Attachent 1 SOW.docx

STATEMENT OF WORK

Acquisition of a High-Throughput Microelectrode Array (MEA) Electrophysiology and Impedance System

1. INTRODUCTION AND BACKGROUND

FDA's Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP), Office of Gene Therapy (OGT), requires a new high-throughput microelectrode array (MEA) platform to support a regulatory science project. The project will develop a human brain assembloid platform integrated with real-time electrophysiological profiling as a New Approach Methodology (NAM) to support regulatory evaluation of adeno-associated virus (AAV)-mediated gene therapies for central nervous system (CNS) disorders. This is a new requirement; the laboratory does not currently possess an MEA platform with the capabilities required for this project.

The Government requires a complete, commercially available system that meets or exceeds the minimum functional and performance requirements stated herein. Brand names, proprietary model names, manufacturer-specific part numbers, and vendor quotation references are intentionally excluded. Solutions may use different technical approaches provided the offered system satisfies all minimum requirements and is suitable for the stated research applications.

2. SCOPE OF WORK

The Contractor shall:

a. Deliver one (1) new, complete high-throughput MEA electrophysiology and impedance measurement system, including all hardware, software, computer equipment, accessories, starter consumables, and other components necessary for full operation.

b. Perform on-site installation of all hardware and software, including system setup, calibration, configuration, and verification that the installed system meets the manufacturer's published performance specifications and the requirements of this Statement of Work.

c. Provide on-site user training for up to two (2) days covering system operation, data acquisition, data analysis, stimulation, impedance measurement, environmental controls, and applications relevant to neural organoid/assembloid electrophysiology.

d. Provide all software licenses required to operate the system and perform the required acquisition and analysis functions, with a minimum of two (2) user seats where seat-based licensing applies.

e. Provide all documentation required for safe and effective operation, including user manuals, installation documentation, warranty information, and applicable certificates of conformance.

f. [OPTION YEAR 1] Provide on-site performance assurance and preventive maintenance for twelve (12) months following expiration of the standard warranty, including parts, labor, system performance verification, and at least one (1) on-site preventive maintenance visit.

3. MINIMUM TECHNICAL AND PERFORMANCE REQUIREMENTS

The offered system shall meet or exceed the following minimum salient characteristics. Equivalent or superior capabilities are acceptable when they fulfill the intended function.

3.1 General Capabilities

High-throughput, non-invasive, label-free platform capable of real-time in vitro electrophysiology recording and electrical stimulation using microelectrode arrays.

Integrated impedance measurement capability for real-time monitoring of cell attachment, viability, morphology, proliferation, or related impedance-based parameters.

Compatibility with both two-dimensional monolayer cultures and three-dimensional biological models, including spheroids and organoids/assembloids.

Suitable for use with induced pluripotent stem cell (iPSC)-derived neural cultures and other excitable cell types.

3.2 Electrophysiology Recording and Stimulation

At least 768 simultaneous recording channels across the supported plate format(s).

Sampling rate of at least 12.5 kHz per recording channel.

Recording bandwidth covering at least 0.01 Hz through 5 kHz.

Electrical stimulation capability available across recording electrodes/channels, with programmable voltage and/or current stimulation sufficient for neural electrophysiology applications; the system shall support stimulation amplitudes of at least ±1.2 V and ±250 µA, or an equivalent stimulation range demonstrated to meet the intended application.

Real-time visualization of electrophysiological activity during acquisition.

3.3 Impedance Measurement

Integrated, automated, real-time impedance monitoring without requiring a separate external instrument.

Impedance measurement range sufficient to support electrode quality assessment and cell-based viability/attachment assays, including coverage of approximately 50 ohms through 100 kilohms or broader.

3.4 Multiwell Plate Compatibility and Throughput

Support for MEA measurements in multiple multiwell formats, including at minimum 24-, 48-, and 96-well MEA plates, or an alternative combination providing equivalent or greater throughput and experimental flexibility.

Support for impedance measurements in high-throughput multiwell formats of at least 96 wells; support for formats up to 384 wells is preferred.

System shall include sufficient starter consumables to support initial neural culture/3D model experiments in both medium- and high-throughput formats.

3.5 Environmental Control

Integrated environmental chamber or equivalent enclosure capable of maintaining physiological experimental conditions during extended recordings.

Active temperature control capable of maintaining approximately 37°C and adjustable over a range sufficient for mammalian cell culture experiments.

CO2 control covering at least 0-10% and humidity control or equivalent evaporation-mitigation capability.

