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Bio-Rad Introduces Vericheck ddPCR Empty-Full Capsid Kit for AAV Analysis

Enables optimization of AAV vector characterization processes to streamline gene therapy development and production while supporting compliance.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

Bio-Rad Laboratories Inc., a leader in life science research and clinical diagnostics products, has launched the Vericheck ddPCR Empty-Full Capsid Kit for the determination of capsid titer, genome titer, and percentage of full capsids in purified or unpurified (crude lysate) AAV samples.
 
Using Bio-Rad’s Droplet Digital PCR technology, the new Vericheck ddPCR Empty-Full Capsid Kit analyzes minimal amounts of either crude lysate or purified samples to deliver robust, reproducible data for reliable assessment of AAV vector quality. Designed for use on Bio-Rad’s Droplet Digital PCR Systems, the kit’s cost-effective and accessible solution enables optimization of AAV vector characterization processes to streamline gene therapy development and production while supporting compliance with regulatory guidelines.
 
“AAV vectors are a powerful gene therapy tool, but their production can result in the generation of product-related impurities, such as partial or empty capsids, which impact effectiveness and can elicit unwanted immunotoxicity. Determining the ratio of full, partial, and empty capsids is a recurring challenge throughout AAV gene therapy manufacturing, from early-stage development to quality control and release testing,” said Stephen Kulisch, Vice President of Marketing for Bio-Rad’s Digital Biology Group. “Our new Vericheck ddPCR Empty-Full Capsid Kit delivers unmatched precision and specificity, along with ease of use and high-throughput capabilities, to provide our customers with a comprehensive solution for AAV vector characterization and to help drive the advancement of safe and effective gene therapies.”

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