Statement of Requirements.pdf

STATEMENT OF REQUIREMENT

Protein Biologic Analyzer

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.

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 mammalian cell culture clonal screening, colony outgrowth and protein biologics titer and glycan measurements.

II. SPECIFICATIONS

The Contractor shall deliver, one (1) Solentim ICON instrument meeting all specifications below. The Contractor shall deliver instrument consumables as specified below:

General Hardware Requirements shall:

• New hardware and not refurbished hardware.

• Include autosampling capability accommodating at least 10 samples at a time.

• Controlled by either an integrated controller or by a connected computer and automated so that all measurements can be performed using defined protocols with no manual interventions required during normal operation other than autosampler loading.

• Include defined protocols for calibration and/or quality control of all measured parameters to within manufacturer-specified tolerances.

• Provide at least one copy of manual(s) for user operation and maintenance of the instrument in either electronic or hard copy format.

General Software Requirements:

If the use of manufacturer-specific or proprietary software is necessary for offline review of measured data or for exporting of measured data to a plaintext format, such as comma separated values (.csv), the Contractor must include one (1) copy of such software compatible with installation on a NIST-provided Windows-10 based personal computer (PC).

Specifications, shall:

• Be able to measure samples of mammalian cell cultures containing suspended cells.

• Measure proof of clonality by imaging single cells in a whole well plate

• Measure protein concentration from 2.5 mg/L to 2000 mg/L

• Be capable of viable cell counting

• Be able to track colony outgrowth from day 0 to full confluency

• Be capable of glycan analysis for mannose, galactose, fucose, 2,3-sialic acid, 2,6-sialic acid, and sialic acid on O-glycans.

• Be capable of automated data monitoring, analysis and reporting for per cell protein yield and glycan distribution.

Required Consumables (3 of each):

• 384 PAIA Glycan Assay Plate pre-loaded with functionalized beads

• Lectins specific for the following glycans:

o Fucose on N-glycans o Galactose on N-glycans o Mannose on N-glycans o 2,6 linked sialic acids on N-glycans o 2,3 linked sialic acids on N-glycans o Sialic acids on O-glycans

• PAIAmix Sample Buffer

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. Instrument shall operate to manufacturer’s specifications upon installation. Installation will 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). Installation shall occur within 60 calendar days of delivery.

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 Government acceptance.

Extended Warranty:

The Contractor shall provide options to extend the initial one (1) year warranty for up to an additional four (4) years in one-year increments. The extended warranty shall also include at least one annual preventative maintenance servicing and instrument repairs to include parts, labor and travel.

Training:

The Contractor shall provide in person training at NIST/IBBR for up to 3 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 and SME to ensure maximum availability of NIST personnel. Training shall occur within 30 calendar days of installation. The training may be completed on-site at NIST immediately after installation and demonstration of specifications.

III. PLACE OF PERFORMANCE

Installation of the instrument and training shall be delivered to 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.

IV. PERIOD OF PERFORMANCE

Delivery is within 120 days of award. Anticipated dates of base and option years for initial and extended warranty are as follows:

Option Year I: FY25 to FY26 – 12 months from the end of Manufacturer’s warranty;

Option Year II: FY26 to FY27 – 12 months from the expiration of option year I;

Option Year III: FY27 to FY28 – 12 months from the expiration of option year II;

Option Year IV: FY28 to FY29 – 12 months from the expiration of option year III.

V. DELIVERY

Delivery shall be to 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. Delivery shall occur within 120 calendar days of award.

VI. DELIVERABLES

Description Quantity Due Date

Protein Biologic Analyzer One (1) system 120 calendar days after award

Software for offline data review and/or export, if required

One (1) copy 120 calendar days after award

Required consumables As described

Not before instrument delivery and within 60 calendar days after delivery Installation of the measurement system Once 60 calendar days after delivery

Operations and maintenance manual for the measurement system

(in either electronic or hard-copy format)

One (1) set 120 calendar days after award

Training of NIST personnel at NIST/IBBR, Rockville, MD Once 30 calendar days after installation

Preventative Maintenance Annually By the end date of the period of performance

VII. ACCEPTANCE CRITERIA

Formal acceptance shall be given by the COR when the Contractor demonstrates that all specifications have been met.

VIII. GENERAL INFORMATION

Safety: The Contractor 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.