Comprehensive CQA analysis for AAV drug production by multiple workflows on a single CE platform
Capabilities
At Pharmaron, we foster a strong innovation culture to ensure we are at the forefront of technology. This allows us to provide novel solutions for our customer’s cell and gene therapy (CGT) needs. Collaborating closely with vendors such as SCIEX, we utilise our extensive CGT expertise to implement novel methodologies, which help accelerate comprehensive AAV drug characterisation for our customers.
Pharmaron has an extensive analytical toolkit for analyzing plasmid and AAV critical quality attributes (CQAs), exemplified by our innovative capillary electrophoresis (CE) workflows. These allow for the comprehensive assessment of several CQAs, such as accurate and reproducible determination of plasmid purity, precise AAV purity analysis, and high-resolution AAV genome integrity characterisation. The following technical note summarizes our collaborative relationship with SCIEX, showcasing how a single CE platform, the BioPhase 8800 system, can be employed throughout the production process for streamlined quality assessment of starting materials, in-process samples, and the final drug product. Demonstrating Pharmaron’s scientific expertise and rigour, the team has incorporated SCIEX’s multi-capillary BioPhase 8800 system into Pharmaron’s analytical capabilities to allow for robust and reproducible analysis across a range of plasmid sizes and AAV serotypes.
These platform CE assays are readily available to help accelerate timelines and support the production of your AAV drug product.
To learn more about Pharmaron’s extensive analytical toolkit, please visit our Product Characterization and QC Analytic Services.
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