Inactive

PRE-SOLICITATION NOTICE NOI-NIAID-2119230 NAICS – 325414, Biological Product Mfg This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAI... PRE-SOLICITATION NOTICE NOI-NIAID-2119230 NAICS – 325414, Biological Product Mfg This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with Life Technologies Corporation, Carlsbad, CA to procure the following DNA sample preparation kits: resDNASEQ Quantitative CHO DNA Kit with PrepSEQ Residual DNA Sample Preparation Kit Manufacturer: Thermo Fisher Scientific Catalog No: 4413713 Quantity: 15 res DNASEQ Quantitative E. coli DNA Kit with PrepSEQ Residual DNA Sample Preparation Kit Manufacturer: Thermo Fisher Scientific Catalog No: 4460366 Quantity: 5 The PrepSEQ Residual DNA Sample Preparation Kit, resDNASEQ Quantitative CHO DNA Kit, and resDNASEQ Quantitative E. coli DNA Kit are all needed to continue Host Cell DNA (HCD) sample support, pre-qualification, and tox testing within the Analytical Development group at VPP. The PrepSEQ Residual DNA Sample Preparation Kits are propriety HCD kits designed and optimized by Thermo Fisher specifically for extracting residual DNA from in[1]process and drug substance samples for use on the propriety KingFisher magnetic particle automation platform, which is utilized at VPP and VCMP. The resDNASEQ CHO and E. coli DNA qPCR kits contain proprietary primer/probe mixes optimized for sensitivity and host cell specificity for residual host cell DNA quantitation, as well as a proprietary PCR master mix and necessary assay standards. The PrepSEQ and resDNASEQ kits are designed to work together to overcome limitations of traditional methods, by combining high-recovery sample preparation on an automated platform with sensitive and specific TaqMan-based qPCR quantitation of residual DNA. These specific kits are specified in developed and approved method SOPs for Characterization and Release Assays for multiple projects at the VPP/VRC, with methods also transferred and in-use at the VCMP. Any changes to these kits may cause the assays and results coming from these assays to be void, as well as threaten tight project timelines. These kits are required to quantify residual host cell DNA in order to show impurity clearance and demonstrate safety of the therapeutic and vaccine candidates. There is no other feasible assay option due to the amount of time and money already spent developing and validating the Thermo Fisher PrepSEQ and resDNASEQ kit methods for use at the VPP and VCMP, as well as tight project timelines to support in-process development and tox testing. The Place of performance is 9 West Watkins Mill Road, Gaithersburg, MD 20878. The statutory authority for this sole source requirement is 41 U.S.C. 1901 (e) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide comparable services may submit a capability statement that will be considered by email (subject line to reference NOI-NIAID-2119230) to Dana Monroe at dana.monroe@nih.gov, by Monday, March 28, 2022 by 5:00pm pacific time. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.