FDA-SOL-FY21-1238672.pdf

FDA-SOL-FY21-1238672

Cyclic ION Mobility Spectrometry (IMS) and Time of Flight (TOF) Mass Spectrometers with Delivery, Installation and Onsite Training

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.6 as supplemented with FAR Part 13 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-05 dated March 10, 2021.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE

SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is FDA- SOL-FY21-1238672 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation is 334516 – Analytical Laboratory Instrument Manufacturing. This will be awarded as Firm-Fixed Price. The Government reserves the right to award an order without discussions if the Contracting Officer determines that the initial offer is providing the Best Value and discussions are not necessary.

The Government intends to issue a Purchase Order.

The U. S. Food and Drug Administration (FDA) has a need to procure an DM#51-24 Cyclic ION Mobility Spectrometry (IMS) and Time of Flight (TOF) Mass Spectrometers with Delivery, Installation and Onsite Training.

Statement of Work (SOW)

DM#51-24 Cyclic ION Mobility Spectrometry (IMS) and Time of Flight (TOF) Mass

Spectrometers with Delivery, Installation and Onsite Training

1. Scope of Work

The scope of this SOW is to purchase two new high-resolution mass spectrometers (HRMS) coupled with high performance liquid chromatography (HPLC) systems: the cyclic Ion Mobility spectrometry (IMS) and the Time-of-flight (ToF) HRMS.

2. Statement of Need

Background: High resolution mass spectrometer (HRMS) is becoming critical in the characterization of complex and biological drugs including peptides, proteins, polysaccharides, oligonucleotide therapeutics, and other complex mixtures. The accurate mass (MS) needs to be obtained to confidently identify active ingredients, isoforms, and impurities. The high resolution

(HR) is needed to differentiate all the components in these highly complex and heterogeneous systems. High sensitivity is also essential for detection of low abundance species including modifications and impurities. The HRMS needs high scan acquisition rate to acquire sufficient information to perform comprehensive analysis on complex systems. Additionally, advanced separation techniques such as Cyclic ion mobility spectrometry (IMS) allows improved separation of ions per shape and size, needed in the analysis of complex biologics. Physical separation of highly heterogeneous complex drug products is needed prior to MS analysis and is achieved with high performance liquid chromatography (HPLC). HPLC is an advanced separation methodology and would be used for robust separation of large molecules prior to analyses. The LC-MS system permits the analysis of multiple critical quality attributes on a single analytical platform, enables complete process and product characterization and offers the potential for drug manufacturers to gain deep understanding of their manufacturing processes, particularly in the complex biopharmaceutical manufacturing.

3. Requirements

• Technical Requirements for Cyclic Ion Mobility Spectrometer (IMS) o Instrument shall consist of a high-resolution mass spectrometer with adjustable high-resolution ion mobility separations.

o The user shall be able to easily select either a single or double pass geometries via the data system to provide spectral resolution >100,000 in Full Width at Half Maximum (FWHM).

o Maintain high scan rates of up to 50 Hz while maintaining spectra resolution

>100,000 FWHM.

o The low end of the Mass range of the analyzer must be < 30 m/z.

o The high end of the Mass range of the analyzer must be > 60,000 m/z.

o The linearity of the MS analyzer shall cover over 5 orders of magnitude.

o The Cyclic IMS device shall incorporate an ion mobility separation cell with a multifunctional ion entry/exit array and a pre array store which will enable single pass acquisitions (a resolution of over 60) and Multiple pass acquisitions (a resolution of over 400).

o The Cyclic IMS device shall enable IMSn activation and fragmentation with n≥3.

o The Cyclic IMS device shall incorporate a Trap cell which acts as a collision cell to fragment ions.

o The instrument shall enable fragmentation of both pre- and post- ion mobility separation.

o The instrument shall enable m/z selection on pre-ion mobility separation with a high-performance quadrupole analyzer.

o Instrument shall have multiple dissociation capabilities of Collision Induced

Dissociation (CID), Surface Induce Dissociation (SID) and Electron Capture Dissociation (ECD).

