Halo University: AUR102 Why upgrading to Aura can help with your SVP analysis
The Aura® suite of instruments was released onto the market in 2020. Since then, this platform has seen significant growth in adoption…
Read MoreDTR – Complete Aggregate and Particle Characterization of Protein, Gene, and Cell Therapies
In this webinar, our key speaker Dikran Khachadourian, will discuss how Aura® incorporates the techniques of Backgrounded Membrane Imaging (BMI)…
Read MoreISCT – Particulates in Cell & Gene Therapy Products: A Survey and a Solution
Particulates are everywhere but do they pose a problem in cell and gene therapy products? Blood transfusion products such as…
Read MoreComplete Characterization of Subvisible Aggregates and Impurities in Protein, Gene, and Cell Therapies Using Aura+
In all biological products, distinguishing aggregated API from other particle types matters for understanding the root cause of instability. Until…
Read MoreApp Note 22: Detecting Glass Particles – Making the Invisible Visible to Avoid the Leading Cause of Drug Recalls
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Read MoreEnsuring High Purity Cell Therapy Products: A Focus on Accurately Characterizing Cell Aggregates, Residual Dynabeads, and Other Product Impurities
Cell therapies offer unprecedented therapeutic potential for the treatment and even cure of a wide range of diseases. However, several…
Read MoreIdentification 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 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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