SS-75F40124Q121785-Liquid Chromatography.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY

FOR WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION

ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE

AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL

BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING

INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT OR ANY

FOLLOW-UP INFORMATION REQUESTS. NO TELEPHONE CALLS WILL

BE ACCEPTED REQUESTING AN RFQ PACKAGE OR SOLICITATION.

THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO

PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE

PROCUREMENT, IF ANY, THAT MAY ARISE FROM THIS

ANNOUNCEMENT, INFORMATION REGARDING THE TECHNICAL

POINT OF CONTACT WILL NOT BE GIVEN AND NO APPOINTMENTS

FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) has issued this sources sought announcement on behalf of the Forensic Chemistry Center (FCC) in order to determine if there are existing small business sources capable of providing one (1) liquid chromatography coupled with high resolution-accurate mass tandem mass spectrometer system (LC-HRAM-

MS/MS)

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1000 employees and believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Nina.Montgomery@fda.hhs.gov. The vendor should include information about the company and demonstrate that it can meet all of the minimum performance requirements.

BACKGROUND

The Forensic Chemistry Center (FCC) in the Office of Regulatory Affairs/Office of Regulatory Science/Office of Medical Products, Tobacco, and Specialty Labs (ORA/ORS/OMPTSLO) requires the purchase of one (1) liquid chromatography coupled with high resolution-accurate mass tandem mass spectrometer system (LC-HRAM- MS/MS). This instrument will be a replacement for a Thermo Velos Pro-Orbitrap Elite with ETD and will enhance the laboratories capabilities for identification and characterization of biotherapeutics, including peptides, proteins, monoclonal antibodies, biosimilars, and oligonucleotides in support of criminal and regulatory investigations involving foods, drugs, dietary supplements, and medical products.

mailto:Yolanda.rankin@fda.hhs.gov

PURPOSE

FCC has provided support to various offices within the Office of Regulatory Affairs, such as the Office of Criminal Investigations, 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 biotherapeutics is a critical capability of the FCC. As such, it is crucial that the FCC has an analytical platform capable of performing the sophisticated analyses required to identify and characterize biotherapeutic samples. A LC-HRAM-MS/MS system is vital for determining the amino acid and nucleotide sequence of peptides/proteins and oligonucleotides, respectively.

Additionally, LC-HRAM-MS/MS provides the ability to decipher higher-order native structures and localization of post-translational modifications in recombinant monoclonal antibodies. The capabilities are indispensable for the analysis of samples containing peptides, proteins, monoclonal antibodies, biosimilars, and/or oligonucleotides. When FCC receives unknown peptides and proteins, the LC-HRAM-MS/MS is the best tool because of the unique ability to use multiple fragmentation methods and provide high resolution-accurate mass data. The multiple fragmentation methods provide a different structural view of the same compound all in one experiment on one instrument. The high resolution and accurate mass provide confidence in assigning chemical formula to observed masses. These two abilities in one instrument have enabled FCC to identify new unknown peptides used as therapeutics in multiple OCI cases and to characterize proteins used as biotherapeutics. A system that meets the performance requirements and salient characteristics described below would enhance our ability to detect, identify, and characterize biotherapeutics, and thereby enhance our ability to protect consumers.

Order Type

FDA intends to award a single firm-fixed-price order for the items described below.

SCOPE

The Forensic Chemistry Center (ORA/ORS/OMPTSLO/FCC) requires the purchase of one (1) liquid chromatography coupled with high resolution-accurate mass tandem mass spectrometer system (LC-HRAM-MS/MS). The system must meet or exceed the following 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 FCC prior to purchase.

1) The mass spectrometer system shall have all new components, and all necessary parts and software to operate with the following specifications:

a) Ionization source salient characteristics

i) The ionization source shall be an atmospheric pressure ionization (API) source that includes the following features:

(1) x, y, and z probe positioning

(2) Heated electrospray ionization (HESI) probe

(3) Interchangeable atmospheric pressure chemical ionization (APCI) functionality

(4) Generation of internal calibrant ions for real-time mass calibration

b) Mass spectrometer ion optics and mass analyzer salient characteristics

i) The instrument shall have ion optics that perform the following functions:

(1) Efficiently focus ions to maximize sensitivity and minimize dissociation

(2) Reduce noise by limiting the number of neutral molecules that enter the mass filters

ii) The instrument shall have a quadrupole mass filter capable of the following:

(1) Precursor ion isolation width < 0.5 Da

(2) Precursor ion isolation range m/z 50-1500 or greater (i.e., precursor ion isolation may go lower than m/z 50 or higher than m/z 1500, but must cover this range at a minimum)

iii) The instrument shall have a multipole ion guide capable of the following:

