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Octet RH96 High-throughput BLI plate reader

ID: 75F40125Q00237 • Type: Solicitation • Match:  100%
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Description

The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research (OPQR), has a requirement for an Octet RH96 instrument that utilizes Biolayer Interferometry (BLI) to support high-throughput potency assays, antibody titer measurement (both whole and fragmented), host cell protein quantitation, residual Protein A detection, and kinetic analyses, as detailed in the attached Performance Work Statement (PWS).

Background
The U.S. Food and Drug Administration (FDA), specifically the Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research (OPQR), has a requirement for an Octet RH96 instrument. This instrument utilizes Biolayer Interferometry (BLI) technology to support various high-throughput assays including potency assays, antibody titer measurement, host cell protein quantitation, residual Protein A detection, and kinetic analyses. The goal of this contract is to enhance the FDA's capabilities in pharmaceutical quality research.

Work Details
The contract requires the delivery of an Octet RH96 High-throughput BLI plate reader with the following specifications:
- Label-free, fluidics-free, real-time detection capabilities.
- Ability to measure protein affinity, size, and kinetics, including binding constants (k_obs, k_a, k_d, and K_D).
- Analyze up to 96 samples simultaneously; must accommodate two 96-well or two 384-well plates.
- Accurate quantitation of target proteins (e.g., IgG) in crude samples such as harvested cell culture fluid with a linear range of 0.05 µg/mL to 2000 µg/mL.
- Capability to quantify CHO host cell proteins and residual Protein A concentrations.
- Non-destructive sample analysis allowing for sample recovery.

The system must include:
- Octet RED96e Rapid Extended System which contains:
- Instrument
- Computer
- Software license
- Installation and Qualification services including setup and operational qualification (IQ/OQ).
- On-site software walkthrough for up to eight personnel.
- Warranty covering all parts and labor for a minimum of one year.

Accessories required include:
- Protein A Biosensors – 20 trays of 96 biosensors
- Host Cell Protein Detection Kit (CHO) – 5 assay kits
- High-Precision Streptavidin (SAX) Biosensors – 5 trays of 96 biosensors
- Evaporation Covers (3-pack) – quantity: 5.

Period of Performance
The period of performance shall be one year from the date of delivery and installation of the instrument.

Place of Performance
Delivery Location: FDA CDER, Building 72, Second Floor Labs, 10903 New Hampshire Avenue, Silver Spring, MD 20903.

Overview

Response Deadline
Aug. 5, 2025, 12:00 p.m. EDT Past Due
Posted
July 25, 2025, 1:46 p.m. EDT
Set Aside
Small Business (SBA)
Place of Performance
Silver Spring, MD 20903 United States
Source

Current SBA Size Standard
1000 Employees
Est. Level of Competition
Average
Est. Value Range
Experimental
$150,000 - $250,000 (AI estimate)
On 7/25/25 Office of Government Contracting Services issued Solicitation 75F40125Q00237 for Octet RH96 High-throughput BLI plate reader due 8/5/25. The opportunity was issued with a Small Business (SBA) set aside with NAICS 334516 (SBA Size Standard 1000 Employees) and PSC 6640.
Primary Contact
Name
ERIKA CRAWFORD   Profile
Phone
None

Additional Contacts in Documents

Title Name Email Phone
None Linda Finan Profile linda.finan@fda.hhs.gov None

Documents

Posted documents for Solicitation 75F40125Q00237

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Additional Details

Source Agency Hierarchy
HEALTH AND HUMAN SERVICES, DEPARTMENT OF > ADMINISTRATION FOR CHILDREN AND FAMILIES > ACF OFFICE OF GOVERNMENT CONTRACTING SERVICES
FPDS Organization Code
7590-75ACF1
Source Organization Code
500169879
Last Updated
Aug. 20, 2025
Last Updated By
erika.crawford@fda.hhs.gov
Archive Date
Aug. 20, 2025