• Technical Requirements for Time-of-flight (ToF) High Resolution Mass Spectrometer (HRMS) o Instrument shall consist of a high-resolution time-of-flight analyzer.

o The MS shall include dual off-axis ion guides for elimination of neutral noise with increased sensitivity and robustness.

o The system shall automatically provide the users with targeted guidance to resolve specific issues from within the software, removing the need for a user to search for solutions to the issues.

o The MS display shall provide a visual indication when specific areas of the instrument require troubleshooting or attention.

o The system shall provide a full application workflow, including dedicated informatic features for the following analyses: Intact Mass Analysis, Peptide Mapping Analysis, Oligonucleotide Analysis, and Multiple Attribute Monitoring.

o Features automated tuning and calibration with premade commercial standards, which not only improve instrument throughput, data/result consistency, but makes the system easier to use for all scientists.

o The system shall provide reference libraries for released glycans, considering different labelling chemistries, which includes accurate mass and glucose units (GU) information.

o The MS shall be benchtop in design, having a footprint no bigger than a size of 80

(H) x 60 (W) x 80 (D) cm (H x W x D).

o The MS shall include a pre-optimized ionization source which requires no physical user-adjustment for consistent performance.

o The MS shall be able to automatically perform a system set-up incorporating beam check, detector set-up, analyzer tuning, calibration and lockmass setup, following a single click by the analyst within the software.

o All supported mass ranges and polarity modes must be set-up and calibrated using the same pre-defined solutions installed on the MS fluidics.

o The MS shall only require a single gas supply (Nitrogen) connected through a single inlet to the MS

• Requirements for HPLC System of Cyclic IMS o HPLC System shall have full integration into Cyclic IMS Software for finite control to ensure precise timing of chromatography for IMSn experiments.

o Total system band spread of less than 12uL.

o Total Dwell Volume of less than 400ul.

o Settable flow rate range of 0.001 to 2.200 mL/min.

o Maximum Operating Pressure of 15,000 psi.

o pH range of 1 to 12.5.

o Blend up to four solvents in any combination with an option to expand to six solvent selection valves.

o Automated, on-line pH, ionic strength, and organic modifier blending from pure solvents.

o Pressure pulsation of less than 1% or 25psi, whichever is greater.

o Flow accuracy of +/- 1% at 0.5 to 2.0 mL/min.

o Flow precision of <0.075% in relative standard deviation (RSD).

o Automatic and continuous compressibility compensation.

o Biocompatible with primary wetted materials being only: Titanium, PPS, Fluoropolymer, MP35N, gold plated stainless steel, Vespel SCP, fluoroelastomer, UHMWPE blend, sapphire, ruby, zirconia, nitronic 60, DLC, PEEK and PEEK blend o Injection volume range 0.1 to 10.0 uL with optional up to 1,000 uL loop.

• Requirements for HPLC System of ToF-HRMS o HPLC System shall have full integration into ToF-HRMS Software.

o The total system dwell volume must be ≤ 100 μL.

o Total system band spread must be ≤ 9 uL.

o The pump shall be a binary pump designed for ultra-performance liquid chromatography, designed to blend 2 (two) solvents and to select between four solvents.

o The pump shall have an integrated degasser with an independent channel for each solvent. The degasser must support additional channels for the sample manager.

The total solvent volume must be ≤ 480 µL.

o The pump flow shall be settable from 0.001 - 2,000 μL/min, in 1 μL/min increments. The pump flow accuracy shall be ≤ ± 1.0% at 0.5 to 2.0 mL/min using 100% Solvent A, and the pump flow precision must be ≤ 0.075% RSD or 0.01min SD, whichever is greater.

o The maximum operating pressure of the pump shall be at least 18,000 PSI (pounds per square inch) or 1,200 bar.

o The pump contribution to delay volume shall be <7 µL including the filter and <60 µL with the default mixer configured.

o The sample manager precision shall be ≤ 0.25% RSD for the 5.0 to 50.0 μL range.

o The sample manager carryover shall be less than 0.001% from sample to sample, with Caffeine (UV) and ≤ 0.001% with Sulfadimethoxine (MS).

o The sample manager shall use a degassed solvent for aspiration of the sample.

