Source Sought_RFI 2026 FFF-MALS.docx

This is a Sources Sought/Request for Information (RFI) notice for One (1) Field-Flow Fractionation Multi-Angle Light Scattering (FFF-MALS) with SEC System.

This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain market research information regarding the market availability; capability of all qualified sources to fulfill a potential requirement, and pricing information for budgeting purposes only.

This notice is issued to help determine the availability of qualified vendors technically capable of meeting this Government requirement, to determine the method of acquisition, availability of domestic sources in the United States of sufficient and reasonably available commercial product providers that are of a satisfactory quality. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes and are non-binding. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Small businesses are encouraged to respond.

The North American Industry Classification System (NAICS) Code is 423490 – Scientific Laboratory Equipment Merchant Wholesalers.

The Product or Service Code (PSC) is 6632 – Analysis Instruments, Medical Laboratory Use.

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.

Purpose NFCC regularly provides support to CDER, CBER, and various offices within the Office of Inspections and Investigations, such as the Office of Criminal Investigations and the Office of Import Operations, as well as other agencies outside of the FDA in the analysis of foods, drugs, dietary supplements, and medical products that have been suspected of being harmful to consumers. Analysis of biomolecules and larger biological samples, such as viruses and vaccines, is a critical capability of the NFCC. In the past, NFCC analysis of lipid nanoparticles encapsulating mRNA has been limited to analysis of the nucleic acids contained within the lipid nanoparticles, as NFCC currently lacks the ability to characterize particles as large as an intact lipid nanoparticle or virion. As such, it is crucial that the NFCC has an analytical platform capable of performing the sophisticated analyses required to characterize large molecules and particles. FFF-MALS is a powerful method to separate and characterize all types of analytes ranging in size from 1 nm to 1000 nm, such as gene vectors, viruses, nanodrug carriers, proteins, aggregates, polymers, and high molecular weight polymers. With FFF-MALS size distribution of these particles can be reliably determined, and with the associated MALS, RI, and UV detectors molecular size, concentration, and nucleic acid content can be determined for these samples. A use case of this is particle size and polydispersity characterization of lipid nanoparticles, such as mRNA vaccines. This could help detect potentially counterfeit or unsafe products on the market. The capabilities of an FFF-MALS system with the ability to do SEC/MALS/RI in one instrument will enable NFCC to characterize gene vectors, viruses, nanodrug carriers, proteins, aggregates, polymers, and high molecular weight polymers in multiple forensic investigations. A system that meets the performance requirements and salient characteristics described below would enhance our ability to detect and characterize these molecules and thereby enhance our ability to protect public health.

Scope The scope of this contract requires the vendor to supply 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.

Minimum Product Requirements/Salient Characteristics The following system characteristics are minimum product requirements for this potential acquisition. Equivalent requirements that differ from these minimum requirements shall be justified by the interested vendor and evaluated by the NFCC prior to purchase.

1) 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:

a) Supports flow rate of at least 5 mL/min.

b) 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).

c) Instrument and channels must be compatible with both aqueous and organic solvents.

d) Ability to regulate temperature of FFF channels.

e) Detector flow rate control with a precision of 0.1% or better.

f) Automated switching mode between FFF and SEC columns between injections.

2) The UV Detector shall have all new components, and all necessary parts and software to operate with the following specifications:

a) Variable wavelength UV detector.

b) Dual wavelength (2 selectable channels) with a range of at least 190-700 nm.

c) Noise Level ≤5 µAU.

3) The Refractive Index Detector shall have all new components, and all necessary parts and software to operate with the following specifications:

a) Dynamic Range of at least 12,000,000:1.

b) dRI Range of at least -0047 to +0.0047 RIU.

c) dRI Sensitivity of at least: ±7.5 x10e-10 RIU.

