Aldevron Breakthrough Blog: Quality

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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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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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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Virtual Facility Audits Now Available

Challenging times require creative solutions. Especially now, when in-person contact is discouraged yet first-hand, observed information is critical, we all depend on fresh ways to think about how we provide access and insight.

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