Combined_Syn.docx

ALP: CDER-2026-131687

Mass Spectrometer

COMBINED SYNOPSIS/SOLICITATION

1. INTRODUCTION

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation. Offers are being requested and a separate written solicitation will not be issued.

Solicitation number 75F40126Q00088 is issued as a/an [☒ RFQ ☐ RFP ☐ IFB] for one Thermo Scientific Orbitrap Excedion Pro BioPharma MS and UHPLC system to enhance CDER/OPQ/OPQR – St. Louis' capability in characterizing drug substances and drug products with potential nitrosamine impurities, small molecules, and macro biomolecules in support of domestic drug manufacturing. The Orbitrap Excedion Pro represents the next generation of Orbitrap technology, providing enhanced performance for both small molecule and biotherapeutic applications while maintaining cost-effectiveness for comprehensive analytical requirements.

This acquisition [☒ is / ☐ is not] set-aside for small business concerns. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at: https://acquisition.gov/ | https://acquisition.gov/far-overhaul | https://acquisition.gov/hhsar

All responsible sources may submit a [☒ quotation ☐ bid ☐ proposal], which will be considered by the agency.

NAICS Code: 334516 Small Business Size Standard: Small Business 1,000 Employees Set-Aside: ☐ None ☒ Total Small Business ☐ WOSB ☐ SDVOSB ☐ 8(a) ☐ HUBZone ☐ Other: [specify]

2. DESCRIPTION OF REQUIREMENTS

The Government intends to acquire a high-resolution mass spectrometry system with ultra-high-performance liquid chromatography capability to support the analysis of pharmaceutical drug substances and drug products, including detection and characterization of nitrosamine impurities, small molecules, peptides, and other biomolecules. The Thermo Scientific Orbitrap Excedion Pro BioPharma MS and UHPLC system is referenced as the brand-name product used to define the level of performance and functionality required.

This acquisition is conducted on a brand-name-or-equal basis. Products offered as an “equal” must meet or exceed the salient characteristics identified below in order to be considered technically acceptable.

The Government requires an integrated LC-MS analytical system capable of supporting regulatory-grade analytical workflows for pharmaceutical quality evaluation and impurity characterization. The system must provide high-resolution, accurate-mass detection across a wide mass range to support both small molecule and biomolecule applications, including trace-level impurity detection and characterization of peptide-based therapeutics.

At a minimum, the offered system shall meet the following salient characteristics:

• High-resolution accurate-mass (HRAM) mass spectrometry system capable of resolving complex mixtures and trace-level impurities in pharmaceutical samples

• Mass analyzer capable of achieving resolving power sufficient for high-confidence molecular identification and impurity characterization

• Extended mass range capability to analyze both small molecules and larger biomolecules (minimum mass range approximately up to m/z 12,000)

• Sensitivity sufficient for trace-level detection of pharmaceutical impurities, including nitrosamines

• Compatibility with an integrated ultra-high-performance liquid chromatography (UHPLC) system suitable for biocompatible analytical applications

• Integrated instrument control and data analysis software capable of supporting advanced analytical workflows for small molecule and peptide characterization

• Capability for automated data processing, spectral deconvolution, and identification workflows for complex pharmaceutical samples

• Centralized data management capability supporting secure instrument operation, workflow automation, and laboratory data integration

• Delivery, installation, and instrument qualification (IQ/OQ) services for the complete LC-MS system

• Vendor-provided instrument familiarization and operational training

• Minimum one (1) year manufacturer warranty covering parts, labor, travel, and OEM-certified service support, beginning upon Government acceptance of the system The Government will evaluate quotations offering the referenced brand-name product or equal products that meet the above salient characteristics. Offerors proposing an equal product must clearly demonstrate in their quotation how the proposed equipment meets or exceeds each of the required salient characteristics.

3. LINE ITEMS

4. DELIVERY AND PERFORMANCE

Place of Delivery / Place of Performance: CDER/OPQ/OPQR – St. Louis, 645 S. Newstead Ave., Saint Louis, MO 63110 FOB Point: [☒ Destination Inspection and acceptance shall be performed by the COR/Program Office within 5 business days after delivery, installation, IQ/OQ, Ardia Platform setup, BioPharma Finder installation, and training are completed.

Inspection and acceptance shall be performed at the delivery location in accordance with clause 52.212-4.

Period of Performance Supplies: Delivery Timeframe + Warranty + Option Periods for Preventative Maintenance:

Delivery shall be completed within [XX weeks / months] of award. The delivered items shall include a [one (1)] year warranty. The warranty period begins on the date of Government acceptance under the inspection and acceptance clause(s) of this contract.

The base period covers delivery, installation, training (if applicable), and the warranty period. Option periods for preventative maintenance begin the day after the warranty period ends, with no gap between periods.

