SOR- High-Throughput-Final_8-13-25.docx

STATEMENT OF REQUIREMENT

TITLE: High-Throughput Circular Dichroism for Analysis of Biotherapeutics

BACKGROUND INFORMATION

The Biomolecular Measurement Division (BMD) of the Materials Measurement Laboratory (MML) at the National Institute of Standards and Technology (NIST) and the NIST Center for Neutron Research (NCNR), advance measurement methods to determine structure and function of therapeutically relevant biological molecules, monoclonal antibodies, DNA, RNA, proteins, lipids, antimicrobial molecules, and the complexes formed by these molecules, as part of the NIST Biomanufacturing Initiative and the NIST’s Innovations in Measurement Science (IMS) projects.

Multiple biomanufacturing projects involve the measurement of the changes in the structural and physical attributes of biotherapeutics under different (100s to 1000s of samples) formulation and accelerated stress conditions to inform on quality. These studies aim to generate large, high-quality datasets to inform Artificial Intelligence (AI) models on such things as drug stability and efficacy. In addition, the BSFG is involved in the IMS award “Reflectometry-driven Optimization And Discovery of Membrane Active Peptides (ROADMAP)” - a joint effort between NIST-BMD, NCNR, NIST-ITL that aims to establish a workflow for rapid discovery of potent peptide candidates for biomedical applications including combating microbial resistance by combining rapid experimental measurements and Artificial Intelligence (AI) models. An important component of this work is the efficient data acquisition from hundreds of peptide samples and their rapid characterization in terms of secondary structure and molecular interactions with lipids.

The BSFG therefore requires purchase of a high-sensitivity, high-throughput circular dichroism (CD) instrument with an integrated, automated liquid handling system for unattended, reliable and reproducible measurements of multiple samples. This instrument would support measurements of identity, stability, and higher order structure of peptide, protein and oligonucleotide therapeutics, therapeutic candidates, and the reference materials developed by NIST to support these drug platforms. The fast data acquisition system will be essential for providing AI models with structural information, as well as for assessing structural stability of biological material with time and under various conditions.

I. SPECIFICATIONS

The Contractor shall deliver, install and provide training for one (1) High-Throughput CD instrument meeting all specifications below.

General Hardware Requirements:

· The instrument must be new hardware and not refurbished hardware.

· The instrument must contain a fully integrated robotic system for automated sample loading, based on 96-well sample plates or tube racks

· The instrument must be provided with an intense, continuous light source producing wavelength in the range of 180 nm to 1000 nm, or broader

· The instrument must have a high sensitivity light detector system (avalanche photodiode preferred, for low electronic noise and high spectral response)

· The instrument must be of high sensitivity, permitting measurements of very dilute samples (as low as 0.05 milligram per milliliter of a protein solution)

· The instrument must have and integrated Nitrogen (N2) purge system

· The instrument must have a system for wavelength calibration.

· The instrument must have an integrated multiple wavelength calibration system of the CD signal amplitude that ensures accurate CD values over the entire range (180 nm to 1000 nm )

· The instrument must be capable of measuring simultaneous CD and Absorbance signals.

· The instrument must have an integrated Peltier-based temperature controller for the sample, capable of a temperature range: -10 oC to 100 oC

· The instrument must be provided with sample plate temperature control in the range of 0 oC to 50 oC, or broader

· The instrument must be provided with a desktop computer to be used for control of the instrument and data collection

· The instrument must be provided with operations and maintenance manual for the measurement system (in either electronic or hard-copy format)

General Software Requirements:

The Contractor must have the instrument control software installed on the computer provided with the instrument.

If the use of manufacturer-specific or proprietary software is necessary for offline review and analysis 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:

· The instrument control software must be capable of programmable, automated: 1) sample change; 2) measurement and, 3) cell wash cycle protocols

· The software must allow both manual and automatic data collection

· The software must include an instrument wavelength calibration routine

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.

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. One preventative maintenance (PM) visit is required during the first-year warranty, which will include a new lamp, filter, instrument calibration, and testing. The warranty shall commence upon Government acceptance.

Extended Warranty (Option Year 1 to Option Year 4):

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 include instrument repairs to include parts, labor and travel costs. Each optional additional warranty year shall also include an annual preventative maintenance (PM) service, which will include a new lamp, filter, instrument calibration and testing. The PM can occur at any point during the PoP but must be completed by the end date of the PoP.

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.

II. PERIOD OF PERFORMANCE

Delivery is within 90 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.

Exact dates will be provided at the time of award.

III. 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.

IV. 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. See Deliverables schedule for delivery details.

V. DELIVERABLES

Operations and maintenance manual for the measurement system (in either electronic or hard-copy format) One (1) set Within 30 calendar days after delivery

VI. ACCEPTANCE CRITERIA

Formal acceptance shall be given by the Government when the Contractor demonstrates that all specifications in this statement of requirement have been met (inclusive of delivery, installation, and training).

VII. 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.