4) The Multi-angle Laser Light scattering detector shall have all new components, and all necessary parts and software to operate with the following specifications:

a) At least 18 unique measurement angles.

b) 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).

c) 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).

d) 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.

e) 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).

f) 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 consistent molar mass measurements over long and short periods.

g) The MALS instrument must be capable of operating in a cold box or cold room to perform experiments below room temperature.

h) The MALS instrument must be equipped with a forward laser monitor to measure the intensity of light transmitted through the flow cell, in order to correct the scattering signal for absorbance of the laser beam by the sample as well as diagnose the presence of bubbles or large contaminants in the flow cell.

i) The MALS instrument must provide a means of removing particles adhering to the MALS flow cell interior surfaces so as to minimize detector noise due to light scattering from these particles, and to prolong time between manual maintenance.

j) The MALS instrument must be calibrated using a uniform fluid such as toluene, commonly available with high quality and repeatability, rather than calibrated against a molar mass standard, because the latter technique depends on precise knowledge of concentration and refractive index increment of the standard in each specific solvent.

k) The MALS instrument must provide, or be field-upgradeable to provide, a batch operation option whereby one may remove the flow cell and replace it with a cuvette requiring 30 µL or less.

l) The MALS detector must be capable of user-installed upgrades with new firmware releases.

m) The MALS instrument and software must operate so as to provide a laser lifetime of ≥10,000 hours.

n) The MALS instrument must have the ability to adjust its laser intensity.

o) The MALS detector and software must provide a means of accepting external signals from a GPC, FPLC, HPLC, SEC or FFF system in order to utilize autoinject triggers and UV analog signals.

p) The MALS instrument must be field-diagnosable for failures and troubleshooting, and field-serviceable to facilitate rapid, on-site repair in case of failure.

q) The MALS instrument’s flow cell must be field-replaceable without need for optical alignment.

5) The liquid chromatography system shall have all new components, and all necessary parts and software to operate with the following specifications:

a) Pump(s) with high pressure mixing and solvent degasser.

b) Flow rate range of 0.001-5 mL/min and be adjustable in 1 µL /min increments

c) Pressure range up to 400 bar.

d) Flow rate accuracy of ± 1%.

e) Pump pressure ripple less than 1%.

f) Flow rate precision of ≤ 0.075% RSD.

g) Operable pH range of 2-12.

h) Autosampler thermostat controlled with temperature range of at least 4-40ºC.

i) Injection volume range of at least 1 µL to 1000 µL.

ii) Injection precision of ≤1% RSD.

iii) Autosampler thermostat controlled with temperature range of at least 4-40ºC.

i) Column compartment thermostat controlled with temperature range of 20-90ºC (i.e., temperature range may go lower than 20ºC or higher than 90ºC, but must cover this range at a minimum).

6) The Fraction collector shall have all new components, and all necessary parts and software to operate with the following specifications:

a) Thermostat controlled with temperature range of 5-40ºC (i.e., temperature range may go lower than 5ºC or higher than 40ºC, but must cover this range at a minimum).

b) Controlled by system software.

c) Allow for use of 2 x 48 chromatography vials or 2 x 96 well plates as collection vessels.

7) Computer system for running software responsible for instrument tuning, data acquisition, and data storage:

a) The computer system shall have all components necessary to operate the instrument with the following specifications:

a. System salient characteristics:

i. 110 Vac power cord(s).

ii. USB English keyboard.

iii. USB optical mouse.

b. Network salient characteristics:

i. One (1) or more ethernet ports dedicated for network connections.

c. Storage salient characteristics:

i. 1 TB or greater SATA hard drive.

d. Meets or exceeds minimum requirements for instrument system operation.

e. Operating system salient characteristics:

i. Windows 11 Professional 64-bit, or newer.

8) Software responsible for instrument tuning, data acquisition, and data storage:

a) The software must work seamlessly with up to five relevant online detectors.

b) The software must correct the data for interdetector band-broadening such that molar mass is displayed as being uniform across the elution volume of known monodisperse macromolecules.

c) The software must provide for the determination of molar masses and sizes in the eluting macromolecules, stating with each measured value the associated uncertainties (or error bars in graphs).

d) The software must account for changes in all relevant solvent properties, e.g. solvent refractive index or viscosity, due to changes in temperature.

e) The software must be capable of automatically selecting baseline subtraction and peak position parameters.

f) Software must be capable of controlling associated pump modules.

g) The software must be capable of accepting a blank measurement and subtracting it from the sample measurement in order to eliminate gradient baselines.

h) The software must be capable of analyzing binary conjugates such as glycoproteins, PEGylated proteins or copolymers using a three-detector method (MALS-UV-dRI).

i) The software must be capable of calculating critical quality attributes of viral vectors such as an adeno-associated virus (AAV) by both MALS-UV-dRI analyses and MALS + dual-wavelength UV analysis. These quality attributes must include the total number of viral capsid particles, relative capsid content (empty/full ratio) and percent aggregates.

j) Using a three-detector method (MALS-UV-dRI), the software must be capable of analyzing binary nanoconjugates such as LNP-encapsulated RNA, liposomes and polyplexes bearing small-molecule drugs or multi-megaDalton glycoconjugates, that all exhibit inflated UV signals due to scattering in the UV detector, by incorporating a size-dependent UV scattering correction.

k) Software capable of detecting and quantifying nucleic acid in lipid nanoparticles.

l) The software must be capable of analyzing macromolecular conformation by combining two properties such as size/molar mass, intrinsic viscosity/molar mass or rms radius/hydrodynamic radius.

m) The vendor must allow the software to be installed on at least two computers.

