The FDA is seeking information from small business sources capable of providing a Nucleofection system (Lonza 4D or equal) to support ongoing research involving the transfection of various cell lines. The system must meet specific technical requirements, including the ability to deliver DNA, RNA, and proteins into cell lines and human primary cells, and achieve post-transfection cell viability of up to 90%.
Key features of the system include:
• The transfection system shall be a Nucleofection System capable of delivering DNA, RNA, and proteins into cell lines and human primary cells.
• The transfection system shall utilize conductive polymer (metal-free) electrodes to eliminate toxic metal ion release during electrical discharge.
• The system shall process 2 × 10⁴ to 1 × 10⁷ cells per reaction and shall accommodate low-yield, rare primary patient samples with a minimum operational cell threshold of no more than 2 × 10⁴ cells per single reaction volume.
• The instrument shall achieve post-transfection cell viability of up to 90% under manufacturer-recommended operating conditions.
• The instrument shall utilize a specialized substrate-driving electrical waveform to propel DNA, RNA, and proteins directly across the nuclear membrane of non-dividing cells.
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