Following Government acceptance, the Contracting Officer will issue an administrative modification under RFO 43.203(b)(1) and 43.201 to memorialize the period of performance dates, anchored to the Government acceptance date. The modification does not change scope, price, or any other substantive term. The Contractor's written confirmation of the installation completion date supports inspection and acceptance scheduling; it does not establish the period of performance.

Base Period: [CONTRACT AWARD DATE] through [WARRANTY END DATE] Option Period 1: [DAY 1 AFTER WARRANTY END DATE] through [12 MONTHS] Option Period 2: [DAY 1 AFTER OP1 END DATE] through [12 MONTHS] Option Period 3: [DAY 1 AFTER OP2 END DATE] through [12 MONTHS] Option Period 4: [DAY 1 AFTER OP3 END DATE] through [12 MONTHS]

5. CONTRACT CLAUSES

5A. Clauses Incorporated by Reference

5B. Clauses Incorporated by Full Text

52.252-2, Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://acquisition.gov https://acquisition.gov/far-overhaul https://acquisition.gov/hhsar (End of clause)

FDA Electronic Invoicing and Payment Requirements — Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov

c. 1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(1) list of all invoices submitted to date under the subject award, including the following:

(i.) invoice number, amount, & date submitted (ii.) corresponding payment amount & date received

(2) total amount of all payments received to date under the subject contract or order .

e. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

f. If the supplies or deliverables are rejected for failure to conform to the technical requirements of the Delivery Order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

g. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

h. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

i. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

(End of clause)

6. SOLICITATION PROVISIONS

6A. Provisions Incorporated by Reference

Basis for Award Lowest Price Technically Acceptable (LPTA): Award will be made to the lowest-priced offeror whose offer is determined technically acceptable. Technical acceptability will be determined on a pass/fail basis against the salient characteristics and minimum requirements of the requirement. Offers that do not meet all salient characteristics will be determined technically unacceptable and will not be considered for award. Price will be evaluated for reasonableness.

6B. Addenda to 52.212-1 Offer Acceptance Period (if applicable):

Paragraph (b) of the provision is hereby amended to extend the period for acceptance of offers from 60 calendar days to 90 calendar days from the date specified for receipt of offers.

7. OFFER SUBMISSION AND POINTS OF CONTACT

Questions Due: Questions regarding this solicitation shall be submitted in writing to the Primary POC identified in the SAM.gov notice: May 6, 2026 12:00pm. Questions and answers may be posted as an amendment to this solicitation on SAM.gov.

Offers Due: As listed on the SAM.gov notice.

Submission Method: Email to the POCs listed in the SAM.gov posting.

Preferred File Format: Searchable PDF and Excel Page Limit (if applicable): N/A

Offerors Shall Submit:

1. Technical quotation. Offerors proposing equal products shall submit a salient characteristics compliance matrix identifying each characteristic from Section 2, the proposed specification for that characteristic, and supporting manufacturer documentation. Quotations from equal-product offerors that do not include this matrix will be deemed technically unacceptable.

2. Price quotation

3. Warranty terms (if applicable)

4. UEI and confirmation of active SAM.gov registration

5. Lead time for delivery

6. Country of origin for all items

Points of Contact As listed on the SAM.gov notice.

8. ADDITIONAL INFORMATION

One or more of the items under this acquisition is subject to the World Trade Organization Government Procurement Agreement and Free Trade Agreements

Amendments:

Any amendments to this solicitation will be posted to SAM.gov. It is the offeror's responsibility to monitor SAM.gov for any amendments.

Attachments (if applicable):

Statement of Work Thermo Scientific Orbitrap Excedion Pro MS and UHPLC System with BioPharma Finder Data Analysis Software and Ardia Platform for Software and Instrument Management Background The Office of Pharmaceutical Quality Research – St. Louis (OPQR – St. Louis) has been providing laboratory testing and research support and has been working with the Office of Pharmaceutical Quality (OPQ) Nitrosamine Taskforce since the beginning of the nitrosamine contamination issue which started in early 2018. Seven years later and the nitrosamine issue has not gone away but has gotten bigger in scope. The problem started with small nitrosamine contamination (i.e. NDMA, NDEA, etc.) in angiotensin receptor blocker (ARB) drug products. However, the contamination issue over the years has grown to include nitroso drug substance related impurities (NDSRIs) and fragment NDSRIs in both prescription and over the counter (OTC) drug products.

OPQR – St. Louis requires a new Orbitrap Excedion Pro MS system to support advanced testing and research on nitrosamine impurities, small molecules, and macro biomolecules in drug products and substances. The Orbitrap Excedion Pro MS system provides enhanced capabilities beyond the existing Exploris platforms, including:

Extended mass range up to m/z 12,000 for large biomolecule analysis Fast and sensitive electron-based fragmentation (ETD/EThcD) for comprehensive structural characterization Enhanced sensitivity and dynamic range with eDR scan mode Superior fragmentation capabilities for complex molecule identification The excellent sensitivity, resolution, and advanced fragmentation capabilities of this mass spectrometer will be used to identify nitrosamine drug substance related impurities (NDSRIs) by matching accurate mass measurements with calculated monoisotopic masses, and to develop fit-for-purpose methods to accurately detect and quantitate NDSRIs. Additionally, the system will support comprehensive biotherapeutic characterization, including peptide mapping, intact mass analysis, and post-translational modification studies.