• Requirements for services o The vendor shall perform and document IQ/OQ including installation and testing.

o The vendor shall provide software /hardware familiarization and training course at place of performance.

o DA will be able to reasonably expect service and technical support from the vendor during its lifecycle.

o Standard warranty shall apply, including at least 1-year period on parts, travel, and labor from the date of IQ/OQ completion.

If trade-in offer is accepted, the vendor shall be responsible for all packaging, handling, and shipping of the trade-in system.

OPTIONS

• Trade-in option with purchasing of new instrument o Mass spectrometer for trade-in option: Synapt G2Si W/ MALDI Source, Serial number: UGA255.

o Purchased date: delivered on 11/15/2013.

o Number of years in use: 7 years.

o Equipment is in good condition and is currently covered by a service contract.

o Last date of servicing: 6/19/2020.

o Repair issues: Technical issue, Low resolution of the Ion Mobility o Samples last run on the instrument: samples still currently run on the instrument with a frequency of ~ 80 hrs per month o Available pick-up date: The instrument pickup cannot be arranged until the contract is awarded. The instrument cannot be picked up until closer to the installation of the new instrument but no later than 2-3 weeks before the scheduled installation to leave sufficient time for getting the space ready for the new instrument.

o Photo of the instrument:

4. Delivery

US Food and Drug Administration (FDA) located in 645 S Newstead Ave., St. Louis, MO 63110 receives the deliverables.

Deliverable Description Quantity/

Media Date Completed

Cyclic Ion Mobility Spectrometer (IMS) mass spectrometer coupled with HPLC, meeting technical requirements.

Within 120 days of award

Time of Flight (ToF) High resolution (HR) MS

System coupled with HPLC, meeting the requirements.

Within 120 days of award

3 Install and instrument qualification 1

Within 90 months of the system delivery

4 User training course 1

Within 60 days of the system installation and qualification

Options

5 Trade-in removal if trade-in offer is to be accepted 1

21 days before installation of new system

5. Period of Performance

The period of performance is 270 days from the contract award date. One-year manufacture warranty. Additional service agreement may apply after the completion of warranty period.

6. Place of Performance

Food and Drug Administration

645 S Newstead Ave.

St. Louis, MO 63110

7. Reporting Requirements and Deliverables

The contractor shall provide 30-day notice prior to shipping. All reports for installation and qualification shall be provided (electronic format preferred). Acceptance will be made by the government within 30 days following completion of instrument installation and qualification

8. Acceptance Criteria

Partial acceptance is made upon delivery of all the parts. Full acceptance is made after completion of Installation and Operational Qualification (IQ/OQ) by the contractor that the system meets all the specifications and requirements.

9. Special Requirements

Security: Supervision of install engineer upon arrival at OTR St. Louis will be required. All software required must be approved on FDA’s Master Approved Technology (MAT) list and comply with OIMT requirements. Software not already on the FDA MAT list may be considered but must be approved on MAT list prior to award.

Other Unique Requirements: If contract is awarded for a non-benchtop mass spectrometer, additional requirements will be required to ensure sufficient floor space is available to ensure proper housing and operation. Further considerations for the installation of magnetic shielding may need to be considered if these are required. These considerations should be evaluated on an instrument-by-instrument basis.

IT PURCHASING REQUIREMENTS:

NOTE to Contractor: Before the task order is awarded, FDA is required to get pre-approval of all the IT hardware and/or software-firmware-freeware from the FDA Chief Information

Officer (CIO). For IT hardware, this includes any device that processes or stores data, or is controlled by data (computers/data switches, etc.), but does not include passive hardware

(rack, network cables, power supplies/cords, etc.). This will require the applicable Vendor to provide a complete list of hardware and/or software-firmware-freeware that the

Vendor will use in fulfilling this task order.

