Field-Flow Fractionation Multi-Angle LIght Scattering (FFF-MALS) System

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR-RFO) format in FAR 12.201-1 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 FDA-OC-2026-132553. This requirement is issued as a request for quotation (RFQ).The solicitation is issued as Full and Open Competition. The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC-2026-01, Effective 03/13/2026. The associated North American Industry Classification System (NAICS) Code 334516 with a small business size standard of 1,000 employees. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the requirements herein. A table list of line item number(s) and items, quantities, and units of measure can be found in the sections listed below in the solicitation. Description of Requirement BACKGROUND The National Forensic Chemistry Center (NFCC) in the Office of the Chief Scientist, Office of Specialty Laboratories & Enforcement Support, requires the purchase of one (1) Field-flow fractionation Multi-Angle Light Scattering (FFF-MALS) system which includes the ability to perform Size Exclusion Chromatography. The FFF-MALS and Size Exclusion Chromatography Multi-Angle Light Scattering/Refractive Index/Ultraviolet (SEC/MALS/RI/UV) instrument will be utilized to characterize molecules through the determination of molecular mass, hydrodynamic radius, polydispersity, and concentration. Determination of these biophysical properties beyond what is currently possible within the NFCC, would aid in determining sample stability and authenticity. Furthermore, this instrument can be used to characterize proteins, peptides (such as GLP-1), monoclonal antibodies, vaccines, and polymers. SEC/MALS/RI is routinely utilized in the pharmaceutical industry for characterization of biomolecules and vaccines. Acquisition of the MALS/RI/UV detectors would result in the ability to analyze classes of molecules/vaccines, including macromolecules, lipid nanoparticles, proteins, aggregates, and high-molecular-weight polymers, that cannot currently be analyzed at the NFCC and allow the NFCC to implement methodologies currently used in the pharmaceutical industry. It would also expand the capabilities within the NFCC to be more prepared to analyze large molecule therapeutics and biologics. This will not only enable the analysis of forensic and regulatory samples but will also support the development of new methodology for the NFCC and FDA. OBJECTIVE To procure One (1) Field-flow fractionation Multi-Angle Light Scattering (FFF-MALS) System with Size Exclusion Chromatography Multi-Angle Light Scattering/Refractive Index (SEC/MALS/RI) and variable wavelength Ultraviolet detection capability. The system must meet or exceed the following requirements: SCOPE OF REQUIREMENTS I. Minimum Performance Requirements/Salient Characteristics All of the following system requirements are minimum requirements. Equivalent requirements that differ from these minimum requirements shall be justified by the proposing vendor and evaluated by the NFCC prior to purchase. The Field-flow fractionation system shall have all new components, include all necessary hardware and electronics for liquid handling, flow control, sample separation, data acquisition and all necessary parts and software to operate with the following specifications: Supports flow rate of at least 5 mL/min. Allows regulation of cross flow in a range of at least 0.03-5 mL/min (i.e., range may go lower than 0.03 mL/min or higher than 5 mL/min, but must cover this range at a minimum). Instrument and channels must be compatible with both aqueous and organic solvents. Ability to regulate temperature of FFF channels. Detector flow rate control with a precision of 0.1% or better. Automated switching mode between FFF and SEC columns between injections. The UV Detector shall have all new components, and all necessary parts and software to operate with the following specifications: Variable wavelength UV detector. Dual wavelength (2 selectable channels) with a range of at least 190-700 nm. Noise Level ≤5 µAU. The Refractive Index Detector shall have all new components, and all necessary parts and software to operate with the following specifications: Dynamic Range of at least 12,000,000:1. dRI Range of at least -0047 to +0.0047 RIU. dRI Sensitivity of at least: ±7.5 x10e-10 RIU. The Multi-angle Laser Light scattering detector shall have all new components, and all necessary parts and software to operate with the following specifications: At least 18 unique measurement angles. Molar Mass Range of at least 200 Da to 1 GDa (i.e., range may go lower than 200 Da or higher than 1 GDa, but must cover this range at a minimum). Molecular Size Range of at least 10 nm to 500 nm (i.e., range may go lower than 10 nm or higher than 500 nm, but must cover this range at a minimum). The sensitivity of the MALS instrument must support quantifying the molar mass of an injection of 10 ng of 100 kDa polystyrene in THF mobile phase on standard GPC, to an accuracy of 5% and precision of 2% or better. The MALS instrument must provide, or be field-upgradeable to provide, a Dynamic Light Scattering detection module (DLS is also known as QELS or PCS). The MALS instrument must be equipped with a rear laser monitor that measures the intensity of the laser beam prior to entering the flow cell, in order to calculate any necessary compensation to the scattering signal for laser source intensity fluctuations and drift related to ambient temperature changes, laser device aging, dust or any other mechanism. This rear monitor ensures co…