Saint Gobain/ KryoSure Bags and KryoSure Overwrap Pouches for Cellular Therapy

The National Institutes of Health (NIH) intends to award a fixed priced purchase order on a sole source basis to  Saint-Gobain Performance Plastics Corporation,  Solon, OH, 44139-3528 to procure Saint Gobain/ KryoSure Bags and KryoSure Overwrap Pouches.  The Center for Cellular Engineering (CCE) is an AABB accredited cellular therapy laboratory whose central mission is to provide services to the NIH Institutes 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. The majority of these trials are early phase (I/II) trials not intended to result in the development of a commercial product. To provide these services, CCE operates a core facility for the manufacture, storage, and distribution of cellular therapy products. CCE 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.CCE uses these selected materials, validated and tested, in the preparation for treatment of patients on clinical trials currently under INDs approved by the FDA.  An IND prohibits the substitution of any reagent, material or process named in the original protocol submissions.  This purchase is to procure KryoSure Bags (Catalog # 2PF-0060) and KryoSure Overwrap Pouch (Catalog # OP-0061) from Saint-Gobain, both manufacturer and distributor. These bags are used for the cryopreservation of cellular therapy products. They are manufactured using a proprietary laser welding process, permitting a wide range of shapes and sizes of bags, as well as allowing manufacturer/vendor to make bags with an internal volume as small as 1ml, and as large as 50 liters. The FEP (Fluorinated Ethylene Propylene) film used in the bags and overwraps is made from a unique, very high molecular weight FEP resin and uses proprietary film extrusion processes. While there are other companies that manufacture FEP bags, they do not use the processes used, nor the range of sizes and shapes manufactured.  In addition, the film used by others, is manufactured by a different extrusion process. The bags are considered Class I Medical Devices and are made at an FDA registered and inspected facility.134 QTY OF 2PF-0060 BAGS AND242 QTY OF 0P-0061 OVERWRAPS IS NEEDED.This acquisition is being conducted under the authority of the FAR Subpart 13.106-1(b)(i), Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available. 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. 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. The total dollar value of this purchase order shall not exceed the SAT at $250,000.00.Each response should include the following Business Information:a. DUNS.b. Company Name, address, POC, Phone and Email addressc. 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/#1e. Capability StatementComments to this announcement 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 Malinda Dehner, Contract Specialist, dehnerm@cc.nih.gov by the due date and time marked in this notice