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Stunner AF system

Active

Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

General Info

Agency

Food and Drug Administration → Food And Drug AdministrationView Agency

NAICS

334516 - Analytical Laboratory Instrument ManufacturingView NAICS

Place of Performance

USA

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

PostedJan 1

forecast

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Organization & Contact Information

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AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / Agency

Food and Drug Administration → Food And Drug Administration

View Agency Profile

Office AddressN/A

Contacts

Nick Sartain

contact@example.gov

Nick SartainContracting Officer

contact@example.gov

Full Description

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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.

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