Identification of stable cell and gene therapeutics and characterization of subvisible aggregates
In all biologics, subvisible aggregates are a critical quality attribute and key indicator of product stability. Here we present the…
Read MoreHalo 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.…
Read MoreEnsuring High Purity Cell Therapy Products: A Focus on Accurately Characterizing Cell Aggregates, Residual Dynabeads, and Other Product Impurities
There is a growing appreciation that the biggest hurdle toward realizing the full clinical potential of human gene therapy and…
Read MoreTech Note 5: SIMI: A Different Approach to Revealing Dangerous Subvisible Impurities
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Read MoreParticle Vue 21 CFR Part 11 Documentation
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Read MoreBMI 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…
Read MoreSubvisible Particle ID In Cell And Gene Therapy With The Aura CL
Introducing the Aura CL, the first subvisible particle detection platform specifically designed for cell and gene therapy applications. In as…
Read MoreIntroducing the Aura CL: Subvisible Particle Detection for Cell and Gene Therapy
Introducing the Aura CL, the first subvisible particle detection platform specifically designed for cell and gene therapy applications. In as…
Read MoreGEN Webinar – For Cell and Gene Therapy Products, Early Characterization is Critical
Years of research and innovation within the cell and gene therapy space are rapidly showing signs of success, as an…
Read MoreHalo U: Intro To Aura And BMI 101
This is our first virtual course to demonstrate the easy usability of performing high throughput, low volume subvisible particle analysis…
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