Statement of Requirement (Final).docx

STATEMENT OF REQUIREMENT

TITLE: ZipChip CE-MS

Requesting Lab/Division/Group: Material Measurement Laboratory (MML)/645/08

I. BACKGROUND INFORMATION

In 2016 the National Institute of Standards and Technology released RM8671 (NISTmAb), a monoclonal antibody reference material generated from a mouse cell line. This reference material represents the largest class of protein therapeutics currently on the market and is one of NIST’s top-selling reference materials. NISTmAb is used across the biomanufacturing industry as a standard for developing new analytical platforms and challenging the limits of new technologies. Prior to its release NISTmAb was throughly characterized using a number of analytical methods. In order to make this reference material longitudinally available, the quality of the material continues to be evaluated at regular intervals so that any changes in the material’s physicochemical properties can be reported to stakeholders. Capillary zone electrophoresis (CZE) has been used to measure charge purity and heterogeneity present in the material for both the original characterization and ongoing lifecycle management. An increase in charge variants observed via CZE can signify an increase in degradative events such as deamidation, lysine glycation, N-terminal glutamination and sialic acid-containing glycan moities. It is not possible, however, to conclusively determine which of these degradative events is the cause of a change in charge variants without the use of a mass spectrometer (MS) coupled to the CZE.

NIST scientists in the biomanufacturing program are also working to produce a follow-on reference material, the cNISTmAb, a monoclonal antibody generated from a Chinese hamster ovary (CHO) cell line. This prospective reference material will be useful for the development of analytical methods relevant to protein therapeutics derived from CHO cells, and in conjunction with the NISTmAb may accelerate development of biosimilar analytical methods. Other biomanufacturing research in progress at NIST necessitated the coupling of MS capabilities to CZE. Ongoing degradation studies using the NISTmAb have generated charge variant species that cannot be effectively resolved and have yet to be confidently identified. The ability to couple a mass spectrometer to CZE instrumentation is necessary for identification of these co-migrating species and to provide a full characterization and understanding of degradative pathways in the NISTmAb.

Current CZE instruments owned by NIST are not capable of filling the analytical needs for ongoing reference material development and upkeep. One instrument is a stand-alone CZE not capable of coupling to any MS detector, the other can only be coupled to previous generations of MS instrumentation which are no longer in use at NIST. The acquisition of a CZE instrument that can be coupled to Thermo Ascend MS instrumentation would directly support the mission of NIST’s biomanufacturing program to make highly relevant, quality reference materials available to the biomanufacturing industry along with reliable measurements of pertinent properties.

II. SPECIFICATIONS

The Contractor shall provide a capillary zone electrophoresis (CZE) instrument which has the capability of coupling to a Thermo Scientific Orbitrap Ascend mass spectrometer (MS) and is available with an autosampler to automatically load multiple samples. A preventive maintenance and service plan to maintain operation of the system is also required. The instrument and service plan shall meet the following minimum specifications:

BASE - Line Item 0001:

Description: Capillary Zone Electrophoresis (CZE) Instrument

Hardware Requirements:

1. ZipChip Ti (compatible with Thermo Scientific Orbitrap Ascend mass spectrometer), auto sampler version with DryDock ZipChip drying accessory (manufacturer part # ZCAS-TI-01)

2. Auto Sampler for ZipChip Interface (96 well-plate or 46-vial format) (manufacturer part # # ZCAS-0-01)

Accessory Requirements:

3. Qualification kit containing peptide reagents, two HS chips, and amino acid standard (for IQ/OQ performance) (manufacturer part # 850-00043)

Software Requirements:

4. Contractor shall provide ZipChip acquisition software and any updates available from the manufacturer during the period of performance.

BASE - Line Item 0002:

Description: Initial Warranty

Initial Warranty/Maintenance Service:

5. Contractor shall provide a one (1) year manufacturer warranty on Hardware Requirement Item #1 and Hardware Requirement Item #2, commencing upon installation and demonstration of the system operation per the service requirements described above. Warranty shall include phone support and remote troubleshooting, ZipChip acquisition software updates, on-site instrument repair (including parts and labor) and preventive maintenance (including parts and labor; one per warranty year). The warranty shall commence upon formal acceptance by the government.

