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Stunner AF system

Forecast

Federal

Contract Overview

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AI Contract Overview

The Food and Drug Administration's Center for Biologics Evaluation and Research requires an advanced analytical system to characterize Adeno-Associated Virus vectors and Lipid Nanoparticles. The primary objective is to measure critical quality attributes, specifically genome packaging efficiency, using a high-throughput platform. The system must be capable of simultaneously performing dynamic light scattering for particle sizing, UV-Visible absorbance for concentration, and fluorescence for encapsulation efficiency from a single 2 microliter sample. The Unchained Labs Stunner AF or an equivalent system is specified to meet these technical requirements. This forecast falls under NAICS code 334516 and includes provisions for four optional one-year post-warranty service agreements to ensure long-term operational support.

General Info

FDA CBER seeks an analytical system for AAV and LNP quality attribute measurement.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

334516 - Analytical Laboratory Instrument Manufacturing

Place of Performance

USA

Set-Aside

NONE

Documents

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Organization & Contact Information

AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / AgencyFood and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Nick Sartain

contact@example.gov

Nick SartainContracting Officer

contact@example.gov

Full Description

FDA, Center for Biologics Evaluation and Research (CBER), has a requirement for an analytical system with advanced, integrated multi-attribute characterization platform to enable characterization of Adeno-Associated Virus (AAV) vectors and Lipid Nanoparticles (LNPs). The laboratory develops next-generation AAV vectors and evaluates their immunogenicity and quality attributes. A critical need is the ability to measure genome packaging efficiency (empty/full ratio), which is the most important CQA for AAV products. The instrument must simultaneously measure dynamic light scattering (DLS) for particle sizing, UV-Visible absorbance for concentration quantification, and fluorescence for encapsulation efficiency (EE%) determination - all from a single, low-volume (2 L) sample in a high-throughput plate-based format. The Unchained Labs Stunner AF system or equal system, will allow measurement of all four CQAs from a single 2 L sample in one run. The requirement also has four 1-year post-warranty service agreement options.