Environmental controls shall permit experiments without requiring the instrument to be placed inside an external cell-culture incubator.

3.6 Software and Data Capabilities

Integrated software for instrument control, data acquisition, real-time visualization, stimulation control, and analysis.

Analysis capabilities suitable for neural electrophysiology, including detection and characterization of spikes, bursts, network activity, and related quantitative metrics.

Impedance acquisition and analysis capability, including cell viability/quality monitoring.

Ability to export raw and/or processed data in commonly usable formats for downstream analysis.

Automation capability through a documented application programming interface (API) or software development interface compatible with at least one commonly used scientific programming environment (e.g., Python, MATLAB, C#, or equivalent).

Where regulated-workflow functionality is offered, software controls supporting electronic records/electronic signatures or 21 CFR Part 11-aligned workflows are preferred but are not required unless separately specified in the order.

3.7 Physical, Electrical, and Computing Requirements

Benchtop instrument suitable for installation in a standard biomedical research laboratory.

Compatible with standard U.S. laboratory electrical service (100-240 V AC, 50/60 Hz, or equivalent with appropriate supplied power accessories).

Contractor shall provide a computer and monitor meeting or exceeding the manufacturer's requirements for all furnished software and system functions.

3.8 Research Application Suitability

Neural electrophysiology using 2D and 3D cell culture models, including organoids/assembloids.

Neurotoxicity and safety assessment applications.

Dose-response and pharmacology studies.

Cell viability, proliferation, and related impedance-based assays.

4. DELIVERABLES

The Contractor shall provide the following deliverables:

5. PERIOD OF PERFORMANCE

Base Period: The base period commences on the date of award and extends through completion of all base-period deliverables. Equipment delivery (D1) shall occur within 90 days of award. On-site installation and system verification (D2 and D3) shall be completed within 30 days of equipment delivery. User training (D4) shall be completed within 60 days of equipment delivery.

Warranty: The base requirement shall include a standard manufacturer warranty of at least one (1) year covering defects in design, materials, and workmanship. Warranty coverage shall begin no earlier than installation/acceptance unless the manufacturer's standard commercial warranty provides more favorable coverage to the Government.

Option Year 1: If exercised, the option shall provide twelve (12) months of on-site performance assurance and preventive maintenance commencing immediately after expiration of the standard warranty. The option period shall not overlap with included warranty coverage.

6. PLACE OF PERFORMANCE

All deliveries, installation, and training shall be performed at:

U.S. Food and Drug Administration Center for Biologics Evaluation and Research (CBER) Building 52/72, Room 3148 10903 New Hampshire Avenue Silver Spring, MD 20993 The Contractor shall coordinate delivery scheduling and building access with the COR at least five (5) business days before planned delivery, installation, or on-site service dates.

7. INSPECTION AND ACCEPTANCE

All equipment and services furnished under this requirement are subject to inspection and acceptance by the Contracting Officer's Representative (COR) or other designated Government representative at the destination specified in the contract. The Contractor shall provide written notification to the COR at least five (5) business days before delivery of equipment.

The Government will inspect delivered equipment for conformance with this Statement of Work, including verification of quantity, physical condition, completeness, required documentation, and the minimum technical and performance requirements in Section 3. During installation and system verification, the Government may require demonstration of key functions sufficient to establish that the system is operational and conforms to the accepted offer and contract requirements.

The Government may reject nonconforming equipment or services and require repair, replacement, reperformance, or other correction at no additional cost to the Government, subject to the terms and conditions of the contract. Acceptance shall be documented by the Government and shall not waive rights concerning latent defects, fraud, gross mistakes amounting to fraud, or other rights provided by the applicable contract clauses.

8. CONTRACTOR TECHNICAL RESPONSE

To facilitate technical evaluation, the Contractor shall provide sufficient product literature and a compliance matrix identifying how the offered system meets each minimum requirement in Section 3. The response shall clearly identify any requirement that is met through an equivalent technical approach and explain how the proposed capability satisfies or exceeds the stated functional need. Unsupported statements of compliance may be considered insufficient for technical evaluation.

9. GOVERNMENT POINTS OF CONTACT

Principal Investigator, Senior Staff Fellow

FDA/CBER/OTP/OGT

Room 3110, Building 52/72 10903 New Hampshire Ave.

Silver Spring, MD 20993 Tel: 301-796-2441 dwi.kemaladewi@fda.hhs.gov

Contracting Officer, OAGS FDA Office of Acquisitions and Grants Services (OAGS) michele.jackson@fda.hhs.gov