Description

This is a notice of intent to sole source for cGMP cell bank storage. This notice is not a request for competitive quotes. BioReliance Solutions is the service provider. However, any available small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. A determination by the Government to compete this proposed award based upon responses to this notice is solely within the discretion of the Government. A solicitation document will not be issued and quotations will not be requested. The Center for Disease Control and Prevention intends to award a fixed price purchase order, on a firm fixed price sole source award basis to provide cGMP cryostorage to four Influenza Division cell banks: the MCB and WCB for three types of qualified cells: Vero cells, MDCK cells, and Expi293F cells for National Center for Immunization and Respiratory Disease (NCIRD). The purpose of this acquisition is to ensure the continued cGMP-compliant cryogenic storage, maintenance, and secure management of CDC-qualified Master Cell Banks (MCBs) and Working Cell Banks (WCBs) that support the development and production of CVVs. This effort involves coordination between the Centers for Disease Control and Prevention (CDC) Influenza Division and a qualified contractor capable of meeting all applicable FDA, cGMP, and regulatory requirements for the long-term storage of regulated biological materials. The scope of this contract is the continued cryogenic storage and maintenance of CDC's qualified cell banks under cGMP conditions. The contractor shall store the designated Master Cell Banks (MCBs) and Working Cell Banks (WCBs) for the Vero, MDCK, and Expi293F™ cell lines in validated continuously monitored liquid nitrogen or colder cryogenic systems. The contractor shall ensure long-term viability and integrity throughout the period of performance. The overall objective is to maintain uninterrupted, regulatory-compliant cryostorage services for multiple CDC cell substrates, including Vero, MDCK, and Expi293F™ cell lines, all of which are essential for generating seasonal and pandemic influenza CVVs. The Contractor shall ensure compliance with all applicable FDA regulations, cGMP requirements, provide secure, monitored, and validated cryogenic storage conditions, security controls, and documentation standards necessary to preserve material integrity and support FDA-regulated vaccine manufacturing processes. The contractor must be capable of supporting both current and future programmatic needs, ensuring that CDC's characterized and qualified cell banks remain viable, traceable, and immediately accessible for vaccine manufacturing workflows. This acquisition is being conducted using policies unique to the …

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• Attachment 1