SAM #75F40126Q134650

FDA CBER Solicitation for Integrated Analytical System for Gene Therapy Characterization

The FDA Center for Biologics Evaluation and Research (CBER) Gene Therapy Immunogenicity Branch is seeking an integrated analytical system for advanced characterization of gene therapy products. - Government Buyer: - Food and Drug Administration (FDA), CBER Gene Therapy Immunogenicity Branch - OEMs and Vendors: - Unchained Labs (Stunner AF platform specified as example; "or equal" alternatives accepted) - Products/Services Requested: - Integrated, multi-attribute analytical system (Unchained Labs Stunner AF or equivalent) - Part number: 700-3003 - Quantity: 1 - Capabilities: UV/Vis, RADLS, fluorescence; measures genome packaging efficiency, aggregation, viral genome concentration, and capsid concentration - Supports up to 96 samples per run from a single 2 L sample - Installation and in-person operator training (instrument operation, experimental setup, basic data analysis) - 12-month manufacturer's warranty - Four option years for post-warranty service agreements (each includes preventive/corrective maintenance, software/firmware updates, technical support) - Unique/Notable Requirements: - System must be able to characterize both Adeno-Associated Virus (AAV) vectors and Lipid Nanoparticles (LNPs) - Rapid maintenance response (corrective maintenance within 3 business days) - Unrestricted solicitation; "or equal" products permitted - Delivery, installation, and training required within 100 days of contract award

Description

See attached combined synopsis/solicitation.

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