Inactive

Takara Bio USA, Inc RetroNectin® GMP grade reagent. NAICS Code: 325413-In Vitro Diagnostic Substance Manufacturing (Small Business Size Standards Average Number of Employees 1,250) PSC/FSC: 6550-In Vi... Takara Bio USA, Inc RetroNectin® GMP grade reagent. NAICS Code: 325413-In Vitro Diagnostic Substance Manufacturing (Small Business Size Standards Average Number of Employees 1,250) PSC/FSC: 6550-In Vitro Diagnostic Substances, Reagents, Test Kits and Sets Place of Performance: Bethesda, MD National Institutes of Health Clinical Center 10 Center Drive Building 10, Room TBD Bethesda, Maryland 20892 POTS: 24-002687 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 (NIH), Office of Purchasing and Contracts on behalf of the Center of Cellular Engineering intends to negotiate and award a contract without providing for full and open competition (including brand-name) to Takara Bio USA, Inc. on a sole source basis for the purchase of RetroNectin® GMP grade reagent. Line Item-0001 Description RetroNectin® GMP grade Product No. T202 UoM Vial Quantity 30 Proposed Contractor: Takara Bio USA Inc. 2560 Orchard Parkway San Jose, CA 95131-1033 The Center of Cellular Engineering is an AABB accredited cellular therapy laboratory whose central mission is to provide services to support more than 50 intramural clinical trials. These services include (1) development, evaluation, and validation of investigational new drugs (INDs) for cellular therapies and (2) manufacture of cellular therapy products for approved clinical trials. Most of these trials are early phase not intended to result in the development of a commercial product. The Center of Cellular Engineering operates a core facility for the manufacture, storage, and distribution of cellular therapy products. The Center of Cellular Engineering manufactures cellular therapy products from more than 800 collections from patients or healthy donors per year. The products manufactured by the laboratory are used to treat NIH CC patients with cancer, hematological malignancies, marrow failure, genetic immune disorders, and autoimmune diseases. All products are manufactured using good manufacturing practices (GMP). The NIH protocols are institutional review board (IRB) approved and in the case of INDs, approval by the US Food and Drug Administration (FDA) for treatment of human subjects. Each subject must consent to participate in a NIH Clinical Research Study. The Center of Cellular Engineering used Takara's RetroNectin during the manufacturing process of clinical T-cells. This includes but is not limited to: Gene Transduction for X-Linked Severe Combined Immunodeficiency (XSCID), CAR 19 T-cells, Preparation of Autologous Transduced T Lymphocytes Expressing Anti-GD2 Chimeric Antigen Receptor (GD2 CAR), and Transduced T-cells expressing B-cell maturation antigen. 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, 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 December 23, 2023 and 12:00 pm EST time marked in this notice.