Notice of Intent to Award on a Sole Source Basis, No Quotes Required-NCATS Acquisition of RFP+ CELLvo Cord Blood Endothelial Cells

Notice ID:

22-001443

Department/Ind. Agency:

HEALTH AND HUMAN SERVICES, DEPARTMENT OF

Sub-tier:

HEALTH AND HUMAN SERVICES, DEPARTMENT OF

Sub Command:

NATIONAL INSTITUTES OF HEALTH NCATS

Office:

NATIONAL INSTITUTES OF HEALTH NCATS

All Dates/Times are:

(utc-05:00) eastern standard time, new york, usa

Updated Published Date:

(utc-05:00) eastern standard time, new york, usa

Original Published Date:

0000-00-00 00:00:00

Original Response Date:

dec 27, 2021 10:00 am est

Inactive Policy:

15 days after response date

Original Inactive Date:

jan 26, 2022

Initiative:

• None***--***

Original Set Aside:

8(a) sole source (far 19.8)

Product Service Code:

q301 - medical- laboratory testing

NAICS Code:

238990 - all other specialty trade contractors

Original Set Aside:

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE ORDER AND NOT A REQUEST FOR QUOTATIONS. The National Center For Advancing Transltional Sciences (NCATS), Rockville, MD intends to negotiate on a sole source basis and issue an order with StemBioSys, Inc..under the authority of Federal Acquisition Regulation (FAR) 13.106-1(b). Only one responsible source and no other supplies or services will satisfy agency requirements. This purchase is for Lab Testing Services, RFP+ cord blood Endothelial progenitors. Passage 1 cells will be sent to a specialized cell service provider for RFP transduction with an integrating vector to allow for expression regardless of time in culture or passage. Time for transduction is estimated to be up to 4 weeks. Following transduction, RFP positive cells will be expanded by SBS up to Passage 6 using CELLvo Matrix technology. RFP Positive CELLvo Cord Blood Endothelial Cells will be cryopreserved in BioLife CryoStor® Freezing Solution (500K cells/vial). Expansion time is estimated to be approximately 4 weeks. QC will follow expansion and is estimated at an additional 2-3 weeks. RFP-CELLvo™ hCB-EPCs are expressing vascular markers of CD31, CD105, and vWF. RFP-CELLvo™ hCB-EPCs are uniquely capable of clonal expansion. RFP-CELLvo™ hCB-EPCs display increased angiogenesis in vessel formation assay. RFP-CELLvo™ hCB-EPCs exhibit a more pro-angiogenic paracrine profile. RFP-CELLvo™ hCB-EPCs exhibits endothelial colony formation. RFP-CELLvo™ hCB-EPCs has been confirmed to make 3D tube formation in fibrin based hydrogel. RFP-CELLvo™ hCB-EPCs has been confirmed to maintain 3D tube construct for several weeks of long term culture. RFP-CELLvo™ hCB-EPCs has been confirmed to maintain 3D tube construct for several weeks of long term culture. Award is subject to approval of the Sole Source Justification. This notice of intent is not a request for competitive proposals or quotations; however, an interested party may submit a statement of capabilities if they believe they can meet the above requirement. The statement of capabilities must be submitted in writing and contain sufficient detail to allow the Government to determine if the party can provide the requirement. A determination by the Government not to compete this proposed action based upon responses to this notice is solely with the discretion of the Government. All responses must be received within 10 days from the date of publication of this synopsis. Information received will normally be considered for the purpose of determining whether to conduct a competitive procurement. If no affirmative responses are received within 10 days of this notice, an award will be made to StemBioSys, Inc. The NAICS Code/Size is 238990 /16.5M. This procurement is to be processed using Simplified Acquisition Procedures. There is no solicitation package available. No faxed documents will be accepted. For any questions regarding this announcement, please contact Robert McFarland via email: mcfarlar@mail.nih.gov, or Brian Lind via email: brian.lind@nih.gov

6701 DEMOCRACY BLVD

BETHESDA , MD 20892

USA

Primary Point of Contacts:

Robert L McFarland