Inactive

Wilson Wolf G-Rex500M Product Service Code: 6515-Medical and Surgical Instruments, Equipment, and Supplies NAICS Code: 339112-Surgical and Medical Instrument Manufacturing Place of Performance: Nation... Wilson Wolf G-Rex500M Product Service Code: 6515-Medical and Surgical Instruments, Equipment, and Supplies NAICS Code: 339112-Surgical and Medical Instrument Manufacturing Place of Performance: National Institutes of Health Clinical Center Center Drive Bethesda, MD 20822 POTS: 24-004817 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, Office of Purchasing and Contracts on behalf of Department of Transfusion Medicine, Center for Cellular Engineering intends to award a firm fixed priced award on a sole source basis to Wilson Wolf Manufacturing to supply G-Rex500M bioreactors. L/I-0001 Description: G-Rex500M-CS (2-pack box) G285500-CS-Quantity 6 Wilson Wolf Manufacturing is the original equipment manufacturer of the G-Rex System and the sole supplier of its reagents and supplies. The standalone bioreactors have been approved and qualified for the use in Food and Drug Administration (FDA) approved protocols at the National Institutes of Health, Center for Cellular Engineering. The Center for Cellular Engineering manufactures cell-based therapies for patients who either have no or have exhausted all other standard treatment options. The manufacturing operations are regulated by the Current Good Manufacturing Practices (cGMPs) as mandated by the FDA in 21 CFR 210, 211, 600 and 1271. The Food and Drug Administration (FDA) mandates that critical reagents and materials used in the manufacturing, processing, and testing of drug products must be validated to ensure that a consistent, safe, and high-quality product is manufactured. The Center for Cellular Engineering has a rigorous validation program that demonstrates that materials meet the high standards the FDA expects of materials used for patient manufacturing. Products cannot be simply substituted in manufacturing processes without confirmation through validation that the products are comparable. These validations are costly and time consuming. As a consequences validation of alternate products would introduce delays to fully as material is validated and this will cause delays to patient treatments. 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 may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government. Comments to this Announcement: Comments to this announcement, referencing this posting number on the email subject line, may be submitted to the 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 Monday, February 19, 2024, by 12:00 pm Noon EST Local Time marked in this notice.