Aldevron Breakthrough Blog

Plasmid DNA Insights: Expanded Focus on CMC in Gene & Cell Therapy Development

Aldevron recently hosted a webinar through Endpoints news titled: Plasmid DNA Insights: Expanded Focus on CMC in Gene and Cell Therapy Development.

Arsalan Arif, the publisher and founder of Endpoints News moderated the well-balanced, industry expert guest panel featuring Dr. Anthony Davis, Chief Executive of Dark Horse Consulting, Ken Bonnell, SVP of Quality and Regulatory at Aldevron; Biswarup Dasgupta, Director of Quality Assurance at Sarepta; and Frank Bonnelly, Director of Supply Chain at Encoded.

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Contributing to a Cure for Sickle Cell Disease

Every year, an estimated 300,000 children are born globally with a severe form of sickle cell disease. This is a genetic disease that causes red blood cells to be a sickle shape, leading to episodes of pain and anaemia, along with the potential of stroke or kidney damage.

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Improving CRISPR Genome Editing to Treat Genetic Disease

CRISPR genome editing has enormous potential as a means to treat genetic disorders, such as sickle cell disease. However, despite massive success in pre-clinical experiments, the impact of CRISPR in the clinic has been relatively limited.

One problem is a lack of options for large-scale delivery of CRISPR enzymes to patients.

Earlier this month, Aldevron and Synthego co-sponsored a GEN webinar exploring excitingnew research into how to deliver genome editing enzymes in vivo into patient cells.

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Evaluating Quality Systems with Your Manufacturing Partners

A common question we receive from clients is how to evaluate a new manufacturer's quality system, and how to verify that it complies with global regulatory bodies' prescribed guidance, especially since the landscape surrounding regulatory guidance is constantly changing as the cell and gene therapy industry evolves.

Luckily, I was fortunate enough to sit down with Ken Bonnell, Aldevron’s Senior Vice President of Quality and Regulatory Affairs, to learn more about how to evaluate manufacturing partners, what to look for, and what is important. You can continue to read our conversation in this article or listen by checking out the video below!

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Top things to consider when returning to the lab in the era of COVID-19

The work you perform is essential, and returning to the lab during the COVID-19 era poses several challenges. When you work with a safety-first mindset during your workday and follow the lab and local government regulatory guidelines, you may continue to carry out your essential duties while posing little risk to yourself and those around you. Here are some tips on how to smoothly transition back to work in the lab.

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Investments in Innovative Methods: Rapid Sterility Testing

Speed, control and comparable results: these are among the foremost needs of contract development and manufacturing organizations (CDMOs) and our clients when it comes to plasmid DNA that will be used to support cell and gene therapy at a research, clinical and commercial level. As an early adopter of rapid sterility testing, Aldevron delivers on all three.

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What to Consider When Using DIY Kits for Plasmid DNA Production

Plasmid DNA purification has come a long way since Herbert Boyer and Stanley N. Cohen's experiments in the early 1970s. Molecular biology is now dominated by the various ways recombinant DNA and RNA can be manipulated, and purification techniques have evolved to meet this demand. In sharp contrast to the complicated, labor-intensive efforts that were needed in previous decades to extract even a small amount of DNA, there are now numerous easy-to-use DIY kits available that enable researchers to obtain the DNA they need.

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