Statement of Requirement (Final).pdf

STATEMENT OF REQUIREMENT

TITLE: Procurement of a microfluidic electrophoretic separation technology-based instrument 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 at-line rapid measurements of protein properties. It is anticipated that an instrument using microfluidic electrophoretic technology will meet this need with a specific brand name requirement of the PerkinElmer LabChip GXII Touch HT Protein

Characterization System.

II. SPECIFICATIONS

The Contractor shall deliver, install and provide training for one (1) PerkinElmer LabChip GXII

Touch HT Protein Characterization System having specifications described below.

Hardware and Software Requirements:

• The instrument must be a new instrument and not be a refurbished instrument.

• The instrument must be a microfluidic electrophoretic separation technology-based instrument suitable for the analysis of proteins either purified or in complex matrices such as cell culture media and for the analysis of glycans released from proteins by enzymatic digestion.

• The instrument must be able to perform separations by sodium dodecylsulfate– polyacrylamide gel electrophoresis (SDS-PAGE) and capillary zone electrophoresis (CZE) methods.

• The instrument must use laser-induced fluorescence as method of detection for proteins and glycans.

• The instrument must function as a class 1 laser device during normal operation. Lasers of higher class used for the instrument’s function must be embedded into the instrument with sufficient protection (shielding, interlocks, etc.) so that a user during normal operations cannot be exposed to laser power greater than that of a class 1 laser device.

• The instrument must have an autosampling capability compatible with samples provided in

96-well and 384-well microplates conforming to American National Standards Institute

(ANSI) and Society for Laboratory Automation and Screening (SLAS) standards for microplate footprint dimensions (ANSI/SLAS 1-2004(R-2012)) and well positions

(ANSI/SLAS 4-2004(R-2012)).

• The instrument, when operating in SDS-PAGE mode for protein samples, must automatically combine an internal molecular weight standard with the sample prior to separation.

• The instrument, when operating in SDS-PAGE mode for protein samples, must be able to detect proteins having concentration at minimum greater than or equal to 5 micrograms per milliliter (μg/mL).

• The instrument, when operating in SDS-PAGE mode for protein samples, must be able to detect proteins with molecular masses at minimum between 5 to 200 kilodaltons (kDa) with at minimum ± 20% accuracy and at minimum ± 10% resolution in molecular mass.

• The instrument, when operating in SDS-PAGE mode for protein samples, must provide quantitative reproducibility of measured protein concentration of at minimum 30% CV for molecular masses from 5 to 120 kDa.

• The instrument, when operating in SDS-PAGE mode for glycan samples, must have quantitative reproducibility of measured glycan concentration of at minimum 10% for peaks greater than or equal to 2.5% of total measured glycan.

• The instrument, when operating in CZE mode, must have quantitative reproducibility of at minimum 5% for measured relative abundance of charge variant species.

• The instrument must be able to perform at least size characterization analysis in < 2 minutes per sample.

• The instrument and consumable reagents must be compatible with protein samples in having salt concentrations as high as 1 mole per liter (mol/L, molar) sodium chloride.

• Instrument operation must include the use of automated routines for loading necessary reagents, aligning optics and/or calibrating detection, automatic sampling, separation, detection, and preliminary analysis of resulting data in the forms of converting data to appropriate scale (e.g.: molecular mass for SDS-PAGE modes) and integrating electrophoretic peaks.

• The instrument must include, either via onboard computer and/or controller or by connected windows-based personal computer (PC), software enabling analysis and visualization of data to include at minimum calibration of separation scale and conversion to relative and/or absolute units (e.g.: molecular weight, relative charge, etc.), identification and integration of electrophoretic peaks, comparison of peak intensities in relative and/or absolute units, overlaying of electropherograms from multiple samples, and data presentation in electropherogram and gel migration views.

• The instrument must include at least one copy of software necessary for off-line analysis of data collected by the instrument having at minimum the same analysis capabilities of the onboard or connected analysis software.

• The instrument must be provided, either in hard copy or electronic format, with an operations and maintenance manual covering proper operation, routine maintenance, and troubleshooting for the instrument and controlling software.

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 the NIST Subject Matter Expert (SME). Installation shall occur within 60 calendar days of 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 8:30am and 5:00pm Eastern Time, Monday through Friday, except Federal Holidays, and will be coordinated with the NIST COR to ensure maximum availability of NIST personnel. Training shall occur within 60 calendar days of installation and 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

LabChip GXII Touch HT instrument One (1) 120 calendar days after award of this requirement.

Operations and maintenance manual(s) for the analytical instrument

(in either electronic or hard-copy format)

One (1) set

120 calendar days after award of this requirement

Installation of the analytical instrument Once 60 calendar days after delivery

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.