Statement of Requirement (Final).pdf

STATEMENT OF REQUIREMENTS

TITLE: Ultra-high Performance Liquid Chromatography (UHPLC) Systems for Protein

Analysis

I. BACKGROUND INFORMATION

The Biomolecular Structure and Function (BSF) group in the Biomolecular Measurement

Division of the Materials Measurement Laboratory at the national Institute of Standards and

Technology (NIST) (1) advances novel measurement methods and models for the determination and analysis of the structure and function of biological macromolecules, including lipids, DNA, RNA, and proteins and macromolecular complexes and assemblies formed by these molecules; (2) advances methods to determine the physical and chemical factors which determine the specific interactions of macromolecules with cofactors and ligands; (3) studies the relationships between biomolecule structure, dynamics, function, and energetics using computational, biophysical and biochemical techniques; (4) develops reference databases for these properties; and (5) advances measurement methods for engineering complex biological systems.

In support of this mission, the BSF group is establishing a biomanufacturing testbed for representative processes used during the production of therapeutic proteins. To support this work, the group requires capabilities to perform offline characterization of protein properties by ultra-high performance size exclusion chromatography and of protein concentration by ultra-high performance affinity chromatography. It is anticipated that two ultra-high performance liquid chromatography (UHPLC) systems will meet this need.

II. SPECIFICATIONS

The Contractor shall deliver, install and provide training for two (2) UHPLC instruments having specifications described below.

Hardware Requirements for UHPLC System 1 and UHPLC System 2:

• The UHPLC systems shall be new instruments and not refurbished.

• The UHPLC systems shall consist of a multisampler, UHPLC pump with degassing capabilities, column oven, variable wavelength UV detector (VWD), and fraction collector.

• The UHPLC systems must have a self-contained modular UHPLC form factor with solvent resistant material used in all areas that may have contact with mobile phase.

• The UHPLC systems must have internal fluid paths compatible with mobile phases having pH greater than or equal to pH 2.0 and less than or equal to pH 12.0.

• The UHPLC systems must have max operating pressure of at least 100 MPa (1000 bar) at up to 5 mL/min flow rate and a max operation pressure of at least 80 MPa (800 bar) at greater than 5 ml/min flow rate.

• The UHPLC systems must have pumps with settable flow range of at least 0.001 to 8 mL/min, in 1 μL/min increments.

• The UHPLC systems pumps must deliver flow rate of up to 5mL/min in high pressure binary mixing operation.

• The UHPLC systems pumps must have a flow accuracy of at least ± 0.1%

• The UHPLC systems pumps must have flow precision of at least ≤0.05% RSD or ≤0.01 min

SD, whichever is greater.

• The UHPLC systems pumps must have gradient proportioning accuracy of at least ± 0.2% of full scale.

• The UHPLC systems pumps must have gradient proportioning precision of at least ≤ 0.15%

SD

• The UHPLC systems pumps must have use a dual-pistons in series system.

• The UHPLC systems pumps must have integrated 2-channel degassing units.

• The UHPLC systems multisamplers must have cooling capabilities down to at least 4 °C.

• The UHPLC systems mulitsamplers must be equipped with at minimum two injection plates capable of holding 54 or more standard HPLC vials each.

• The UHPLC systems multisamplers must have outer needle wash for carryover reduction.

• The UHPLC systems multisamplers must have carryover specification of at least ≤ 0.002%

• The UHPLC systems multisamplers must have injection volume range of at least 0.01 to

25µL in 0.1 µL increments.

• The UHPLC systems multisamplers must have injection volume precision of at least ≤ 0.25% area RSD for 1 μL injection.

• The UHPLC systems column compartments must accommodate columns of up to 30 cm in length.

• The UHPLC systems column compartments must be capable of heating and cooling in the range of at least 18 °C below ambient to 120 °C (absolute) controllable in 0.1 °C increments.

• The UHPLC systems column compartments temperature accuracy must be at least ± 0.5°C

(up to 80°C)

• The UHPLC systems column compartments temperature stability must be at least ± 0.05°C.

• The UHPLC systems column compartments must have integrated two-position, six-port valve compatible with the same pressure range as of the pump.

• The UHPLC VWD detectors must be capable of at least single-wavelength detection at an acquisition rate of at least 250 Hz and dual-wavelength detection at an acquisition rate of at least 5 Hz.

• The UHPLC VWD detectors must have a wavelength range of at least 190 to 900 nm.

• The UHPLC VWD detectors must have linearity of at least ≤ 5% at 2.5 absorbance units

(AU).

• The UHPLC VWD detectors noise, as measured by ASTM method, must be at least ± 2.5 μAU at 254 nm.

• The UHPLC VWD detectors signal drift must be at least ≤ 0.1 mAU/h at 254 nm.

• The UHPLC VWD detectors must have wavelength accuracy of at least ± 1 nm, and wavelength precision of ≤ ± 0.1 nm.

• The UHPLC VWD detectors must be compatible with flow cells that are either end-user exchangeable or exchangeable by field installation and are available with maximum volumes ranging from, at minimum, 2.5 µL to 11 µL.

• The UHPLC VWD detectors must be provided with a flow cell having a maximum volume of 11 µL.

• The UHPLC fraction collectors must be able to be fully integrated in the system stack.

