Articles by Antony Hitchcock
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Do We Really Understand Plasmid Quality's Effects On mRNA Production?
5/1/2025
Two experts examine the current guidelines and specs for plasmid DNA and question whether our understanding is sufficient.
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Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why
11/19/2024
The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.
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Have We Got Novel Drug Production And Compliance Timelines All Wrong?
6/13/2024
Drug developers might want to consider longer-term approaches to meeting manufacturing and regulatory requirements.
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What Proposed Plasmid DNA Standards Say For GMP/Non-GMP Production
3/8/2024
Today’s standards for plasmid DNA production lack specificity, and manufacturers have been clamoring for more. In late 2023, USP published draft General Chapter <1040> to help fill in the cracks.
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4 Focus Areas To Improve AAV Production Lines
12/18/2023
AAV-vectored drugs can potentially treat population-level diseases. But biopharmaceutical companies will have to get better at producing them in bulk. Here are some areas to focus on.
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Building AAV Manufacturing Capacity For Large Patient Diseases
11/15/2023
AAV-based gene therapies are poised to treat larger patient populations with diseases like cardiovascular and neurological conditions. But scaling poses safety and manufacturing challenges. This deep dive into the issues could help companies clear away some of those obstacles.