(1) Efficiently trapping ions and transferring them to the mass analyzers

(2) Performing higher-energy collisional dissociation (HCD) or tandem-in-space MS/MS

(3) Pressure control range of 0.5 to 20 mTorr

iv) The instrument shall have one or more linear ion trap mass analyzers capable of the following:

(1) Scan range m/z 50-1500 or greater (i.e., scan range may go lower than m/z

50 or higher than m/z 1500, but must cover this range at a minimum)

(2) Resonant collision induced dissociation (CID) or tandem-in-time MSn

(3) MSn precursor isolation, CID fragmentation, and product ion spectra acquisition

(4) Electron-transfer dissociation (ETD)

(5) Proton transfer charge reduction (PTCR)

(6) Maximum MSn rate > 40 Hz

(7) Efficient transfer of CID fragment ions for high-resolution mass analysis

v) The instrument shall have a high-resolution mass analyzer capable of the following:

(1) Resolving power of at least 450,000 FWHM at m/z 200

(2) Isotopic fidelity of at least 200,000 FWHM at m/z 200

(3) Mass accuracy < 3 ppm RMS with external calibration or < 1 ppm with internal calibration

(4) Maximum MSn scan rate > 40 Hz

(5) Scan range upper limit m/z of 15,000 or greater

vi) The instrument shall be capable of multiplexing 10 or more precursor ions

vii) The instrument shall be capable of polarity switching

viii) The instrument shall include a syringe pump for tuning and a 6-port valve

(or equivalent) for LC/MS experiments

c) Electrical requirements

i) The mass spectrometer shall be capable of being powered with a single building UPS backed-up 50 amp, 3 phase, 208V direct feed or outlet. (or less)

ii) A power conditioner and/or power distribution unit may be used to provide the needed outlets for the mass spectrometer.

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

a) Binary pump 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 of 50-1500 bar (i.e., pressure may go lower than 50 bar or higher than 1500 bar, but must cover this range at a minimum)

d) Flow rate accuracy of ± 0.1%

e) Flow rate precision of ≤ 0.05% RSD

f) Operable pH range of 2-12

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

h) Column compartment thermostat controlled with temperature range of 20-100ºC

(i.e., temperature range may go lower than 20ºC or higher than 100ºC, but must cover this range at a minimum)

3) Tuning software salient characteristics

a) Instrument control

b) Calibration

c) Compound optimization

d) Diagnostics

e) Manual data acquisition

4) LC/MS software salient characteristics

a) Sequence configuration and automated data acquisition

b) Data processing capable of manual and automated:

i) Bottom-up analysis for the characterization of proteins or upgrade of Proteome Discoverer version 2.1 to the most current software version.

ii) Top-down and middle-down analysis for the characterization of proteins

iii) Intact protein mass analysis

iv) Monoclonal antibody characterization and oligonucleotide sequencing or upgrade of BioPharma Finder version 3.1 to the most current software version.

c) Method editor for configuring methods for small molecule and large molecule identification via various operating modes

5) 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 characterizes

i. Tower configuration

ii. 110 Vac power cord(s)

iii. USB English keyboard

iv. USB optical mouse

v. One (1) or more PCI or PCI Express expansion slots

b. Processor salient characteristics

i. Quad-core, 3.4 GHz or better

c. Memory salient characteristics

i. 16 GB or greater

d. Network salient characteristics

i. Two (2) or more ethernet ports

e. Storage salient characteristics

i. 1 TB or greater SATA hard drive

f. Optical drive salient characteristics

i. SATA 16x DVD ROM

g. Monitor salient characteristics

i. 27” monitor or larger

h. Operating system salient characteristics

i. Windows 10 Professional 64-bit, or newer

II. Trade and Service Specifications

• The system must be a newly manufactured unit, not used and refurbished or previously used for demonstration. The Government must be able to expect routine customer service and technical support to be available from the vendor during its 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.

• FOB destination to include training. An on-site 3-day training class for up to four users will be provided within 60 days of delivery such that operators may independently operate the instrument and increase familiarity and proficiency. The training shall include manuals, hardcopy or electronic, to be used during training.

Shipping Destination

One (1) system to be shipped to the following laboratory:

US Food & Drug Administration Forensic Chemistry Center 6751 Steger Dr.

Cincinnati, OH 45237

Period of Performance

Equipment shall be delivered no later than 90 days after contract award. The Period of Performance begins on the date of formal government acceptance and continues through the end of the manufacturer’s warranty period.

Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before August 14, 2024 by 12:00pm (EST) at the Food and Drug Administration, Attn: Nina Montgomery, email nina.montgomery@fda.hhs.gov. Reference: 75F40124Q121785.

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 pre‐solicitation synopsis and solicitation may be published in 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).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.

mailto:nina.montgomery@fda.hhs.gov.