Aldevron Breakthrough Blog

The Pivotal Role of Plasmid DNA

Plasmid DNA has historically been key to the development of biologic drug manufacturing. Today, it plays a critical role in the production of next-generation cell and gene therapies and vaccines. With our nearly 23 years of plasmid DNA manufacturing expertise, Aldevron has helped facilitate the advance of these important therapeutics. We continue to invest in additional capacity and novel capabilities to support biopharma manufacturers into the future.
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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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