Purchase of Assorted Cell Culture Medium, Substrate, and Supplements

PRE-SOLICITATION NOTICE OF INTENT NON-COMPETITIVE (HHSN-NIH-NIDA-18-442) INTRODUCTION PURSUANT TO FAR Subpart 5.2-Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT ACTION. THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), on behalf of the National Center for Advancing Translational Sciences (NCATS) intends to negotiate and award a contract/purchase order for "Purchase of Assorted Cell Culture Medium, Substrate, and Supplements" with: Life Technologies Corporation 5791 Van Allen Way Carlsbad, CA 92008 NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code: - 325413 - In-vitro Diagnostic Substance Manufacturing - Size Standard: 1250 employees REGULATORY AUTHORITY The resultant contract/purchase order will include all applicable provisions and clauses of the Federal acquisition Regulation (FAR) in effect through the Federal Acquisition Circular (FAC) 2005-99 (dated June 15, 2018). STATUTORY AUTHORITY This acquisition is conducted as non-competitive under the authority of 41 U.S.C. 253(c)(1) under provisions of the statutory authority of FAR Subpart 6.302-1 - Only one responsible source and no other supplies or services will satisfy agency requirements. DESCRIPTION OF REQUIREMENT Project Description, Background and Purpose 1. Ongoing research projects in SCTL focus on understanding molecular mechanisms regulating stem cell pluripotency and their multi-lineage differentiation capabilities with a focus on defining optimum culture conditions for maintaining pluripotent stem cells and their conversion to homogeneous and mature population of differentiated cells. To achieve these aims, SCTL performed rigorous internal tests of a variety of stem cell culture systems from vendors to find those that meet our specific requirement, including supporting stem cell pluripotency maintenance, multi-lineage differentiation and 3-D culture. Any cell culture media used in this context must meet specific measurements of purity and consistency from batch to batch to provide consistent cell growth and viability. Our research has used numerous batches of cells grown using "Essential 8" (from Life Technologies, Inc.) and the result was consistent and predictable growth resulting in successful assays performed at NIH NCATS. Indeed, we have used Life Technologies cell culture medium for the majority of cells in our assays since its inception. Re-optimization of all existing assays would need to be performed if another manufacturer's medium were to be introduced, and would therefore incur tremendous costs, time and material resources to the government. 2. Purchase Description/Quantities: Assorted cell culture medium, substrate and supplements, including: a. One hundred (100) x A1516401 Essential 6TM Medium b. Two hundred (200) x A1517001 Essential 8TM Medium c. One hundred (100) x 10565018 DMEM/F-12, GlutaMAXTM supplement d. One hundred fifty (150) x 12587010 B-27TM Supplement (50X), minus vitamin A e. Hundred (100) x A1370701 CTSTM (Cell Therapy Systems) N-2 Supplement f. Seven hundred (700) x A14700 Vitronectin (VTN-N) Recombinant Human Protein, Truncated g. Ten (10) x A29249 rhLaminin-521 h. Ten (10) x 14190250 DPBS, no calcium, no magnesium i. Ten (10) x 14040182 DPBS, calcium, magnesium j. Fifty (50) x A1569601 GeltrexTM hESC-Qualified, Ready-To-Use, Reduced Growth Factor Basement Membrane Matrix k. One hundred (100) x A1895601 B-27TM Supplement, minus insulin 3. Salient characteristics: a. Xeno-free and feeder-free medium specially formulated for the growth and expansion of human pluripotent stem cells (PSCs). b. Support iPSC growth for >50 passages without any signs of karyotypic abnormalities, c. Maintain the ability of iPSCs to differentiate into all three germ line lineages. d. Reduced variability compared to existing feeder-free culture media DELIVERY SCHEDULE/PERIOD OF PERFORMANCE Three (3) separate shipments within ~6-month period; first shipment ~4 weeks after award of delivery order. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include (as applicable for services): unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations. In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by Tuesday, August 21, 2018, by 3:00pm EST and must reference number HHSN-NIH-NIDA-18-442. Responses must be submitted electronically to Bruce Anderson at bruce.anderson@nih.gov and must reference the solicitation number HHSN-NIH-NIDA-18-442, on your electronic request. FAX requests are not accepted. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."