02 SOR- AKTA AVANT_IK2_20250428 Final.docx

STATEMENT OF REQUIREMENT

TITLE: AKTA avant 150 liquid chromatography system

BACKGROUND INFORMATION

The Bioprocess Measurements 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 counting and characterizing protein particles in biotherapeutics (2) develops methods to aid in the characterization of monoclonal antibodies (3) studies biomolecule structure and dynamics in solution using biophysical and biochemical techniques; (4) develops standards for these properties; and (5) advances measurement methods for sensors to monitor health and industrial manufacture of biological products.

In support of this mission, the Bioprocess Measurements 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 downstream process development, method optimization, and scaling up of monoclonal antibodies purification methods using various chromatographic techniques such as, affinity chromatography, gel filtration, ion exchange chromatography, and hydrophobic interaction chromatography..

I. SPECIFICATIONS

The Contractor shall deliver, install and provide training for one (1) ICON instrument meeting all specifications below. The Contractor shall deliver instrument consumables as specified below:

General Hardware Requirements:

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

· The instrument must include UNICORN 7 WrkStn avant Software

· The instrument must be controlled by a connected computer and automated so that all measurements can be performed using defined protocols.

· The instrument must include defined protocols for calibration and/or quality control of all measured parameters to within manufacturer-specified tolerances.

· The Contractor must 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:

· The instrument must have automatic in-line buffer preparation (BufferPro), pressure sensors and integrated cooled fraction collector with automatic rack validation, be able to measure samples of mammalian cell cultures containing suspended cells.

· The instrument must have a system pump comprised of 2 dual-piston pumps, (0 to 5) MPa, (0.01 to 150) mL/min

· The instrument must have a Sample pump comprised of a dual piston pump, (0 to 5) MPa, (0.01 to 150) mL/min.

· The Instrument must have a Quaternary valve to allow automated mixing of up to four different solutions

· The instrument must measure UV/visible absorbance at 3 user-defined wavelengths in the range (190 to 700) nm

· The instrument must measure conductivity: (0.01 to 999.99) mS/cm

· The instrument must measure pH: pH range 0 to 14)

· The instrument must be able to pair with analog and digital signals needed for Wyatt and other detectors.

· The instrument must have an integrated fraction collector with refrigeration capabilities, allowing for the secure storage of purified samples

· The instrument must be capable of automated data monitoring and analysis

· The instrument must be capable of automated buffer preparation, allowing for the preparation of buffers in plates and tubes

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. The warranty shall commence upon Government acceptance.

Extended Warranty (Option Year 1):

The Contractor shall provide options to extend the initial one (1) year warranty for up to an additional one (1) year. 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 or 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 Optional extended warranty The period of performance shall consist of one 12-month option period to commence at end of standard warranty period. Option year shall be exercised at the Government’s discretion:

Option Year 1: FY26 to FY27

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. Delivery shall occur within 120 calendar days of award.

V. DELIVERABLES

Operations and maintenance manual for the measurement system (in either electronic or hard-copy format) One (1) set 120 calendar days after award

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.