• The UHPLC fraction collectors must be suitable for flow rates in the range of at minimum

0.05 to 10.0 mL/minute.

• The UHPLC fraction collectors must be temperature controlled in the range of at minimum 4

°C to 40 °C.

• Contractor shall provide one (1) copy of manuals for operations and user-maintenance of the

UHPLC systems in either hard-copy or electronic format.

Additional Hardware requirements for UHPLC System 2

• UHPLC System 2 must meet all specifications described above.

• UHPLC System 2 must include a fluorescence detector compatible with either stainless steel or biocompatible flow cells.

• UHPLC System 2 fluorescence detector must be able to acquire spectra (excitation or emission) during the analysis

• UHPLC System 2 fluorescence detector must have a Raman signal-to-noise of at least 2100 when using dark signal as noise reference.

• UHPLC System 2 fluorescence detector must have excitation wavelength range of at least

200 to 630 nm and emission wavelength range of at least 220 to 650 nm.

• UHPLC System 2 fluorescence detector must use a Xenon flash lamp light source.

• UHPLC System 2 fluorescence detector must have wavelength accuracy of at least ± 2 nm and wavelength repeatability of at least ± 0.2 nm.

• UHPLC System 2 fluorescence detector must have wavelength switching time less than 250 ms.

• UHPLC System 2 fluorescence detector shall be provided with two (2) flow cells that are either end-user exchangeable or exchangeable by field installation, one (1) having a maximum volume of 8 µL and one (1) having a maximum volume of 2 µL.

Software Requirements for UHPLC System 1 and UHPLC System 2:

• Contractor must provide a total of two (2) software packages, one (1) per UHPLC system, for controlling the UHPLC systems and for analyzing measured data and experimental parameters.

• Contractor must provide an additional one (1) software package for offline analysis of data from the UHPLC systems.

• Software must be able to be installed on a NIST owned Windows 10-based PCs, one per

UHPLC system. NIST will not require purchase of PCs from the Contractor. Contractor may provide minimum required specifications for the NIST-provided PCs.

• Contractor must provide any hardware necessary for interfacing the NIST provided PCs with the instruments.

Data acquisition software must simultaneously control all hardware components without the use of third-party device drivers.

Initial Warranty:

The Contractor shall provide, at a minimum, a one-year warranty for the equipment. The warranty shall cover all parts, labor and travel. The warranty shall commence upon successful completion of delivery, installation, training and demonstration of all required specifications.

Extended Warranty (Option Year 1-Option Year 2):

The Contractor shall provide options to extend the initial one (1) year warranty, for up to an additional two (2) years, in one-year increments. The extended warranty shall also include at least one annual preventative maintenance servicing, including parts, labor and travel.

Installation:

The Contractor shall install the instrument at NIST/IBBR in Rockville, MD. 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. Installation shall take place 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 Contracting

Officer’s Representative (COR) or Subject Matter Expert (SME). Installation shall occur within

30 calendar days after delivery.

Training:

The Contractor shall provide in person training at NIST/IBBR for up to 2 NIST personnel covering normal operation, troubleshooting, and routine maintenance. Training shall 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 COR or SME to ensure maximum availability of NIST personnel. Training shall occur within 10 calendar days of installation. The training may be completed on-site at NIST immediately after installation and demonstration of specifications.

III. PERIOD OF PERFORMANCE

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

Initial Warranty: FY 2023 to FY 2024

Extended Warranty Option Year 1: FY 2024 to FY 2025

Extended Warranty Option Year 2: FY 2025 to FY 2026

IV. PLACE OF PERFORMANCE

Installation of the instrument and training shall be accomplished at NIST/IBBR, Rockville, Maryland. Normal duty hours are Monday through Friday, 8:30 a.m. to 5:00 p.m. with the exception of Federal holidays.

V. DELIVERY

Delivery terms shall be FOB Destination and shall be accomplished at NIST/IBBR, Rockville, Maryland. Normal duty hours are Monday through Friday, 8:30 a.m. to 5:00 p.m. with the exception of Federal holidays, and will be coordinated with the NIST COR or SME. Delivery shall occur within 120 calendar days of award.

VI. DELIVERABLES

Description Quantity Due Date

UHPLC System 1 without fluorescence detector

One (1) 120 calendar days after award.

UHPLC System 2 with fluorescence detector

One (1) 120 calendar days after award.

Software packages for controlling UHPLC systems and analyzing data

Two (2) 120 calendar days after award.

Software package for off-line data analysis One (1) 120 calendar days after award.

Installation of two analytical instruments Once 30 calendar days after delivery.

Operations and maintenance manual(s) for the UHPLC systems

(either in electronic or hard-copy format)

One (1) set

120 calendar days after award.

Training of NIST personnel at NIST/IBBR, Rockville, MD

Once 60 calendar days after installation.

Option Year 1: Extended Warranty One (1) year Upon exercise of option year.

Option Year 2: Extended Warranty One (1) year Upon exercise of option year.

VII. ACCEPTANCE CRITERIA

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

GENERAL INFORMATION

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

Security: NIST/IBBR is a restricted campus. An identification badge is required for access for entry into buildings and may be obtained from the security desk upon arrival.

Identification Badges: Contractor employees shall comply with NIST/IBBR identification and access requirements. Each Contractor employee shall wear a visible identification badge provided by the NIST/IBBR security desk.