Product (except Diagnostic) Manufacturing (small business size standards Average Number of Employees $125... Notice of Intent: Gemini Bio-GemCell TM Plus Xeno free Reagents NAICS Code: 325414- Biological Product (except Diagnostic) Manufacturing (small business size standards Average Number of Employees $1250) PSC/FSC: 6550- In Vitro Diagnostic Substances, Reagents, Test Kits and Sets Place of Performance: Bethesda, MD 20892 POTS: 24-013197 Description: This is a notice of intent, not a request for a quotation. A solicitation document will not be issued, and quotations will not be requested. The National Institutes of Health, Clinical Center, Office of Purchasing and Contracts on behalf of the Center for Cellular Engineering intends to issue a firm-fixed priced award to Gemini Bio located at 920 Stillwater Road in West Sacramento in the state of California on a sole source basis to supply of GemCell™ Plus Xeno-Free reagents. Line-Item Number: 0001 Description: GemCell™ Plus Xeno-Free. Product No. 100-912-100 Quantity 200 The Center for Cellular Engineering is responsible for manufacturing human cell and tissue-based products used in phase I/II clinical trials for transplantation, adoptive immunotherapy, and gene therapy at the NIH Clinical Center. These cell processing procedures are customized for over 30 different patient-care clinical research protocols. The Center for Cellular Engineering relies on Gemini Bio human AB serum in preparing cellular therapies for several Food and Drug Administration approved protocols. Without this serum, the Center for Cellular Engineering cannot culture cells, leading to the potential closure of many protocols and leaving numerous patients untreated. Although similar materials are available from other sources, there is significant lot-to-lot variability. The Center for Cellular Engineering has tested specific lots from Gemini Bio to ensure compatibility with current manufacturing procedures, and Gemini Bio has been approved by the Center for Cellular Engineering Quality Assurance Department for use in these protocols. Switching to another vendor would require requalification of the processes, which would be both costly and time-consuming for the government. Moreover, the delays in requalifying this material could result in treatment delays for patients, potentially affecting their clinical outcomes and the interpretation of the efficacy of the treatments under evaluation in clinical trials. Therefore, only Gemini Bio is the only source capable of fulfilling this requirement. This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, Subpart 13.106-1(b)(1). For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. Interested Parties: Interested parties capable of providing the same or similar products or services described in this notice may submit a capability statement outlining their capability to perform the described work. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. The determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Comments: Comments to this announcement, referencing this posting number, may be submitted to the CC, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Sheri Eiri, Contract Specialist, sheri.eiri.nih.gov by the due date September 8, 2024 by 12:00 pm Noon EST and time marked in this notice. No phone calls will be accepted.