OPTION – Line Item 0003 and 0004 Description: Extended Warranty/Maintenance Service

Option Line Items 0003 through 0004 are for Extended Warranty/Maintenance Services -The Contractor shall provide options to extend the initial one (1) year warranty/maintenance, for up to an additional two (2) years for the Hardware Requirements. Option years to be exercised at the Government’s discretion, in one-year increments.

6. OPTION – Line Item 0003 Description: Option Year 1 of Extended Warranty/Maintenance Services Quantity: 1 Year

7. OPTION – Line Item 0004 Description: Option Year 2 of Extended Warranty/Maintenance Services Quantity: 1 Year

Installation:

8. Contractor shall provide installation and qualification of system, including installation of ZipChip acquisition software and integration of ZipChip acquisition software with MS operating software, within 30 calendar days after delivery.

9. The Contractor shall install the instrument at the Institute for Bioscience and Biotechnology Research (IBBR; 9600 Gudelsky Dr, Rockville, MD, 20850). Installation shall include, at a minimum, uncrating/unpacking of all equipment, set-up and hook-up of all equipment, start-up, demonstration of specifications, and removal of all trash. Qualified personnel shall install the system and perform all activities necessary to ensure the system is fully functional and meets all required specifications identified in the Statement of Requirement.

10. Installation must take place during normal business hours, between 8:30 am and 5:00 pm Eastern Time, Monday through Friday except Federal Holidays, and must be coordinated with the NIST Subject Matter Expert (SME).

Training:

11. Contractor shall provide on-site training (manufacturer part # ZC-TRN-1DUS) at the Institute for Bioscience and Biotechnology Research (IBBR; 9600 Gudelsky Dr, Rockville, MD, 20850) for NIST/IBBR personnel covering normal operation, troubleshooting, and routine maintenance. Training will be provided during normal business hours, between 8:30 am and 5:00 pm Eastern Time, Monday through Friday, except Federal Holidays, and will be coordinated with the NIST SME to ensure maximum availability of NIST personnel. Training shall be provided within 30 calendar days of instrument installation and may be done immediately following installation and demonstration of qualification.

III. PERIOD OF PERFORMANCE

The period of performance for the initial warranty shall begin upon formal acceptance of the instrument, by the Government. Additional option years of extended warranty will run consecutively as follows:

Initial Warranty: FY25-FY26 Extended Warranty Option Year 1: FY26-FY27 Extended Warranty Option Year 2: FY27-FY28

Exact dates will be identified at the time of award.

IV. PLACE OF PERFORMANCE

Contractor shall deliver hardware components, install hardware and software, and provide training and service at the Institute for Bioscience and Biotechnology Research, 9600 Gudelsky Dr, Rockville, MD, 20850 during normal business hours (between 8:30 am and 5:00 pm Eastern Time, Monday through Friday except Federal Holidays). and/or phone 240-314-6105.

V. DELIVERABLES

Within the performance period the Contractor shall provide the following deliverables:

VI. ACCEPTANCE CRITERIA

Formal Government acceptance of the system will be given at the time the Contractor demonstrates that all performance specifications in this statement of requirement have been met.

VII. GENERAL INFORMATION

Safety: The Contractor employee shall be responsible for knowing and complying with NIST installation safety prevention regulations. Such regulations include, but are not limited to, general safety, fire prevention, and waste disposal.

Security: NIST is a restricted campus. An identification badge is required for access for entry into buildings and also is shown to the armed Security Police when entering the campus.

Identification Badges: Contractor employees shall comply with NIST identification and access requirements. Each Contractor employee shall wear a visible identification badge provided by the NIST Security Office.

Vehicle Registration: All Contractor employees must register their vehicles with the NIST