This list will need to include:

1. IT hardware: manufacture, nomenclature and model number

2. Software (all types): manufacture, nomenclature and version number

Item(s) rejected by the CIO will need to be changed and the replacement item(s) would need to go through the same approval process.

10. Technical Evaluation Criteria:

Bids should explain why and how their instrument (LC-MS) meets or exceeds each detailed technical requirement and include supportive data and description wherever possible.

o Technical specifications: Award will be related to the degree to which the vendor meets or exceeds the detailed technical specifications of the instrument (LC-MS).

o Service capability: Award will be related to the ability of the vendor to provide technical support and service for the instrument (LC-MS). This factor can be met by demonstrating that the vendor’s service department has been adequately staffed in previous years or by customer endorsements or by other methods.

o Suitable for intended purpose: Award will be related to the ability of the vendor to demonstrate that their instrument has been used successfully by the pharmaceutical industry for applications with similar technical demands.

o Trade-in consideration: A trade-in offer for Waters Synapt G2Si W/ MALDI Source will be considered but not required for the award.

11. Instructions to the Offer

SAM: All interested offerors shall be registered in the System for Award Management (SAM), if the offeror is not registered in SAM, please visit https://www.sam.gov. You will need your Tax ID, DUNS Number and banking information.

Vendors who are not registered in SAM will not be eligible for award. The Government reserves the right not to negotiate and award without discussion.

QUESTIONS are to be submitted via email to Linda.Troutman@fda.hhs.gov no later than April 26, 2021 at 10:00 a.m., ET. They will be addressed via an update to the solicitation by COB on May 3, 2021.

QUOTATIONS shall be submitted via email to Linda.Troutman@fda.hhs.gov by May 17 , 2021 at 10:00 a.m., ET. Please provide the Solicitation Number FDA-SOL-FY21-1238672 in the subject line of the email http://www.sam.gov/ mailto:Linda.Troutman@fda.hhs.gov mailto:Linda.Troutman@fda.hhs.gov

PROVISIONS and CLAUSES:

The Full text of the Federal Acquisition Regulation (FAR) can be accessed on the internet at https://www.acquisition.gov/far/

The following provisions and clauses apply: FAR 52.212-1, Instructions to Offerors Commercial Items; FAR 52.212-2, Evaluation-Commercial Items; FAR 52.212-3 Offeror Representations and Certifications-Commercial Items; FAR 52.212-4, Contract Terms and Conditions Commercial Item; FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes Or Executive Orders--Commercial Items; 52.211-6 Brand Name or Equal; FAR 52.219-6, Notice of Total Small Business Set-Aside; FAR 52.219-8, Utilization of Small Business Concerns; FAR 52.219-13 Notice of Set-Aside of Orders; FAR 52.222-3, Convict Labor; FAR 52.222-19, Child Labor--Cooperation with Authorities and Remedies; FAR 52.222-21, Prohibition of Segregated Facilities; FAR 52.222-26, Equal Opportunity; FAR 52.222-36, Affirmative Action for Workers with Disabilities; FAR 52.232-18 Availability of Funds; FAR 52.232-33 Payment by Electronic Funds Transfer—System for Award Management; FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors. Parties responding to this solicitation may submit their offer in accordance with their standard commercial practices (e.g. on company letterhead, formal quote form, etc.) but shall include the following information: 1) company’s complete mailing and remittance addresses 2) discounts for prompt payment if applicable; 3) Dun & Bradstreet number; 4) Taxpayer ID number; 5) Catalog or Published Price Listing applicable to the service; 6) Offerors shall meet specifications as noted in the synopsis. Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications/Commercial Items with their offer. Note: Contractor shall be registered and active in the System for Award Management (SAM) prior to the award of a contract. You may register by going to www.beta.sam.gov.

https://www.acquisition.gov/far/ http://www.beta.sam.gov/