This work requires a high-resolution, accurate mass spectrometer with advanced fragmentation capabilities like the Orbitrap Excedion Pro. The system will integrate with the Ardia Platform for centralized data management and utilize BioPharma Finder software for comprehensive data analysis workflows.

Objective To purchase one Thermo Scientific Orbitrap Excedion Pro BioPharma MS and UHPLC system to enhance CDER/OPQ/OPQR – St. Louis' capability in characterizing drug substances and drug products with potential nitrosamine impurities, small molecules, and macro biomolecules in support of domestic drug manufacturing. The Orbitrap Excedion Pro represents the next generation of Orbitrap technology, providing enhanced performance for both small molecule and biotherapeutic applications while maintaining cost-effectiveness for comprehensive analytical requirements. This acquisition will be awarded as a Firm-Fixed-Price (FFP) contract in accordance with FAR Part 12 and FAR Part 13 procedures for the procurement of commercial products and services.

Scope The Thermo Scientific Orbitrap Excedion Pro BioPharma MS and UHPLC system is cited as the brand-name or equal reference. This designation is used to describe the salient performance characteristics required. Products of equal capability meeting all salient characteristics identified in this SOW will be considered.

This statement of work covers the delivery, installation, qualification, and instrument familiarization on one new Orbitrap Excedion Pro BioPharma MS and UHPLC system. Upon installation, operation of the instrument and performance qualification shall be demonstrated.

The specifications listed in this SOW represent the minimum salient characteristics required for the Government's intended use. Offerors proposing an equal product must clearly demonstrate how their system meets or exceeds these characteristics.

Detailed Technical Requirements The proposed acquisition package shall include:

· High resolution and accurate mass (HRMS) spectrometer with extended mass range capabilities up to at least 12,000 m/z

· Ultra-high performance liquid chromatograph (UHPLC) compatible with biocompatible applications

· IQ/OQ of the LC-MS system

· Computer with preloaded instrument control software

· Ardia Platform connectivity for centralized data and instrument management

· BioPharma Finder 5.3 software for comprehensive data analysis

· Vendor provided instrument and software familiarization Specifications The proposed specifications of UHPLC-MS systems shall include:

Tasks Performed by Vendor Installation & Qualification : The vendor shall perform and document IQ/OQ, ensuring system meets all specifications Training: Provide software/hardware familiarization for 2-3 scientists at OPQR – St. Louis Technical Support : Provide free unlimited technical support for the life of the instrument (phone and internet) Warranty : Standard warranty of at least 1 year for parts, travel, and labor from IQ/OQ completion Service Options : Provide service agreement option for annual preventative maintenance following warranty Ardia Platform Setup : Configure and validate Ardia Platform connectivity for data management BioPharma Finder Installation : Install and configure BioPharma Finder software with method templates Trade and Service Specifications Newly manufactured unit (not used, refurbished, or demonstration) Service and technical support capability throughout instrument lifecycle Parts and labor warranty for 12 months from installation Extended warranty/service contract capability (optional) Deliverables and Timeline Contract period: 12 months from award Optional service agreement: 1 year annual preventive maintenance following warranty Delivery : Within 90 days after award Installation & Qualification : Within 90 days of delivery Training & Familiarization : During qualification or within 60 days after installation Warranty Start : At time of IQ/OQ completion Delivery Location CDER/OPQ/OPQR – St. Louis 645 S. Newstead Ave.

Saint Louis, MO 63110

Reporting Requirements and Deliverables 30-day notice prior to shipping All installation and qualification reports (electronic format preferred) Ardia Platform configuration documentation BioPharma Finder method validation reports Government acceptance within 30 days following completion of installation and qualification Acceptance Criteria Partial Acceptance : Upon delivery of all system components Full Acceptance : After completion of IQ/OQ demonstrating system meets all specifications, successful Ardia Platform integration, BioPharma Finder software validation, and completion of familiarization training Acceptance will be performed by the OPQR – St. Louis designated Government technical representative in coordination with the Contracting Officer.

Special Requirements Supervision of installation engineer(s) required upon arrival at OPQR – St. Louis All software must be approved on FDA's Master Approved Technology (MAT) list and comply with OIMT requirements Xcalibur software (already on MAT list) Chromeleon CDS (already on MAT list) BioPharma Finder software (already on MAT list) Ardia Platform (verification of MAT status required)

System Components Summary

Final Deliverables

User familiarization and BioPharma Finder training

During qualification or 60 days after installation

FDA OAGS — Supplies | Page 1