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Halo University USP788: Validating your Aura for US Pharmacopeia (USP) Sub-visible Particle Analysis

Subvisible particles (SVP) are a critical quality attribute (CQA) for protein therapeutics that can limit a product’s shelf-life and induce immunogenicity.…

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App Note 22: Detecting Glass Particles – Making the Invisible Visible to Avoid the Leading Cause of Drug Recalls

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Please fill out the form to download the app note.

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Halo U: FMM 201 and SMI 301: Subvisible Particle Identification using Side-Illumination and Fluorescence Membrane Microscopy on Protein Therapeutic Formulations

Subvisible particles are a critical quality attribute (CQA) for protein therapeutics that can limit a product’s shelf-life and induce immunogenicity.…

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Tech Note 5: SIMI: A Different Approach to Revealing Dangerous Subvisible Impurities

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Please fill out the form to download the tech note.

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Particle Vue 21 CFR Part 11 Documentation

AuraCL Spec Sheet 844x1030 1

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Aura: Particle And Aggregate Quantification, Characterization, ID, And Full USP <788> Testing

Learn how the Aura system can be a complete tool for your lab’s stability testing and quality control measurements. With…

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BMI Count And Size Validation With Aura

The Aura™ system, with its ability to count, size, and ID particles, is a powerful tool for biologics and gene…

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Biopharm Intl Webinar – Are You Seeing The Whole Picture?

In this webinar, we introduce how Backgrounded Membrane Imaging (BMI) can be used to analyze subvisible particles (SVP), an indicator…

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Seeking The Unseen: Sub-visible Particle Analysis As A Core Analytical Technique

In this webinar, Fujifilm Diosynth Biotechnologies presents comparative analytical data spanning across several different research programs then present a more…

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GEN Webinar – High Throughput Low Volume Subvisible Analysis – February 2018

Watch the latest GEN webinar where we will learn how a new particle analysis instrument called HORIZON employs backgrounded membrane…

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Discover the Aura Family

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Aura +

Obtain accurate and quantitative particle size, count, morphology, and ID info—one Aura+ system for interdisciplinary biotherapeutic labs.

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Aura PTx

Make stability, safety, and efficacy decisions earlier and get to your best antibody formulation faster with the Aura PTx (USP 788 compliant).

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Aura GT

Ensure product quality, avoid vector aggregates, and monitor DNA leakage earlier when you develop gene therapies with Aura GT.

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Maximize the purity, safety, and efficacy of your cell therapy with our simple-to-use Aura CL particle analyzer.

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Why USP 788 Matters

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Guide to Particle Size Distribution

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