SAM #96005

CDC Sole Source Notice: Real-Time PCR Primer and Probe Kits from BioSearch Technologies INC

This notice announces the CDC's intent to award a sole source contract for real-time PCR primer and probe kits. - Agency: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS) - Sole source vendor: BioSearch Technologies INC - Requirement: Manufacture, assembly, quality control, packaging, and delivery of real-time PCR primer and probe kits - Kits must be commercially manufactured, dried or lyophilized - Must use Black Hole Quencher (BHQ) probe chemistry for compatibility with validated assay designs - Compliance with FDA Quality System Regulations (21 CFR 820) is required - Secure handling of sensitive primer and probe sequence information is mandatory - Scope includes: - Pilot and full-scale production - Quality assurance, kit assembly, labeling, packaging, and delivery - All work performed at contractor’s facilities unless otherwise authorized - Detailed requirements to be specified in individual task orders - Commercial opportunity: Sole source procurement; no competitive solicitation anticipated - OEM highlighted: BioSearch Technologies INC - Potential competitors: Other manufacturers of PCR kits with BHQ chemistry and FDA QSR compliance (e.g., Thermo Fisher Scientific, Integrated DNA Technologies) - Estimated contract value not specified - Period of performance: Defined at the task order level; no specific dates provided

Description

the Contractor shall manufacture, assemble, perform quality control, package, and deliver real-time polymerase chain reaction (PCR) primer and probe kits in accordance with Government-approved technical specifications, manufacturing specifications, applicable regulatory standards, and individual delivery orders issued under the BPA. The scope includes pilot production, full-scale production, quality assurance activities, labeling, packaging, and delivery of approved kits. 

The required supplies consist of commercially manufactured, dried or lyophilized PCR primer and probe kits that meet Government-defined technical specifications. These specifications include the use of Black Hole Quencher (BHQ) probe chemistry to maintain compatibility with validated assay designs, compliance with Food and Drug Administration (FDA) Quality System Regulations (21 CFR 820), and the capability to securely handle sensitive primer and probe sequence information.

The contractor shall provide end-to-end production, including primer and probe synthesis, pilot batch production, full-scale manufacturing, quality assurance, kit assembly, labeling, packaging, and delivery of finished kits.

Detailed technical, quality control, security, and kit assembly requirements are described at the task order level and will be incorporated by reference in applicable individual task orders. Compliance with such specifications is mandatory when invoked by task order. All work shall be performed at the Contractor’s facilities unless otherwise authorized by the Contracting Officer.

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