II. Trade and Service Specifications

· The system must be a newly manufactured unit, not used and refurbished or previously used for demonstration. Routine customer service and technical support shall be available from the vendor during the product’s lifecycle.

· A minimum of one-year warranty is required with the purchase and shall include at a minimum: coverage on all non-consumable items and parts supplied including the base instrument and any sampling accessories.

· Onsite installation and training. 3-day onsite installation and familiarization installing and testing the system and detectors. Four-day onsite training course at customer facility for up to three people including all training materials, all handouts, MALS training, hands-on training on software and hardware, sample analysis, data processing, system maintenance, and system troubleshooting.

· Free unlimited telephone, e-mail, and/or FAX technical support for one year.

III. Requirement Specific Questions Interested vendors shall submit answers to the following questions in their response to this request for information.

1. Specify support and expertise are available from the manufacturer post purchase, i.e. type of support, mode of delivery, and availability?

2. What type of warranties, discounts, and repair/maintenance services are offered?

3. What sizes/types of FFF membranes/channels are supported?

4. Describe the ease of switching between SEC and FFF modes?

5. Is the flow cell able to be cleaned by the end user? What parts require specialized expertise for routine maintenance?

6. What is the MALS detector’s dynamic range and sensitivity?

7. What are the detection limits for typical samples?

8. Do molar mass measurements require a reference to a standard known molar mass?

9. Can fractions be collected based on size, time, or signal triggers (e.g., UV/RI peaks)?

10. Is the control and data analysis software unified for FFF, SEC, MALS, and fraction collection?

11. How prevalent is the use of the instrument in peer reviewed literature? Provide a current and accurate source list of documented peer reviewed literature.

12. How is the system’s performance verified/validated?

13. How is the precision of the molar mass result calculated and presented to the user?

14. What formats/platforms can the software export raw and processed data?

15. Can the system handle both aqueous and organic solvent systems?

16. What consumables are needed (membranes, filters)? How often do membranes need replacement?

17. Are there self-diagnostic systems for leak detection or flow inconsistencies?

18. Is the system modular and upgradable (e.g., future detectors, software)?

19. Does the vendor plan ongoing development for FFF and SEC techniques?

20. Provide an overall rough cost estimate/range for this requirement.

All vendor questions pertaining to this requirement shall be submitted directly to the Contract Specialist listed below via email only. Vendor questions must be received no later than 10 A.M. ET, Friday, February 6, 2026.

Capability Statement /Information Sought

Vendors that believe they possess the capabilities of fulfilling this requirement should submit a capability statement that thoroughly documents of their ability to satisfy each of the product requirements to the Contracting Officer. Additionally, document any vendor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all requirements may be met, if applicable. Capability statements must also include the following:

· Vendor Name

· Unique Entity ID from active SAM.gov profile. Ensure the Purpose of Registration states “All Awards”

· Small Business status (small or large) as applicable to the requirement’s NAICS code 423490 – Scientific Laboratory Equipment Merchant Wholesalers and size standard in accordance with the Small Business Administration

· Physical Address

· Point of Contact information including respondent’s technical and administrative points of contact name(s), titles, addresses, telephone and fax number(s), and e-mail address(es)

The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide required sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number.

One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing.

The information submitted must list specifications that address the elements of the product requirement. Supplemental graphics and/or brochures are permitted and encouraged to be included as attachments with your response narrative.

A cover page and an executive summary may be included but are not required.

The response is limited to a ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested.

All responses to this notice must be submitted electronically to the Contract Specialist. Facsimile responses are NOT accepted.

All responses must be submitted to Andrea Howard, Contract Specialist, at andrea.howard1@fda.hhs.gov on or before Tuesday, February 10, 2026, at 11:00 A.M. ET.

Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published at www.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).