Lonza 4D or equal nucleofection system

75F40126Q134795 1 of 14 This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) RFO Part 12, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation number is 75F40126Q134795. This solicitation is issued as a Request for Quote (RFQ). This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at https://www.acquisition.gov/far-overhaul. The associated North American Industry Classification System (NAICS) code for this acquisition is 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1,000 employees. This requirement is solicited full and open; any sized business may submit a quote. Schedule of Supplies or Services and Prices/Costs. Prices shall be inclusive of shipping, onsite installation, user training (familiarization) and any applicable tariff charges Item # Description Est. QTY Unit of Measure Unit Price Extended Price 1 Lonza 4D-Nucleofector Core Unit, Item # AAF-1003B, or equivalent 1 Ea $___________ $___________ 2 4D-Nucleofector X Unit, Item # AAF- 1003X, or equivalent 1 Ea $___________ $___________ Grand Total: $ ________________________ GSA Contract Number: __________________ (if applicable) Requirement The Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP), Office of Plasma Protein Therapeutics (OPPT), Division of Hemostasis (DH), Hematosis Branch requires a Lonza 4D Nucleofection system (or equal) to support ongoing research involving the transfection of various cell lines, including HEK293, CHO, and Huh7. The lab’s studies involve the introduction of different DNA constructs (e.g., ADAMTS13, F9, F8, and their variants in Flp-In– based vectors) to evaluate the effects of nucleotide sequence variation on protein expression, function, and immunogenicity. In addition, this work supports investigations utilizing CRISPR/Cas9 gene-editing technology. It is essential that the selected system provides highly efficient transfection across a broad range of cell types, particularly human primary cells such as dendritic cells, which are known to be difficult to transfect. The system must also ensure minimal cytotoxicity to preserve cell viability and maintain experimental integrity. Given the high cost and limited availability of these primary cells, the ability to achieve reliable transfections using low cell numbers is critical. Furthermore, consistent and high transfection efficiency is necessary to ensure reproducibility and robustness of results for both regulatory and mission-related research conducted within CBER’s division. The Lonza Nucleofector system meets all these requirements, offering optimized protocols for a wide variety of cell types, including hard-to-transfect primary cells, while maintaining high efficiency and -- 1 of 14 -- 75F40126Q134795 2 of 14 low cytotoxicity. Its ability to perform effective transfections with minimal cell input makes it particularly well-suited for the lab’s research needs. Any proposed equipment/systems shall meet or exceed the minimum requirements/specifications outlined below to be deemed technically acceptable: Minimum Requirements/Specifications: 1. The transfection system shall be a Nucleofection System capable of delivering DNA, RNA, and proteins into cell lines and human primary cells. 2. The transfection system shall utilize conductive polymer (metal-free) electrodes to eliminate toxic metal ion release during electrical discharge. 3. 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. 4. The instrument shall achieve post-transfection cell viability of up to 90% under manufacturer- recommended operating conditions. 5. 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. 6. The system shall contain an onboard software database with factory-preprogrammed, manufacturer-validated pulse protocols specifically calibrated for primary human dendritic cells Installation, Training and Additional System Requirements: 1. The system must be a newly manufactured unit, not used and refurbished or previously used for demonstration. 2. Offered systems shall be a turn-key solution i.e., the Contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need. 3. The Contractor shall provide all labor, travel, and tools to install the equipment at the address provided below, to include shipping. The system shall be delivered with all necessary supplies, accessories, and standard kits required for installation, start-up, and qualification tests. 4. Installation shall be conducted by factory certified service personnel, who shall demonstrate that all modules start up properly, are correctly installed and connected. 5. The system and associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and troubleshooting for the system and controlling software. All manuals and documentation shall be provided in hard copy and/or electronic format. 6. Upon acceptance of the system, the Contractor shall provide on-site operator training/familiarization for 3-5 users. Such familiarization shall include system operations, calibration, optimization, troubleshooting and basic operational maintenance procedures. 7. Systems shall be warranted for a minimum of one (1) year from FDA accep…