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 MoreTech Note 5: SIMI: A Different Approach to Revealing Dangerous Subvisible Impurities
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Read MoreGene Therapy: Critical Quality Attributes of Viral Vector and Lipid Nanoparticle Stability
There is a growing appreciation that the biggest hurdle toward realizing the full clinical potential of human gene therapy and…
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 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 MoreCharacterizing the Stability of Gene Therapy Products at Ultra Low Volume
In this GEN webinar, Dr. Bernardo Cordovez will discuss Aura® GT and how to characterize gene therapies for stability and…
Read MoreHigh Throughput Characterization Of Antibody, AAV And Cell Therapy Aggregates And Particulate Impurities Using The Aura
Presented live at Oxford Global’s Biotherapeutics US conference held in Boston, MA, Dr. Bernardo Cordovez presented how to identify protein…
Read MoreHigh Throughput, Low Volume Product Stability and Purity Analysis for AAV and Lentiviral Gene Therapies
Aura+ is the latest instrument designed specifically to detect, count, and characterize subvisible aggregates and extrinsic materials for product quality…
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