Gene Therapy Reagent for Transfusion Medicine

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 government intends to award a fixed price purchase order with one twelve (12) month base period to Clontech Laboratories, Inc., San Francisco, CA 94145-0794. The Department of Transfusion (DTM) at National Institutes of Health (NIH) Clinical Center (CC), Bethesda, MD has a requirement to procure the below supply and quantity: Item Number: T201 or equivalent if upgraded product Description: RetroNectin (GMP)-2.5mg Unit of Issue: EA Quantity: it is estimated that the delivered quantity is 80 kits annually. The government reserves the right to increase quantities pursuant to FAR 52.217-6, Option for Increased Quantity. The total value of the contract will not exceed the simplified acquisition threshold. The CC is a clinical research hospital providing medical services for patients participating in human research protocols of the NIH. The CC provides patient care facilities and services for clinical investigations by the NIH Institutes, research in related areas, and other training programs. The CPS is responsible for the manufacture of human cells and tissue-based products utilized in phase Ml clinical protocols for transplantation, adoptive immunotherapy and gene therapy conducted in the Clinical Center at the NIH. Cell processing procedures are tailored to each of the 30 or more different patient-care clinical research protocols supported. Clontech is the only US distributor of clinical grade RetroNectin which had been used (via foreign manufacturer Takara) in all gene therapy based clinical trials worldwide. It is used in preparation for treatments for patients with Deficient Severe Combined Immunodeficiency (SCID) enrolled in FDA approved protocols. The protocols are as follows: NHLBI 12-C-00112, NHGRI Il/007/IND 150141, NIAID protocol 01HGO189/IND 8556. It is also used in I-DA approved protocol for NCI's treatment of patients with Acute Lymphocytic Leukemia (ALL) H I2-C-0112/1ND14985. It has been shown that coating culture vessels with RetroNectin improves transduction efficiency facilitating the interaction between cells and retroviral vector. Transduction efficiency is the measurement of the number of cells that has been infected by a viral construct containing the protein one would want their cells to express. The less the cells expressed regarding the protein in tile case of our process, the less they work once infused into patients. The methodology was designed, established and validated using the reagent. The manufacturing process was submitted, reviewed and approved by FDA. If RetroNectin is not used it would mean that the process would have to go before the FDA regulatory agency for re-approval as no substitutions or deviations are otherwise permissible. Additionally this could prove life threatening to the patient. This acquisition is being conducted under the authority of the FAR Subpart 13.106-1(b). Interested concerns capable of providing the same or similar products or services as described in this notice may submit a capability statement outlining their capabilities. Information received will be evaluated for the purpose of determining whether to conduct a competitive procurement. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. A 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. Each response should include the following Business Information: a. DUNS. b. Company Name, address, POC, Phone and Email address c. Current GSA Schedules or NAICS codes appropriate to this Award. d. Type of Company (i.e., small business, 8(a), woman owned, HubZone, veteran owned, etc.) as validated in System For Award Management (SAM). All offerors must register on the SAM located at http://www.sam.gov/portal/SAM/#1 e. Capability Statement Comments to this announcement, referencing this posting number, may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Andre Moody, Contract Specialist, amoody@cc.nih.gov by the due date and time marked in this notice.