Notice of Intent to Sole Source - BioSearch Technologies INC. 96005

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.